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{ "NCT_ID" : "NCT04005170", "Brief_Title" : "Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer", "Official_title" : "A Phase II Trial of Combination of Toripalimab and Definitive Chemoradiotherapy in Esophageal Squamous Cell Carcinoma", "Conditions" : ["Unresectable Esophageal Cancer"], "Interventions" : ["Drug: Paclitaxel/Cisplatin", "Radiation: Intensity-modulated radiotherapy", "Drug: Toripalimab"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable esophageal cancer (EC). However, as high as more than 40% of EC patients experienced locoregional recurrence after concurrent CRT. Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC. The aim of this study was to evaluate the efficacy and safety of the combination of toripalimab (an anti-PD-1 antibody) combined with definitive CRT in locally advanced esophageal squamous cell carcinoma (ESCC). #Intervention - DRUG : Toripalimab - Patients received toripalimab 240 mg on days 1 and 22 during radiotherapy followed by a maintenance phase of toripalimab IV 240 mg every 3 weeks for up to 1 year. - Other Names : - JS-001 - DRUG : Paclitaxel/Cisplatin - Patients received 5 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 during radiotherapy. - Other Names : - TP - RADIATION : Intensity-modulated radiotherapy - All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks. - Other Names : - IMRT

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of the esophagus; * Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8); * Not suitable for surgery (either for medical reasons or patient's choice); * Age at diagnosis 18 <= age <= 70; * No prior cancer therapy; * Estimated life expectancy >6 months; * Eastern Cooperative Oncology Group performance status <= 2 * No history of concomitant or previous malignancy; * The function of important organs meets the following requirements: a. white blood cell count (WBC) >= 4.0×109/L, absolute neutrophil count (ANC) >= 1.5×109/L; b. platelets >= 100×109/L; c. hemoglobin >= 9g/dL; d. serum albumin >= 2.8g/dL; e. total bilirubin <= 1.5×ULN, ALT, AST and/or AKP <= 2.5×ULN; f. serum creatinine <= 1.5×ULN or creatinine clearance rate >60 mL/min; * Ability to understand the study and sign informed consent. Exclusion Criteria: * Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.); * Patients with hematogenous metastasis disease at diagnosis; * Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs paclitaxel or cisplatin; * Patients who have a preexisting or coexisting bleeding disorder; * Female patients who are pregnant or lactating; * Inability to provide informed consent due to psychological, familial, social and other factors; * Presence of CTC grade >= 3 peripheral neuropathy; * A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer * A history of diabetes for more than 10 years and poorly controlled blood glucose levels; * Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia. * Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation; * A history of interstitial lung disease or non-infectious pneumonia; * A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment; * Presence of active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL), hepatitis C hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay). Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04005170

{ "NCT_ID" : "NCT02167958", "Brief_Title" : "Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source", "Official_title" : "Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source", "Conditions" : ["Leukemia", "MDS", "Myelofibrosis", "Lymphoma"], "Interventions" : ["Radiation: Total Body Irradiation", "Drug: Mycophenolate", "Other: Hematopoietic stem cell infusion", "Drug: G-CSF", "Drug: Tacrolimus", "Drug: Mesna", "Drug: Fludarabine", "Drug: Cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine whether stem cells collected from a donor's blood stream will be as safe and effective as using bone marrow collected from a donor's pelvic bone. Detailed Description This is a pilot study to assess the safety and potential efficacy of haploidentical peripheral blood stem cell transplantation using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide. The overall objective of this study is to collect the efficacy and safety data to provide the basis to decide whether a larger study of clinical efficacy is warranted in this setting. #Intervention - DRUG : Fludarabine - Fludarabine 30 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2. Fludarabine will be dosed according to the recipient's Adjusted Ideal Body Weight (AIBW) unless AIBW is less than Ideal Body Weight (IBW). For decreased creatinine clearance (\< 61 mL/min) determined by the Cockcroft Formula: Cockcroft-Gault CrCl = (140-age) \* (Wt in kg) \* (0.85 if female) / (72 \* Cr) Fludarabine dosage should be reduced per standard of care. - Other Names : - Fludara - DRUG : Cyclophosphamide - Pre-transplant Cy 14.5 mg/kg/day will be administered as a 1-2 hour intravenous infusion with a high volume fluid flush on Days -6 and -5. Cy will be dosed according to the recipient's actual body weight unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the adjusted IBW Post-transplant Hydration prior to cyclophosphamide may be given according to Standard Practice Guidelines. Cyclophosphamide \[50mg/kg\] will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cy will be dosed according to the recipient's actual body weight unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the adjusted IBW. Cyclophosphamide will be given as an IV infusion over 1-2 hours. . - DRUG : Mesna - Pre-transplant Mesna should be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of mesna is equal to 100% of the total daily dose of cyclophosphamide. Post-transplant Mesna should be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of mesna is equal to 100% of the total daily dose of cyclophosphamide. - Other Names : - Mesnex - RADIATION : Total Body Irradiation - 200 cGy will be administered in a single fraction on Day -1 via linear accelerator. - OTHER : Hematopoietic stem cell infusion - Donors who consent to PBSC donation will receive 5 daily doses of G-CSF, 10 μg/kg/day by subcutaneous injection commencing on day -5. PBSC's will be collected in the afternoon of day -1, stored at 4C overnight, and infused as soon as possible on day 0. If the collection on day -1 contains less than 5.0 X 106 CD34+ cells per kg recipient weight, a second collection will be performed the following morning and infused on day 0. Quantitation of CD34 and CD3 cells will be performed by the Cellular Therapy Lab. For all patients, the target number of CD34 cells to be infused should be 5-6 X 106 cells per kg recipient weight. PBSC in excess of 6.0 x 106 CD34 cells/kg recipient weight may be cryopreserved. - Other Names : - PBSC - DRUG : Tacrolimus - Tacrolimus will be given at a dose of .03 mg/kg IV over 24 hours. Tacrolimus will be changed to a PO dosing schedule once a therapeutic level is achieved and the patient is tolerating PO. Whole bloodblood levels of tacrolimus will be measured around Day 7 and then should be checked at least weekly thereafter and the dose adjusted accordingly to maintain a level of 5-10 ng/mL. Tacrolimus will be discontinued after the last dose around Day 180, or may be continued if active GVHD is present. Cyclosporine (target concentration 200-400 ng/ml) may be substituted for tacrolimus if the patient is intolerant of tacrolimus. - Other Names : - Astagraf XL, Hecoria, Prograf - DRUG : Mycophenolate - Either the sodium salt of mycophenolate or mycophenolate mofetil (MMF) may be used as prophylaxis of GvHD and will be dosed by actual bodyweight. Only MMF is available as IV formulation. Sodium mycophenolate will be given at a dose of 10mg/kg PO TID rounded to the nearest number of 180mg tablets. MMF will be given at a dose of 15 mg/kg PO TID. The maximum total daily dose should not exceed 2160 mg (sodium salt) or 3 grams (mofetil). Mycophenolate prophylaxis will be discontinued after the last dose on Day 35, or may be continued if active GVHD is present. - Other Names : - CellCept, Myfortic - DRUG : G-CSF - G-CSF will be given beginning on Day 5 at a dose of 5 mcg/kg/day (rounding to the nearest vial dose is allowed), until the absolute neutrophil count (ANC) is \> 1,000/mm3 for three consecutive days. - Other Names : - Granulocyte - Colony Stimulating Factor, Filgrastim, Neupogen®

#Eligibility Criteria: Inclusion Criteria: Subject * Age< 70. * Molecular based HLA typing will be performed for the HLA-A, -B, -Cw, DRB1 and -DQB1 loci to the resolution adequate to establish haplo identity. A minimum match of 5/10 is required. An unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6 <= age <= 8 weeks from referral or low-likelihood of finding a matched, unrelated donor. * Subjects must meet one of the disease classifications listed below: Acute leukemias (includes T lymphoblastic lymphoma). Remission is defined as < 5% blasts with no morphological characteristics of acute leukemia (e.g., Auer Rods) in a bone marrow with > 20% cellularity, peripheral blood counts showing ANC >1000/ul, including patients in CRp. Acute Lymphoblastic Leukemia in high risk CR1 as defined by at least one of the following: Adverse cytogenetics such as t(9;22), t(1;19), t(4;11), MLL rearrangements White blood cell counts >30,000/mcL Patients > 30 years Time to complete remission >4 weeks Presence of extramedullary disease Acute Myelogeneous Leukemia in high risk CR1 as defined by at least one of the following: Greater than 1 cycle of induction therapy required to achieve remission Preceding myelodysplastic syndrome (MDS) Presence of Flt3 abnormalities FAB M6 or M7 leukemia or Adverse cytogenetics for overall survival such as: those associated with MDS Complex karyotype (>= 3 abnormalities) Any of the following: inv(3) or t(3;3), t(6;9), t(6;11), + 8 [alone or with other abnormalities except for t(8;21), t(9;11), inv(16) or t(16;16)], t(11;19)(q23;p13.1) Acute Leukemias in 2nd or subsequent remission Biphenotypic/Undifferentiated Leukemias in 1st or subsequent CR. High-risk MDS status-post cytotoxic chemotherapy Myelofibrosis Burkitt's lymphoma: second or subsequent CR. Lymphoma. Chemotherapy-sensitive (complete or partial response; see response criteria Appendix C) large cell, Mantle Cell or Hodgkin's lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are ineligible for an autologous transplant or relapsed/progressed after autologous stem cell transplant. Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least two prior therapies (excluding single agent Rituxan) and are ineligible for an autologous transplant or relapsed/progressed after autologous stem cell transplant.. * Patients with adequate physical function as measured by: Cardiac: left ventricular ejection fraction at rest must be >= 35%. Hepatic: bilirubin <= 2.5 mg/dL; and ALT, AST, and Alkaline Phosphatase < 5 x ULN. Renal: serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function(creatinine clearance or GFR) > 40 mL/min/1.73m2. Pulmonary: FEV1, FVC, DLCO (diffusion capacity) >= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation > 92% on room air. Performance status: Karnofsky/Lansky score >= 60%. * Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GVHD requiring immunosuppressive therapy. Donor * Donors must be HLA-haploidentical first-degree or second degree relatives of the patient. * Age >= 18 years * Weight >= 40 kg Exclusion Criteria: Subject * HLA-matched donor able to donate. * Pregnancy or breast-feeding. * Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings). Donor 1) Positive anti-donor HLA antibody. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02167958

{ "NCT_ID" : "NCT02115607", "Brief_Title" : "Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy", "Official_title" : "Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Definity infusion"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology. #Intervention - DRUG : Definity infusion - 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min - Other Names : - Perflutren Lipid Microspheres

#Eligibility Criteria: Inclusion Criteria: * Females * Be diagnosed with T1 or greater LABC, any N and M0. * Be scheduled for neoadjuvant chemotherapy * Be at least 21 years. * Be medically stable. * If a female of child-bearing potential, must have a negative pregnancy test. * Have signed Informed Consent to participate in the study. Exclusion Criteria: * Males * Females who are pregnant or nursing. * Patients with other primary cancers requiring systemic treatment. * Patients with any metastatic disease. * Patients undergoing neoadjuvant endocrine therapy. * Patients with known hypersensitivity or allergy to any component of Definity. * Patients with cardiac shunts or congenital heart defects. * Patients with unstable cardiopulmonary conditions or respiratory distress syndrome. * Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli. * Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam. Sex : FEMALE Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02115607

{ "NCT_ID" : "NCT02767557", "Brief_Title" : "Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab in Pancreatic Cancer Patients", "Official_title" : "A Multinational, Randomized, Phase II Study of the Combination of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab, an IL-6R Inhibitor, as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Cancer.", "Conditions" : ["Unresectable Pancreatic Carcinoma"], "Interventions" : ["Drug: Gemcitabine", "Drug: Tocilizumab", "Drug: nab-Paclitaxel"], "Location_Countries" : ["Denmark", "Norway"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a multicenter center, 2-arms prospective randomized phase II trial which evaluates whether tocilizumab with gemcitabine/nab-paclitaxel is more effective than gemcitabine/nab-paclitaxel. Detailed Description The development of new effective treatment strategies remains a major challenge in patients with PC. High levels of IL-6 and presence of a systemic inflammatory response in PC patients have been reported to correlate with worse survival. Preclinical PC models have clearly shown that anti-IL-6-receptor antibody tocilizumab in combination with chemotherapy reduced tumor growth, number of distant metastases and the local recurrence rate. Thus, blockade of IL-6-regulated signaling pathways represents a promising approach in combination with chemotherapy. Elevated C-reactive protein (CRP) alone or in combination with hypoalbuminaemia (Modified Glasgow Prognostic Score - mGPS) are induced by IL-6 and could feasibly represent surrogate markers for IL-6 bioactivity to stratify patients likely to gain benefit through targeting IL-6. #Intervention - DRUG : Tocilizumab - Intravenous infusion - Other Names : - (ACTEMRA®) - DRUG : Gemcitabine - Intravenous infusion - DRUG : nab-Paclitaxel - Intravenous infusion, - Other Names : - ABRAXANE®

#Eligibility Criteria: Inclusion Criteria: * Signed informed consent * Histological or cytological pancreatic adenocarcinoma. Malignant unspecified tumor cells in cytological specimen are allowed after investigator assessment, mixed histology including adenosquamous carcinoma is allowed * Male or non-pregnant, non-lactating females who are >=18 years at the time of signing the informed consent form (ICF) * Non-curable unresectable locally advanced or metastatic pancreatic carcinoma. * A modified Glasgow Prognostic Score (mGPS) criteria of 1 or 2 assessed within 14 days of randomization as defined below: * mGPS of 1: CRP > 10 mg/L and albumin >= 35 g/L * mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L * No prior antineoplastic chemotherapy or anti-cancer drugs. Patients who have received neoadjuvant or adjuvant chemotherapy and who are diagnosed with loco regional recurrent or metastatic disease are not eligible * ECOG/WHO Performance Status (PS) 0 <= age <= 1 * >= 4 weeks since prior major surgery, >= 2 weeks since prior minor surgery and >= 1 week since prior radiation therapy * Measurable disease using the RECIST1.1 criteria, defined as lesions that can be measured in at least one dimension and which have not been previously irradiated. Longest diameter >= 20 mm with conventional techniques or >= 10 mm with spiral CT scan or MRI * Fertile men and women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [ie, has had menses at any time during the preceding 24 consecutive months]) must use secure contraception methods as follows: intrauterine device, double-barrier contraception, as a condom and occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/cream/suppository), vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female, or complete abstinence from sexual intercourse from before 2 months entering the study until 6 months after end of chemotherapy * Acceptable hematology parameters defined as: * Absolute neutrophil count (ANC) >= 1.5 x 10⁹/L * Platelet count >= 100 x 10⁹/L * Haemoglobin >= 5.6 mmol/L * Acceptable liver function defined as: * Serum bilirubin < 1.5 x upper limit of normal (ULN) * ASAT/ALAT < 2.5 x ULN ( < 5 x ULN with known liver metastasis) * Acceptable renal function with a creatinine clearance >= 50 mL/min/ (eg, using the Cockroft-Gault formula) * Subjects must have signed and dated a BIOPAC IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care Exclusion Criteria: * Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk of arrhythmia. * Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score <= 6, PSA < 0.5 ng/ml), or any other tumor with a disease free survival of >= 5 years. * History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to: * Active infection requiring antibiotics within 2 weeks before the study inclusion * Concurrent congestive heart failure NYHA ( class III - IV ) * Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension * Inflammatory bowel disease (colitis, Crohns) or other serious gastrointestinal conditions associated with risk of perforation * Peripheral neuropathy grade >= 2 according to CTCAE v 4.0 * Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications. * No known or suspected allergy to the investigational agents or any agents given in association with this trial. * Pregnant or lactating women. * Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up. * Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02767557

{ "NCT_ID" : "NCT02738827", "Brief_Title" : "Diode Laser Treatment of Bladder Tumors", "Official_title" : "Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department.", "Conditions" : ["Bladder Cancer"], "Interventions" : ["Procedure: Laser treatment"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Laser treatment of pTa low grade bladder tumours in the outpatient department Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark. Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation). Detailed Description Laser treatment of pTa low grade bladder tumours in the outpatient department Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark. Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation). Study Design: Open prospective study in patients with recurrent pTa low grade bladder tumours. All patients will have their bladder tumour removed using a diode laser. The treatment will take place in the outpatient department (OPD) without any pain treatment. Biopsy from the tumour will be obtained before the procedure. If the biopsy shows low grade non-invasive bladder tumour, flexible cystoscopy will be repeated one month later in the OPD. At both procedures biopsy will be taken from the laser treated area. If the per-operative biopsy shows high grade or invasive tumour, the patient will be referred for a re-resection at the operating theatre during admittance to the urology ward. The pain is valuated by a Visual Analogue Scale Score and filled out immediately after each procedure. Treatment induced symptoms will be evaluated using a QOL questionnaire which the patient fills out one week after the laser treatment and one week after the cystoscopies. Population: Patients with histologically confirmed pTa urothelial bladder tumours Number of Subjects: Twenty patients Selection of Subjects: Patients scheduled for a trans urethral resection of bladder tumour (TUR-B) less than 1,5 cm at the operating theatre under general anaesthesia and without concomitant therapy with anticoagulants as Marevan, Marcoumar, and the new anticoagulants as Pradaxa etc. will after informed consent be included in the study. Equipment: Diode laser Storz, SPIES Biopsy forceps, Storz Key Dates: Overall duration of the study: 6 months included 1 months follow up Efficacy and Safety Variables Primary Endpoint: proportion of patients where the bladder tumours are completely removed by one laser treatment. Secondary Endpoints: * Portion of general urinary problems and QOL after laser treatment compared to cystoscopy and biopsy in the OPD * Pain at the laser treatment and the cystoscopy assessed by Visual Analog Scale (VAS) Score. Statistical Methods and Planned Analysis: Non-parametric and descriptive statistics will be performed Parameters in the case report form (CRF): Bladder cancer diagnosis (pTa low grade) * Age * Sex * Mapping of lesions in normal, Clara Chrome, Spectra A and B filter cystoscopy * Histology of all suspicious lesions * SEPARATE CYSTOSCOPYFORM for laser TUR-B and the two follow up cystoscopies * The duration of the laser treatment * Expected clearance after the laser TUR-B * The visibility during the laser TUR-B * Visual Analog Scale Score result (to measure pain when laser treatment is performed and biopsies are taken in the OPD) #Intervention - PROCEDURE : Laser treatment - Intervention is diode laser treatment of bladder cancer through a cystoscope in the outpatient department

#Eligibility Criteria: Inclusion Criteria: * Recurrence of pTa low grade urothelial bladder tumor * Tumor < 1.5 cm * < 6 tumors Exclusion Criteria: * Patients with porphyria * Known hypersensitivity to Hexvix® or porphyrins * Use of any anticoagulants * Macroscopic hematuria * Pregnant or breast feeding women * Expected poor compliance * Patients < 18 years * Patients who do not read or understand Danish Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02738827

{ "NCT_ID" : "NCT00502411", "Brief_Title" : "Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma", "Official_title" : "A Phase I Study of Post-Operative Concurrent Chemoradiation for Extremity and Trunk Soft Tissue Sarcoma", "Conditions" : ["Soft Tissue Sarcoma"], "Interventions" : ["Radiation: Radiation Therapy", "Drug: Doxorubicin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this clinical research study is to learn if the combination of radiation therapy plus low dose doxorubicin chemotherapy given after surgery is effective in the treatment of sarcoma. The safety of this treatment will also be studied. Detailed Description Doxorubicin is a drug that is commonly used to treat certain kinds of cancer. The radiation treatment and chemotherapy will start around 4-6 weeks after surgery. During the study, you will receive radiation treatments 5 days a week for 6 - 61/2 weeks. On Day 1 of each week of radiation therapy, you will be given doxorubicin through a continuous injection into a vein for 4 days in a row. A special tube is placed into a large vein in the neck or chest region or through a large vein in the arm. This is called a central venous line. A small pump is then used to give the drug. This pump is about the size of a pack of cigarettes. You will receive appropriate instructions for the maintenance of the pump. The doxorubicin and radiotherapy will be given on an outpatient basis at M. D. Anderson. If the disease gets worse or you experience any intolerable side effects, chemotherapy and/or radiation therapy may be stopped and you may be taken off the study. At that time, your doctor will discuss other treatment options with you. Before the start of each week of treatment, you will have a physical exam and blood tests (around 2 tablespoons). You will also have a MRI to check on the status of the disease. After the study, you will have follow-up visits at M. D. Anderson every 3-4 months for the first 2 years after the study then every 6 months for the next 3 years. After that you will have follow-up visits once a year for the rest of your life to check on the status of the disease. At every follow-up visit you will have ultrasound scans. You will have a MRI at the first follow-up visit then only when the doctor feels it is necessary. This is an investigational study. Doxorubicin is FDA approved and is commercially available. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson. #Intervention - DRUG : Doxorubicin - 17.5 mg/m\^2 IV bolus infusion, followed by continuous IV infusion on days 1-4. - Other Names : - AD, Hydroxydaunomycin hydrochloride - RADIATION : Radiation Therapy - Radiation treatments 5 days a week for 6 - 6 1/2 weeks. 60 Gy in 6 weeks (negative resection margin) to 66 Gy in 6.5 weeks (positive resection margin). - Other Names : - XRT, RT, Radiotherapy

#Eligibility Criteria: Inclusion Criteria: * All patients with cytological or histological proof of large (> 5 cm), completely resected soft tissue sarcoma of the extremity or trunk (AJCC Stage IB, IIA, IIC, and III) will be eligible. Patients with stage IV sarcoma who are considered for primary tumor treatment with surgery and postoperative radiation are also eligible. * Patients who have undergone pre-referral surgical resection or excisional biopsy with no measurable residual disease on appropriate radiological imaging will be eligible. The adequacy of the surgical resection will be evaluated at MDACC and re-excision will be performed as necessary. Negative surgical resection margins are desirable; positive margins, however, are allowable if re-excision would result in functional deficit. * Patients may have received prior doxorubicin-based systemic chemotherapy up to a total doxorubicin dose of 450 mg/m2. Inclusion of patients with a prior history of malignancy will be at the discretion of the Study Chairman. * Patients must have a Karnofsky P.S. of > 70 or a Zubrod P.S. of 0 or 1. * Absolute neutrophil count must be > 1,500 cells/mm; platelet count > 100,000 platelets/ml; serum creatinine < 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 3 x normal, total bilirubin < 1.5 mg/dl. For patients with cumulative doxorubicin 400 - 450 mg/m2, EF > 50%. * EKG (within 6 weeks of the planned start of treatment). * Echocardiogram or multiple gated acquisition scan (MUGA) (if prior doxorubicin treatment or history of either myocardial infarction or congestive heart failure). * Patients must have no uncontrolled co-existing medical conditions. * Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception. * All patients must sign an informed consent. Exclusion Criteria: 1) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible. Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00502411

{ "NCT_ID" : "NCT00129922", "Brief_Title" : "Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer", "Official_title" : "Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Fluorouracil", "Drug: Epirubicin", "Drug: Cyclophosphamide", "Drug: paclitaxel"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence. Also, for axillary positive node patients, optimum chemotherapy regimens are still under discussion. Some previous studies suggest that, in the subset of node-positive patients, treatments based on sequential administration of anthracyclines and taxanes are more efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic index (activity/toxicity). The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8 weekly paclitaxel administrations (100mg/m2). The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The investigators expect to increase this by 8% with the experimental treatment. With an alpha error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250 patients are needed, 625 per arm. Detailed Description The primary endpoint of study-5-year disease-free survival (DFS) will be assessed by Kaplan Meier analysis. Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular markers. Associations and interactions will be assessed with a multivariable Cox proportional hazards model for DFS for the following covariates: age, menopausal status, tumor size, lymph node status, type of chemotherapy, tumor size, positive lymph nodes, HER2 status, and hormone receptor status. All statistical tests will be two-sided. #Intervention - DRUG : paclitaxel - Other Names : - Taxol - DRUG : Fluorouracil - Other Names : - 5-FU - DRUG : Epirubicin - Other Names : - 4-Epirubicin - DRUG : Cyclophosphamide

#Eligibility Criteria: Inclusion Criteria: * Written informed consent. * Histological diagnosis of breast cancer. * Node positive operable breast cancer (stages II-III). * Breast cancer surgery, consisting of radical mastectomy or conservative surgery, plus lymphadenectomy with at least 6 extirpated nodes. Surgery must have happened in the 8 weeks prior to randomisation. * Age >=18 and <= 70 years. * Negative pregnancy test. Adequate contraceptive method during the study participation. * Performance status of 90 <= age <= 100 (Karnofsky index) or ECOG <=1. * Haemoglobin >= 10 g/dl; neutrophils > 1,500/cc; platelets > 100,000/cc. * Adequate hepatic function with bilirubin, SGOT and SGPT < 1.5 x upper normal limit (UNL). * Adequate cardiac function documented by left ventricular ejection fraction (LVEF). * Adequate renal function with creatinine < 1.5 mg/dl. Exclusion Criteria: * Previous chemotherapy, hormone therapy and/or radiotherapy for breast cancer. * Bilateral breast cancer. Lobular in situ carcinoma. * Previous or current malignancies, except for basal skin carcinoma, cervical in situ carcinoma or superficial bladder carcinoma, adequately treated. * History of arrhythmias and/or congestive heart failure or cardiac blocking grade 2 <= age <= 3; history of myocardial infarction in 6 months before recruitment. * Inability for treatment and study compliance. * Pregnant or lactating women. * Active infection. * History of hypersensitivity to cremophor or cyclosporine. * Pre-existing grade 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCI CTC]). * Hormonal receptor status not determined. * Any other criteria which, in investigator's opinion, may jeopardize patient's security or compliance. * Administration of other investigational product in the 30 days prior to randomisation; current participation in another clinical trial. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00129922

{ "NCT_ID" : "NCT04812691", "Brief_Title" : "CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma", "Official_title" : "CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma, Phase Ⅰ,Open-label,Single-arm,Muticenter Study", "Conditions" : ["Diffuse Large B Cell Lymphoma"], "Interventions" : ["Biological: JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China Detailed Description This is a phase I, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory DLBCL in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect immune response after JWCAR029 treatment. One dose level of 1.0 x 10\^8 CAR+ T cells is adopted in this study. All sujects will be followed for 2 years after JWCAR029 infusion. #Intervention - BIOLOGICAL : JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells) - Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive 1 x 10\^8 CAR+T cells (JWCAR029) treatment by intravenous (IV) injection.

#Eligibility Criteria: Inclusion Criteria: * >= 18 years; * Sign on the informed consent; * Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy; * Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Adequate organ function; * Adequate vascular access for leukapheresis procedure; * Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; * Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; * Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029 Exclusion Criteria: * Subjects who have received second-line treatment or above * CD19 negative * Primary CNS lymphoma; * History of another primary malignancy that has not been in remission for at least 2 years; * Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; * Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; * Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; * Presence of acute or chronic graft-versus-host disease (GVHD); * History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; * Pregnant or nursing women; * Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; * Received CAR T-cell or other genetically-modified T-cell therapy previously. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04812691

{ "NCT_ID" : "NCT00611962", "Brief_Title" : "Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin", "Official_title" : "Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors", "Conditions" : ["Neoplasms, Germ Cell and Embryonal"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using World Health Organization/Union Internationale Contre le Cancer (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin \[hCG\], alpha fetoprotein \[AFP\]) criteria in metastatic germ cell cancer patients #Intervention - DRUG : Oxaliplatin, Paclitaxel - Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL. - Other Names : - Eloxatin®, Taxol

#Eligibility Criteria: Inclusion Criteria: * Histologically proven germ cell cancer: gonadal (including ovarian) or extragonadal, seminomatous or non seminomatous, or clinical presentation of a GCT with elevated AFP level and/or hCG level (> or =to 100 x ULN) when a biopsy was not available * Metastatic GCT patients: * Progression disease defined as > 10% increase in hCG and/or AFP markers (and/or documented progressive disease [PD]) during a platinum-based chemotherapy or less than 6 months after the last cycle (in the case of growing non seminomatous tumor, without increased markers, a histological documentation of malignant tumor was required, to exclude growing mature teratoma) * At least 1 prior line of chemotherapy containing CDDP + etoposide; (prior regimen with high dose chemotherapy and hematopoietic stem cell support was permitted) * Eastern Cooperative Oncology Group PS (ECOG PS) grade < or =to 2 * At least 1 bidimensionally measurable lesion by imaging (CT scan) of > or =to 20 mm outside an irradiated area OR significantly increased tumor markers > 2 x ULN (on > or =to 2 consecutive tests, even in the absence of measurable lesions) * Age > or =to 18 * Adequate bone marrow reserve * Neutrophil count > or =to 1500/mm3 * Platelets > or =to 100,000/mm3 * Renal function:Creatinine < 3 x ULN * Liver function:Transaminases < or =to 2.5 x ULN, total bilirubin < 1.5 x ULN (if liver metastases, transaminases < or =to 5 x ULN) * Laboratory values obtained in the week preceding study entry * Neurosensory < or =to grade 1 NCI CTC * Signed informed consent obtained prior to all study procedures Exclusion Criteria: * Concomitant high-dose steroids (except for antiemetic prophylaxis) * Pregnancy, breast-feeding or absence of contraception in sexually active patients * Prior treatment with oxaliplatin or taxanes * History of second malignancy, except for cured non melanoma skin cancer or excised in situ cervical carcinoma * Symptomatic cerebral and/or leptomeningeal metastasis (irradiated brain metastases not requiring corticosteroid treatment were allowed) * Treatment with another experimental drug or anticancer agent or participation in another clinical study within 30 days prior to study * Other serious illness or uncontrolled infection * Psychological, social or geographical situation preventing regular follow-up * Primary tumor in brain/central nervous system Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00611962

{ "NCT_ID" : "NCT01688349", "Brief_Title" : "Pattern of Gene Expression in Adipose Tissue From Patients With Cushing Syndrome", "Official_title" : "Comparative Study of Subcutaneous and Visceral Adipose Tissue in Patients Affected by Cushing Syndrome Versus 2 Controls Population", "Conditions" : ["Cushing Syndrome Related to Cortisolic Adenoma"], "Interventions" : ["Other: analyze the role of glucocorticoid in AT distribution."], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The purpose of this trial is to investigate the impact of cortisol on adipose tissue functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to visceral obesity and features of the metabolic syndrome. The aims of this study will be * to compare the pattern of gene expression between visceral and subcutaneous adipose tissue in Cushing patients requiring an adrenalectomy as cortisol adenoma treatment; * to compare these patterns of gene expression with those of two control populations:1/ healthy metabolic subjects having a partial nephrectomy, 2/obese patients with similar degree of insulin resistance. Detailed Description Cushing's syndrome is a rare disease resulting from chronic exposure to glucocorticoids (endogenous or iatrogenic) with abnormal fat distribution (lipodystrophy). Glucocorticoids regulate the functions of adipose tissue (AT) targeting adipocyte differentiation as well as anabolic, catabolic and secretory pathways of the adipocyte. However, the mechanisms by which glucocorticoids differentially disrupt the development or metabolism of AT between deep and superficial deposits remain unknown. Among the main effectors of the glucocorticoid signaling pathway, 11 beta-hydroxysteroid deshydrogenase (11beta-HSD1) , that regenerate cortisol from cortisone, is likely a key step in the biological effect of glucocorticoids in AT. Identifying these mechanisms of action of glucocorticoids on different fat depots requires the comparison with fatty deposits derived from two types of control populations: 1/ normal weight individuals without inflammatory or metabolic disorder (controls1); 2/individuals obese matched for the level of insulin resistance (controls2). Hypothesis: Excess glucocorticoids cause abnormal fat distribution via a direct effect on the various deposits of AT, leading secondarily to insulin resistance. Primary endpoint: To compare gene expression of glucocorticoid signaling between the visceral AT (VAT) of Cushing patients with that of controls1 (matched for age and sex). Secondary endpoints: 1. For patients with Cushing and controls1, to compare their respective subcutaneous AT (SCAT) and VAT for: * The expression of genes involved in differentiation and inflammation of the AT, * Morphological aspects: adipocyte size, fibrosis, inflammation, immunohistochemistry. 2. Same parameters for Cushing patients and controls2 (matched for sex, age + / -5, HOMA-R + / -1), to differentiate the specific effects of glucocorticoid from the effects of insulin resistance, 3. To compare these parameters between SCAT and VAT from Cushing patients. Methodology and experimental design: non-randomized comparative multicenter study with constitution of a biological collection. Patients will be recruited in endocrinology before adrenalectomy and controls1 in urology. They will have a preoperative assessment and sampling of perirenal AT and SCAT at surgery. Controls2 are already included in the CRC2007-P050318 and will be drawn for matching. Number of patients needed: We assume the relative gene expression of 11β-HSD1 in the VAT not exposed to glucocorticoids = 0.81 ± 0.121. Our recruitment potential of Cushing patients is 30 patients. With 30 patients per group, we will be able to detect a difference in 11β-HSD1 gene expression in the VAT of Cushing patients at least 15% higher compared to controls1. #Intervention - OTHER : analyze the role of glucocorticoid in AT distribution. - The purpose of this trial is to investigate the impact of cortisol on adipose tissue functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to visceral obesity and features of the metabolic syndrome. The aims of this study will be * to compare the pattern of gene expression between visceral and subcutaneous adipose tissue in Cushing patients requiring an adrenalectomy as cortisol adenoma treatment; * to compare these patterns of gene expression with those of two control populations:1/ healthy metabolic subjects having a partial nephrectomy, 2/obese patients with similar degree of insulin resistance.

#Eligibility Criteria: Inclusion Criteria: * Cases: Adults with Cushing's syndrome secondary to adrenal adenoma. * Controls1: Adults with normal weight: BMI <25, having partial nephrectomy * Controls2 adults with common obesity treated by bariatric surgery, BMI> 35kg/m2 Exclusion Criteria: * Diabetes, renal or hepatic impairment, pregnancy, menopause, HIV or HCV, Cushing's syndrome due to other causes than cortisol adenoma Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01688349

{ "NCT_ID" : "NCT00575523", "Brief_Title" : "Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy", "Official_title" : "Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy", "Conditions" : ["Arrhythmia", "Respiratory Arrest"], "Interventions" : ["Drug: Atropine", "Drug: Placebo"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied by clinical complications such as unconsciousness, respiratory arrest or seizure like symptoms. Study purpose is to evaluate whether the use of i.v. Atropine before starting ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized, placebo controlled, double blinded study. Atropine or saline solution will be administered intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A 6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal possibly occurring dysrhythmias. #Intervention - DRUG : Atropine - Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation. - DRUG : Placebo - 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

#Eligibility Criteria: Inclusion Criteria: * Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation Exclusion Criteria: * contraindication for the administration of atropine like * narrow angle glaucoma * mechanic stenoses of the GI-tract * clinically relevant prostatic hypertrophy * paralytic ileus * myasthenia gravis * severe cerebral sclerosis * acute lung edema * acute myocardial infarction * cardiac insufficiency * hyperthyroidism * patients with contraindication to undergo percutaneous ethanol instillation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00575523

{ "NCT_ID" : "NCT04002284", "Brief_Title" : "Anlotinib in Metastatic HER2 Negative Breast Cancer", "Official_title" : "The Efficacy and Safety of Anlotinib in Metastatic HER2 Negative Breast Cancer, a Single Arm Phase II Clinical Trial", "Conditions" : ["Breast Neoplasm", "Antineoplastic Agents", "Anlotinib"], "Interventions" : ["Drug: Anlotinib Hydrochloride"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The hypothesis of this study is to discover if the anlotinib can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer. Detailed Description Breast cancer is one of the most common malignant tumors in women, which is a serious threat to women's health. Despite the continuous improvement of treatment, 30% of breast cancer eventually develops into advanced breast cancer. The median survival of advanced breast cancer after routine treatment is 2-3 years. The main treatments include chemotherapy, endocrine therapy, and targeted therapy. The treatment of metastatic breast cancer (MBC) aims to improve quality of life, reduce pain and prolong survival. Angiogenesis plays an important role in tumor cell proliferation and metastasis. Various anti-angiogenic drugs such as bevacizumab, sunitinib, sorafenib, etc. have been developed and widely used in various tumors. Treatments such as colon cancer, lung cancer, and renal cell carcinoma significantly improve PFS and OS in patients with advanced disease, and the adverse reactions are well tolerated. However, anti-angiogenic therapy has certain limitations in the treatment of advanced breast cancer. Anrotinib hydrochloride capsule is a new drug independently developed in China. It is a multi-target receptor tyrosine kinase inhibitor targeting angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3 and other kinases such as cell growth-related kinases such as PDGFRα/β, c-Kit, and Ret , and it was approved by China Food and Drug Administation for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have progressed or relapsed after receiving at least 2 systemic chemotherapy. Basic research shows that anlotinib is effective in breast cancer cell lines, but lacks the results of clinical application of advanced breast cancer. This study is based on the results of phase I clinical trials of allerinib in a variety of advanced solid tumors, to explore its efficacy and safety in HER2-negative advanced breast cancer. #Intervention - DRUG : Anlotinib Hydrochloride - Anlotinib 12mg p.o. d1-14, 21days/cycle - Other Names : - anlotinib

#Eligibility Criteria: Inclusion Criteria: * Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; HER2 negative(immunohistochemistry or fluorescence in situ hybridization); * ECOG score: 0 <= age <= 1, expected survival time >= 3months; * Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1 <= age <= 2 standard chemotherapies after recurrence and metastasis; * According to RECIST 1.1, exist at least >=1 measurable lesion(CT >1cm，other examination >2cm); * The patients have enough organ function. The laboratory test indexes must comply with the following requirements: Blood routine: neutrophil>=1.5G/L, platelet count >=80G/L, hemoglobin >=90g/L Liver function: serum bilirubin <= 1.5 times the upper limit of normal value; ALT and AST<=2.5 times the upper limit of normal value; ALT and AST<=5 times the upper limit of normal value when liver metastasis Renal function: serum creatinine <= 1.0times the upper limit of normal value, creatinine clearance >50ml/min（Cockcroft-Gault formula) * Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial and 8 weeks after last administration； * Can swallow oral drugs; * The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form. Exclusion Criteria: * The patients in pregnancy or lactation growth period and did not take effective contraception; * The patients who received >=3 chemotherapies（Do not include endocrine therapy）after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study; * The patients with a variety of factors that affect the oral administration and absorption of drugs; * The patients with rapid progression of viscera invasion(liver lesion >1/2 viscera area or liver dysfunction); * The patients have uncontrollable mental illness. * The patients who had serious adverse effect to oral etoposide or were allergic to etoposide. * The patients who have only bone metastasis without other measurable lesion; * The patients experience severe cardiovascular diseases; * The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome. * Abnormal bone marrow functions(neutrophil<1.5G/L, platelet count <75G/L, hemoglobin <90g/L); * Abnormal renal function(serum creatinine > 1.5 times the upper limit of normal value); * Abnormal liver function(serum bilirubin <= 1.5 times the upper limit of normal value); * The patients have uncontrollable brain metastasis; * The patients do not have good compliance to the therapy. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04002284

{ "NCT_ID" : "NCT03636568", "Brief_Title" : "Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)", "Official_title" : "Early Fluid Restriction to Prevent Delayed Hyponatremia Following Pituitary Surgery", "Conditions" : ["Hyponatremia", "Hyponatremic", "Pituitary Tumor", "Pituitary", "Surgery"], "Interventions" : ["Other: Fluid Restricted Group"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Hyponatremia is defined as sodium below the normal range of 135-145. Symptomatically, it can cause patients to experience a wide range of symptoms including lethargy, headache, nausea, vomiting and in severe cases coma and even death. The goal of this study is to prospectively compare two approaches to the postoperative fluid management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst to decrease the occurrence of postoperative delayed hyponatremia. One group will be placed on moderate fluid restriction and the other group will be placed on ad lib fluid intake. Detailed Description Any adult patient with a pituitary adenoma (either non-functioning, prolactin-secreting, growth hormone secreting, gonadotropin secreting, or TSH (thyroid stimulating hormone) secreting) or cyst scheduled to undergo transsphenoidal resection will be included in the study. Patients with chronic hyponatremia will be excluded. Patients will be randomly assigned to one of two groups: Group 1: these patients will be treated with moderate fluid restriction (1000 ml/24 hours for patients \<100kg and 1200 ml of fluid/24 hours for \>100 kg starting on postoperative day 1. Fluid restriction will be aborted if diabetes insipidus occurs. Diabetes insipidus occurs if a patient does not produce enough ADH (anti-diuretic hormone) which is needed to concentrate the urine. Diabetes insipidus causes increased urination and increased thirst and can cause hypernatremia (an increased sodium level). A person will be diagnosed with diabetes insipidus if they meet all of the following criteria: serum sodium level \> 146, dilute urine with a urine specific gravity \< 1.003 and increased urine output defined by urine output \> 300cc/hour for 2 consecutive hours( or \> 6 liter/24 hours). Group 2: these patients will not be placed on fluid restriction, they will be allowed to drink water freely after surgery. All patients will be started on D5 ½ normal saline IV fluids (Weight based) and will be allowed to eat and drink starting on POD 1. All the patients will receive a thirst questionnaire that will be completed daily starting on POD 1 until POD 13. The intensity of thirst will be assessed on a scale of 1--10, with 1 being no thirst, 5 being normal thirst and 10 being unbearable thirst. Patients will have basic metabolic panels checked on post-surgical days 1, 3, 7, 10 and 13. #Intervention - OTHER : Fluid Restricted Group - Patients will be started on a weight-based intravenous fluid replacement with D5 ½ NS on POD 0 (75 cc/hr for patients \< 70kg, 100 cc/hr for patients 70-100kg, and 125 cc/hr for patients \>100kg). Patients will be allowed to drink water freely after surgery on POD #0. Fluids will be stopped at 8am on POD 1 and patients will be started on a moderate fluid restriction on POD #3 based on their weight (1000 cc/24 hours for patients who weigh \<=100 kg and 1200 cc/24 hours for patients who weigh \> 100kg). Prior to initiation of a fluid restriction all of the following criteria have to be met: 1. Serum Na level must be \< 145 mEq/l 2. Patient should be taking fluids by mouth 3. Patient should not have evidence of DI (as determined by endocrine team following patient) If a patient in Fluid Restricted group develops DI, the fluid restriction will be stopped/not initiated.

#Eligibility Criteria: Inclusion Criteria: * Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin-secreting, growth hormone secreting, ACTH (adrenocorticotropic hormone)-secreting, gonadotropin secreting, or TSH secreting) scheduled to undergo pituitary resection. Exclusion Criteria: * Patients with a history of chronic hyponatremia * Patients with a history of SIADH (syndrome of inappropriate antidiuretic hormone) , except if secondary to hypothyroidism or adrenal insufficiency, or in association with prior TSS * Patients with diabetes insipidus or patients receiving DDAVP * Patients without an intact thirst mechanism * Patients with CKD (chronic kidney disease) stage III, IV or V * Patients with untreated adrenal insufficiency or hypothyroidism * Patients with class III or IV heart failure Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03636568

{ "NCT_ID" : "NCT00947856", "Brief_Title" : "A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study", "Official_title" : "Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study", "Conditions" : ["Disease, Hodgkin", "Lymphoma, Large-Cell, Anaplastic", "Lymphoma, Non-Hodgkin"], "Interventions" : ["Drug: brentuximab vedotin"], "Location_Countries" : ["France", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study. Detailed Description This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows: * Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin. * Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting. #Intervention - DRUG : brentuximab vedotin - Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure - Other Names : - Adcetris

#Eligibility Criteria: Inclusion Criteria: * Participated in a previous brentuximab vedotin study. * CD30-positive hematologic malignancy. * At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study. Exclusion Criteria: Withdrew consent to participate in any prior brentuximab vedotin study. Sex : ALL Ages : - Minimum Age : 6 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00947856

{ "NCT_ID" : "NCT01681537", "Brief_Title" : "Lenalidomide Plus Chemotherapy for AML", "Official_title" : "A Phase I Study of Lenalidomide Plus Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine for the Reinduction of Patients With Acute Myelogenous Leukemia", "Conditions" : ["Acute Myelogenous Leukemia"], "Interventions" : ["Drug: Cytarabine", "Drug: Lenalidomide", "Drug: Mitoxantrone", "Drug: Etoposide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination of drugs to use for further studies. 'Investigational' means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this combination of drugs for AML. As part of this research study, you will take lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered investigational in this research study because it is not approved by the FDA for patients with AML. Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or IMID. This drug is successful in the treatment of patients with multiple myeloma and some patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that lenalidomide may also be effective in patients with AML. Since we know that many patients who receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia), we are studying the addition of lenalidomide to MEC. In this research study, we are looking for the highest dose of lenalidomide that can be given safely with MEC. Detailed Description After undergoing screening procedures to confirm that you are eligible to participate in the research study you will be admitted to the hospital. You will likely receive the majority of treatment on an inpatient basis. You will remain in the hospital for at least Days 4-8 and will be discharged at the discretion of your study doctor. It is likely that you will be hospitalized for several weeks due to the risk of infection after chemotherapy. Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have relapsed or refractory AML, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. If you take part in this study you will be given a study drug-dosing calendar. There is only one cycle of treatment, which will be 28 days long. On Days 1 to 14 you will receive the lenalidomide orally. On Days 4-8 you will receive MEC chemotherapy: mitoxantrone by IV (intravenously, into your vein) over 30 minutes, etoposide by IV over one hour, and cytarabine by IV over one hour. While on this study you will undergo a daily clinical exam for the first 14 days and then at least twice a week until your blood counts recover from treatment. A clinical exam consists of a physical exam, questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. You will also undergo blood tests to assess your disease status and determine organ function level. This will happen daily for the first 14 days and then at least once a week (but up to 3 times per week) until your blood counts recover from treatment. Additionally a bone marrow aspirate/biopsy will be completed at the time of blood cell count recovery (usually between days 20 and 45) and as clinically indicated. We would like to keep track of your medical condition for up to two years after your final dose of study drug. We would like to do this by getting in touch with you every 6 months to see how you are doing. Keeping in touch with you and checking your condition helps us look at the long-term effects fo the research study. #Intervention - DRUG : Lenalidomide - DRUG : Mitoxantrone - DRUG : Etoposide - DRUG : Cytarabine

#Eligibility Criteria: Inclusion Criteria: * Primary refractory disease following at least one cycle of induction therapy or first relapse or higher * Must be registered into RevAssist program * Able and willing to adhere to study schedule and other protocol requirements Exclusion Criteria: * Pregnant or breastfeeding * Known hypersensitivity to thalidomide or lenalidomide * Known seropositive for HIV * Have had myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure * Other serious medical conditions or psychiatric conditions * Major surgery within 28 days prior to treatment * Received investigational agent or cytotoxic chemotherapy (except hydroxyurea) within 2 weeks of study * Acute promyelocytic leukemia Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01681537

{ "NCT_ID" : "NCT01148446", "Brief_Title" : "R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL", "Official_title" : "A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL)", "Conditions" : ["Elderly Patients (>65 Years)", "Diffuse Large B Cell Lymphoma (DLBCL)"], "Interventions" : ["Drug: Vincristine", "Drug: Vinblastine", "Drug: G-CSF", "Drug: Rituximab", "Drug: Doxorubicin", "Drug: Prednisone", "Drug: Epirubicin", "Drug: Cyclophosphamide"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (\>65 years) with Diffuse Large B Cell Lymphoma (DLBCL). #Intervention - DRUG : Cyclophosphamide - 750 mg/mq IV, day 1 - DRUG : Cyclophosphamide - 50 mg/mq IV, day 1 - DRUG : Doxorubicin - 50 mg/mq IV, day1 - DRUG : Vincristine - 1,4 mg/mq (max 2 mg)IV, day 1 - DRUG : Prednisone - 75 mg/mq IV, days 1-5 - DRUG : Prednisone - 60 mg/mq IV/PO, days 1-5 - DRUG : Epirubicin - 50 mg/mq IV, day 1 - DRUG : Vinblastine - 5 mg/mq IV, day 1 - DRUG : Rituximab - 375 mg/mq IV, day 1 - DRUG : G-CSF - 300 µg tot., SC; days 7-11

#Eligibility Criteria: Inclusion Criteria: * Patients with untreated DLBCL aged 66 <= age <= 80 without major accompanying diseases and considered as 'non frail'. * Patients were classified as 'non frail' (fit) if they had * ADL (Activity of Daily Living) score of 6 * less than three grade 3 Cumulative Illness Rating Score for Geriatrics (CIRS-G) co-morbidities and no grade 4 co-morbidities * absence of geriatric syndrome * Patients HIV negativity; * Concurrent malignancy; * Written Informed Consent. Exclusion Criteria: * All other patients were classified as 'unfit', and were excluded from randomization Sex : ALL Ages : - Minimum Age : 66 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No

NCT01148446

{ "NCT_ID" : "NCT00335179", "Brief_Title" : "Cellular and Molecular Events During Treatment of Actinic Keratosis With Imiquimod 5% Cream", "Official_title" : "Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%", "Conditions" : ["Actinic Keratosis"], "Interventions" : ["Drug: Aldara (imiquimod 5% cream)", "Drug: Vehicle cream"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes. Detailed Description The primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis (AK) lesions that were treated with imiquimod 5% cream or vehicle cream once daily 3 times per week for 4 weeks. Secondary objectives were to assess the utility of confocal microscopy (CM) to visually track cellular response to treatment with study cream compared with clinical and histological evaluations, and to evaluate the safety of treatment with imiquimod in subjects with AK on the balding scalp. #Intervention - DRUG : Aldara (imiquimod 5% cream) - Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream - Other Names : - imiquimod cream - DRUG : Vehicle cream - Vehicle cream in 250 mg - Other Names : - placebo cream

#Eligibility Criteria: Inclusion Criteria: * Have actinic keratoses on balding scalp * Discontinuation of tanning bed use * Discontinuation of moisturizers * Avoidance of retinol products Exclusion Criteria: * Uncontrolled, clinically significant medical condition * Dermatologic disease other than actinic keratosis in treatment area Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00335179

{ "NCT_ID" : "NCT05046951", "Brief_Title" : "Educating QUitline Callers About Lung Cancer Screening", "Official_title" : "Testing Methods to Increase Lung Cancer Screening Among Quitline Callers", "Conditions" : ["Population at Risk"], "Interventions" : ["Behavioral: Should I Screen website", "Behavioral: Should I Screen print booklet"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "SCREENING", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The specific aims are: 1. To evaluate the potential barriers of providing educational lung screening interventions to quitline users, the investigators will seek input from 10-20 stakeholders on the newly adapted print version of the Should I Screen website, and on our proposed Aim 2 recruitment and retention procedures. 2. To conduct a randomized intervention, comparing: 1) ShouldIScreen.com website, (WEB; N=150); vs. 2) the Should I Screen print version (PRINT; N=150). H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intention to undergo lung screening, compared to PRINT. Randomization will be stratified by age and pack-years in order to incorporate those who are recently eligible for screening, ages 50-54 and with 20-29 pack years. H2.2 The investigators will explore several potential moderators (age and e-health literacy). For example, the investigators will explore whether older vs younger participants have differential knowledge outcomes when using the PRINT vs WEB interventions. H2.3 We will explore whether mediators (prior lung screening, current primary care provider, lung cancer perceived risk) positively affects knowledge and screening intentions. 3. To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., method of quitline access, age, e-health literacy). Detailed Description Aim 1: The 30-45 minute qualitative interviews will obtain: 1) feedback on the print adaptation of the Should I Screen website (the investigators will send it in advance of the interview), 2) recommendations for effective recruitment and retention procedures in Aim 2, 3) feedback on methods to increase the likelihood that participants will enroll and engage with the interventions (e.g., whether to present the study information immediately following initial contact with the quitline or later), 4) ideas to increase the likelihood that participants will contact their providers for an appointment to discuss lung screening, and 5) feedback on the Aim 2 measures regarding feasibility and acceptability. Aim 2: H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intentions to undergo lung screening, compared to PRINT. H2.2 Moderators include, age, e-health literacy. For example, the investigators expect that younger participants will have significantly increased knowledge in the WEB (vs PRINT) arm, whereas intervention arm will have less of an impact among the older participants. H2.3 Mediators (e.g., prior lung screening, current primary care provider, lung cancer perceived risk) will positively affect knowledge and screening intentions. Aim 3. To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., age, e-health literacy). The investigators will assess the feasibility for widespread implementation of both interventions #Intervention - BEHAVIORAL : Should I Screen website - The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening. - BEHAVIORAL : Should I Screen print booklet - The Should I Screen print-based education will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.

#Eligibility Criteria: Inclusion Criteria: * enrolled in the quitline * 50 <= age <= 80 years * >20-pack year smoking history * never screened or >12 months since prior screen * English speaking * able to provide meaningful consent * no family members in the same household enrolled in the trial Exclusion Criterion: * prior lung cancer Sex : ALL Ages : - Minimum Age : 50 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT05046951

{ "NCT_ID" : "NCT01905657", "Brief_Title" : "Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)", "Official_title" : "A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer", "Conditions" : ["Non Small Cell Lung Cancer (NSCLC)"], "Interventions" : ["Drug: Docetaxel", "Biological: Pembrolizumab"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m\^2 Q3W. The total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis. Eligible participants who were allocated to the first course of pembrolizumab (2 mg/kg Q3W or 10 mg/kg Q3W) and experienced disease progression, to be permitted to receive a second course of pembrolizumab as long as Inclusion/Exclusion criteria were met. Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel and experienced disease progression, to be permitted to switch over to receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met. With Protocol Amendment 15 (effective date: 03 Jan 2018), all second course and switch over participants will receive pembrolizumab 200 mg Q3W. Response or progression during the second and switch over pembrolizumab courses will not count towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses will not count towards safety outcome measures. Also with Amendment 15, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment. Switch over participants who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis. The primary study hypotheses are that pembolizumab prolongs Overall Survival (OS) and Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by independent radiologists' review in previously-treated participants with NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and in participants whose tumors express PD-L1 compared to docetaxel. #Intervention - BIOLOGICAL : Pembrolizumab - IV infusion - Other Names : - MK-3475, KEYTRUDA® - DRUG : Docetaxel - IV infusion - Other Names : - TAXOTERE®

#Eligibility Criteria: Inclusion Criteria: * Life expectancy of at least 3 months * Histologically- or cytologically-confirmed diagnosis of NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive per central laboratory review * At least one bi-dimensional measurable lesion * Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: * Prior therapy with docetaxel for NSCLC * Receiving systemic steroid therapy within 3 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication * Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose * Expected to require any other form of systemic or localized antineoplastic therapy while on trial * History of allogeneic tissue/solid organ transplant * Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of >30 Gy within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug * Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), or took part in another pembrolizumab trial * Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents * Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment * Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01905657

{ "NCT_ID" : "NCT01852591", "Brief_Title" : "Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant", "Official_title" : "Exploration of Immune Response to Pneumococcal Conjugate Vaccine (PCV13) Administered Before and Early After Autologous Peripheral Stem Cell Transplant (Auto-PSCT) in Patients With Multiple Myeloma", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Biological: PCV 13"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response. Detailed Description This is a pilot study to determine the safety of PCV13 administered to patients with myeloma before and at +7-10 days and +21-24 days after autologous hematopoietic stem cell transplant; and,to quantify the immune response induced by PCV13 vaccination in patients with myeloma when administered before and early after autologous PSCT. #Intervention - BIOLOGICAL : PCV 13 - Other Names : - Prevnar, pneumococcal conjugate vaccine

#Eligibility Criteria: Inclusion Criteria: * Patients with confirmed multiple myeloma * Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant Exclusion Criteria: * Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine * HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing * Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome * Active central nervous system (CNS) malignancy * Prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy. * History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine. * Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation * Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician * Active or uncontrolled infection * Diffusing lung capacity oxygenation (DLCO) <50 % * Left ventricular ejection fraction (LVEF) <40% * Bilirubin >2 Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01852591

{ "NCT_ID" : "NCT01897038", "Brief_Title" : "A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma", "Official_title" : "A Phase Ib, Open-Label Study Evaluating The Safety, Tolerability, and Pharmacokinetics of Onartuzumab Given as a Single Agent and in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)", "Conditions" : ["Carcinoma, Hepatocellular"], "Interventions" : ["Drug: Onartuzumab", "Drug: Sorafenib"], "Location_Countries" : ["Singapore", "Hong Kong", "Taiwan", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3 will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg orally daily or twice daily. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. #Intervention - DRUG : Onartuzumab - Onartuzumab intravenous infusion at a starting dose of 10 or 15 milligram per kilogram body weight administered every 3 weeks (Q3W) until disease progression or unacceptable toxicity occurs (maximum up to 31 months). - Other Names : - RO5490258 - DRUG : Sorafenib - Sorafenib 400 milligram (mg) tablets (2 tablets of 200 mg each) orally once daily or twice daily depending on the cohort assigned until disease progression or unacceptable toxicity occurs (maximum up to 31 months).

#Eligibility Criteria: Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Cytologically or histologically confirmed diagnosis of hepatocellular carcinoma (HCC) * Advanced or metastatic disease * Not a candidate for curative treatments (that is, resection, transplantation) * Child-Pugh class A liver function * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Life expectancy greater than (>) 3 months * For participants who received prior adjuvant chemotherapy, a treatment-free interval of at least 6 months between the last chemotherapy cycle and Cycle 1 Day 1 Exclusion Criteria: * Prior surgery or local therapy within 4 weeks prior to Cycle 1 Day 1, with the exception of palliative radiation therapy to the bone * Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation * Granulocyte count less than (<) 1500 per cubic millimeter (mm^3), platelet count < 75,000/mm^3, and hemoglobin < 8 gram per deciliter (g/dL) within 7 days prior to Cycle 1 Day 1 * Total bilirubin greater than (>) 1.5 times the upper limit of normal (ULN) * Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), Alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase (ALP) > 5 × ULN * Serum creatinine > 1.5 × ULN or creatinine clearance < 60 cubic centimeter per minute (cc/min) by Cockcroft-Gault formula * Significant history of cardiac disease within 6 months prior to Cycle 1 Day 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication * Serious active infection, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment, with the exception of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections * Known active infection with human immunodeficiency virus (HIV) or known HIV-seropositivity * Inability to take oral medication or untreated malabsorption syndrome * Pregnant or lactating women * History of transplantation including organ, bone marrow transplantation, and peripheral blood stem cell transplantation with the exception of corneal transplantation * Active bleeding diathesis (including active esophageal varices) or tumor rupture within 8 weeks prior to Cycle 1 Day1 that are not successfully treated * Uncontrolled hypertension * Treatment with any other investigational drug within 4 weeks of Cycle 1 Day Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01897038

{ "NCT_ID" : "NCT00262678", "Brief_Title" : "Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain in Cancer Patients.", "Official_title" : "A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients.", "Conditions" : ["Pain", "Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients. #Intervention - DRUG : EN3267

#Eligibility Criteria: Inclusion Criteria: * Males or females 17 years or older * Stable cancer-related pain. * Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain for at least 14 days prior to screening. * Experiencing 1 <= age <= 4 episodes of breakthrough pain per day. * Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2. Exclusion Criteria: * Are pregnant or lactating. * Have uncontrolled or rapidly escalating pain. * Have moderate to severe ulcerative mucositis. * Have a cardiopulmonary disease that would increase the risk of administering potent opioids. * Have neurologic or psychologic disease that would compromise data collection * Have any clinically significant condition that would, in the investigator's opinion, preclude study participation. * Are currently taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study. * Have received strontium 89 therapy within 60 days prior to entering the study. * Have received anti-neoplastic therapy within 2 weeks of study entry that, in the investigator's opinion, will influence assessment of breakthrough pain * Have received any investigational drug (non-approved) within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than EN3267 during the course of the study. * Have hypersensitivities, allergies, or contraindications to fentanyl. * Have a significant prior history of substance abuse or alcohol abuse. * May have difficulty complying with the protocol, as assessed by the investigator. Sex : ALL Ages : - Minimum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00262678

{ "NCT_ID" : "NCT01584531", "Brief_Title" : "Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome", "Official_title" : "A Phase II, Multicenter, Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent Low or Intermediate-1 (Any Cytogenetics) or Trisomy 8 Intermediate-2 Myelodysplastic Syndrome Patients Based on IPSS Classification", "Conditions" : ["Myelodysplastic Syndrome", "MDS", "Trisomy 8"], "Interventions" : ["Drug: rigosertib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The primary objectives of this study are to determine if rigosertib sodium, given orally in the form of soft gel capsules, is safe and is associated with a reduction in the number of blood transfusion units that are needed in patients with myelodysplastic syndrome (MDS) classified as Low or Intermediate-1 (Int-1) (any cytogenetics) or trisomy 8 Intermediate 2 (Int-2) in the International Prognostic Scoring System (IPSS) who are transfusion-dependent. Rigosertib will be taken on days 1 to 21 of a 21-day cycle. Detailed Description This will be a Phase II open-label, multicenter (up to 5 centers), single-arm study. Sixty transfusion-dependent patients with MDS classified as Low or Int-1 risk (any cytogenetics) or trisomy 8 Int-2 by International Prognostic Scoring System (IPSS) will be enrolled to receive rigosertib BID for 21 consecutive days of a 21-day cycle. Patients will be stratified on prior treatment with azacitidine and/or decitabine and/or lenalidomide and/or erythropoietin. Patients will remain treated on study until 2006 Internation Working Group (IWG) progression criteria are met or until death from any cause. All study participants will be allowed, as medically justified, access to RBC and platelet transfusions, and to filgrastim \[G-CSF\]. Erythropoiesis-stimulating agents (ESAs) will not be allowed during the initial 3 cycles. Rigosertib dosing adjustment policies are described in Protocol. #Intervention - DRUG : rigosertib - Rigosertib sodium will be available as soft gel capsules in strengths of 280 mg and 70 mg. Rigosertib will be administered on an outpatient basis. Patients will take a 560 mg dose (e.g., 2 x 280 mg capsules) of oral rigosertib in the morning and 280 mg dose (e.g., 1 x 280 mg capsules) of oral rigosertib every day of 21-day cycles. Rigosertib should be taken in a fasting state (defined by at least 30 minutes before next meal) BID at 12 hr intervals (with a window of 2 hr). Any vomited dose will be reported as a missed dose. The patient will fill a diary indicating the day and time of drug intake. - Other Names : - rigosertib sodium, ON 01910.Na, oral rigosertib

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of MDS confirmed by bone marrow aspirate and/or biopsy within 6 weeks prior to first dose of study drug according to World Health Organization (WHO) or French-American-British (FAB) classification * MDS classified as Low risk or Int-1 risk (any cytogenetics) or Trisomy 8 Int-2 risk, according to IPSS classification * Transfusion dependency defined by at least 4 units of RBC administered within 8 weeks before baseline * Off all other treatments for MDS (azacitidine, decitabine, lenalidomide, chemotherapy, immunosuppressive agents) for at least 4 weeks * ECOG performance status of 0, 1 or 2 Exclusion Criteria: * Ongoing clinically significant anemia due to factors such as iron, B12, or folate deficiencies, auto-immune or hereditary hemolysis, or gastrointestinal (GI) bleeding, unless stabilized for 1 week after RBC transfusion * Serum ferritin <50 ng/mL * Hypoplastic MDS (cellularity <10%) * Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * Active infection not adequately responding to appropriate therapy * Total bilirubin >=1.5 mg/dL not related to hemolysis or Gilbert's disease * ALT/AST >=2.5 x upper limit of normal (ULN) * Serum creatinine >=2.0 mg/dL * Ascites requiring active medical management including paracentesis * Hyponatremia (defined as serum sodium value of <130 mEq/L) * Female patients who are pregnant or lactating * Patients who are unwilling to follow strict contraception requirements * Female patients with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin (bHCG) pregnancy test at Screening * Major surgery without full recovery or major surgery within 3 weeks of rigosertib treatment start * Uncontrolled hypertension (defined as a systolic pressure >=160 mmHg and/or a diastolic pressure >=110 mmHg) * New onset seizures (within 3 months prior to the first dose of rigosertib) or poorly controlled seizures * Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy * Chronic use (>2 weeks) of corticosteroids (>10 mg/24 hr equivalent prednisone) within 4 weeks of starting rigosertib * Investigational therapy within 4 weeks of starting rigosertib * Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01584531

{ "NCT_ID" : "NCT03484702", "Brief_Title" : "Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma", "Official_title" : "A Phase 2, Single-arm, Multi-center Trial to Determine the Efficacy and Safety of JCAR017 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or With Other Aggressive B-Cell Malignancies", "Conditions" : ["Lymphoma, Non-Hodgkin"], "Interventions" : ["Drug: JCAR017"], "Location_Countries" : ["Austria", "Netherlands", "Belgium", "Italy", "Germany", "United Kingdom", "Finland", "France", "Spain", "Switzerland", "Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL) Detailed Description This is a study to determine the efficacy and safety of JCAR017 in adult participants with aggressive B-cell NHL. The study will enroll participants in Europe and Japan with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS; de novo or transformed follicular lymphoma \[tFL\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (HGBL), follicular lymphoma Grade 3B (FL3B), and primary central nervous system lymphoma (PCNSL). Participants with secondary central nervous system (CNS) involvement are allowed. Once enrolled, participants will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants will receive lymphodepleting chemotherapy followed by infusion of JCAR017. JCAR017 will be administered by intravenous infusion. Participants will be followed for approximately 2 years after their JCAR017 infusion for safety, disease status, survival and health-related quality of life. Delayed adverse events following exposure to gene modified T cells will be assessed and long-term persistence of these modified T cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after JCAR017 infusion as per competent authority guidelines. #Intervention - DRUG : JCAR017 - Specified dose on specified days - Other Names : - Lisocabtagene Maraleucel (liso-cel)

#Eligibility Criteria: Inclusion Criteria: * Histological confirmation of diagnosis at last relapse * Adequate organ function * Adequate vascular access for leukapheresis procedure Exclusion Criteria: * Prior history of malignancies, other than aggressive relapsed/refractory Non-Hodgkin Lymphoma, unless the participant has been in remission for >= 2 years with the exception of non-invasive malignancies * Received previous CD19-targeted therapy * Progressive vascular tumor invasion, thrombosis, or embolism Other protocol-defined inclusion/exclusion criteria apply Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03484702

{ "NCT_ID" : "NCT01629615", "Brief_Title" : "A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer", "Official_title" : "A Phase II Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: BKM120"], "Location_Countries" : ["Spain", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the clinical activity of BKM120 in patients with metastatic triple-negative breast cancer. Detailed Description This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory study of single agent BKM120 in the treatment of metastatic triple negative breast cancer patients. Patients will first undergo screening, tumor measurement and collection of available tumor block from the primary tumor and/or a metastatic site. Available tumor block is required in all patients per inclusion criteria. Analysis of this tumor block will be used for correlation of predictive markers and clinical response in order to define potential subpopulation that benefit from BKM120. Following confirmation of eligibility criteria, subjects will be enrolled. BKM120 will then be administered in a 100mg dose, orally, once daily, in a continuous schedule. A treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations. Treatment with BKM120 will continue until disease progression, unacceptable toxicity that precludes any further treatment, and/or discontinuation of the treatment by investigator or patient decision. #Intervention - DRUG : BKM120 - BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression

#Eligibility Criteria: Inclusion Criteria: * Pathologically and radiologically confirmed metastatic TNBC (Stage IV disease), previously documented by histological analysis, which is ER-negative and PR-negative by IHC and HER2 negative by IHC or FISH/CISH. * Subjects must have received maximum two prior chemotherapy regimens for metastatic breast cancer. * Availability of a representative tumor specimen (primary or metastasis, archival tissue or fresh biopsy for patients with biopsiable tumor) at baseline. * At least one measurable lesion by RECIST 1.1 * Age >= 18 years at the day of consenting to the study * ECOG performance status <= 2 * Adequate bone marrow and organ function as defined by the following laboratory values: ANC >= 1.0 x 109/L, platelets >= 100 x 109/L, hemoglobin >= 9.0 g/dL, INR <= 2; serum potassium between 3.0mmol/L and 5.5 mmol/L; Corrected serum calcium between8.0mg/dL and 11.5mg/dL (OR between 1.0mmol/L and 1.5mmol/L of Ionized calcium); serum magnesium between 1.2mg/dL and 3.0 mg/dL; serum creatinine <= 1.5 x ULN, ALT and AST within normal range (or <= 3.0 x ULN if liver metastases are present); serum bilirubin within normal range (or <= 1.5 x ULN if liver metastases are present; or total bilirubin <= 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome); fasting plasma glucose (FPG) <= 140 mg/dL or <= 7.8 mmol/L. Exclusion Criteria: * Previous treatment with PI3K inhibitors * Symptomatic CNS metastases * Patients with controlled and asymptomatic CNS metastases may participate in this trial. As such, the patient must have completed any prior treatment for CNS metastases > 28 days (including radiotherapy and/or surgery) prior to enrollment in this study. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment are eligible * Concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer). An exception to this rule are those patients with documented germline mutations in BRCA1 or 2, who may have previous history of cancer * Any of the following mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of >= 10 in the PHQ-9 or a cut-off of >= 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9) 1. Patients with a history or active episodes of major depression, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, history of suicide attempts or suicidal thoughts (eg. Risk of hurting or harming others) or patients with severe personality disorders (as defined by the DSM-IV) are not eligible. Note: For patients who are treated with psychotropic drugs at baseline, the dose and schedule shall not be changed during the 6 weeks prior to initiation of treatment with the study drug. 2. >= CTCAE v 4.0 grade 3 anxiety * Patients on concurrent use of other approved or investigational antineoplastic and / or chemotherapy or any continuous or intermittent treatment with therapeutic agents of low molecular weight (excluding monoclonal antibodies) in <= 21 days prior to enrollment in this study or who have not recovered from the effects such therapy will not be eligible. * Radiotherapy <= 28 days prior to enrollment in this study or failure to recover from side effects of such therapy at the time of initiation of screening procedures. * Major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery * Poorly controlled diabetes mellitus (HbA1c > 8%) * Active cardiac disease including any of the following: 1. Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)Note: ECHO/MUGA is only required at baseline if patient has a history of abnormal cardiac test results 2. QTc > 480 msec on screening ECG (using the QTcF formula 3. Angina pectoris that requires the use of anti-anginal medication 4. Ventricular arrhythmias except for benign premature ventricular contractions 5. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication 6. Conduction abnormality requiring a pacemaker 7. Valvular disease with documented compromise in cardiac function 8. Symptomatic pericarditis * History of cardiac dysfunction including any of the following; 1. Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function 2. History of documented congestive heart failure (New York Heart Association functional classification III-IV) 3. Documented cardiomyopathy * Treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) * Chronic treatment with steroids or another immunosuppressive agent. Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) are allowed. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment (e.g., dexamethasone 2 mg/day, prednisone 10 mg/day) for at least 14 days before start of study treatment, are eligible * Other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g., chronic pancreatitis, active chronic hepatitis etc.) * History of non-compliance to medical regimen * Current treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug * Known history of HIV (testing not mandatory) infection * Pregnant or nursing (lactating) woman * Woman of child-bearing potential unwilling to observe total sexual abstinence or to use a double barrier method for birth control throughout the trial. Reliable contraception should be maintained throughout the study and for 6 months after study drug discontinuation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01629615

{ "NCT_ID" : "NCT00605397", "Brief_Title" : "PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer", "Official_title" : "Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Radiation: PET Imaging With Cu-64 Labeled Trastuzumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive In this study the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin™). By giving you this tracer after you have treatment with trastuzumab (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor sites the Herceptin goes to. This will help us to understand better how Herceptin works in the body to fight cancer. #Intervention - RADIATION : PET Imaging With Cu-64 Labeled Trastuzumab - The first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease. - RADIATION : PET Imaging With Cu-64 Labeled Trastuzumab - The remaining 20 patients will undergo one PET study.

#Eligibility Criteria: Inclusion Criteria: * Registered patient at MSKCC * Age >=18 years * Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH)) * Measurable or evaluable disease * Currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care * Karnofsky Performance Score >= 60 * Signed informed consent Exclusion Criteria: * Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy * Claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure. * Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material. * Inability to provide written informed consent. * Patients with liver metastases as the only site of distant disease * Patients with known sensitivity or contraindication to Herceptin. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00605397

{ "NCT_ID" : "NCT00746317", "Brief_Title" : "A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)", "Official_title" : "A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)", "Conditions" : ["Advanced or Metastatic HCC"], "Interventions" : ["Drug: GC33"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer. Detailed Description This is a Phase I open-label dose escalation study of GC33 in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary assessment of anti-tumor activity. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established. #Intervention - DRUG : GC33 - IV administration at 4 escalating dose levels.

#Eligibility Criteria: Inclusion Criteria: * Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form * Male or female >= 18 years. * Life expectancy >= 3 months. * ECOG Performance Status of 0 <= age <= 1. * Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype). * Not a candidate for curative treatments. * Child-Pugh A or B. * Hematological, Biochemical and Organ Function: * AST (SGOT): <= 5.0 × ULN * ALT (SGPT): <= 5.0 × ULN * Total Bilirubin: <= 3.0 × ULN * Platelets: >= 50,000/μL * Absolute Neutrophil Count: >= 1,500/μL * Serum creatinine: <= 2.0 × ULN * PT-INR: <= 2.0, * Ability to provide a tumor tissue sample either by: * a sample obtained within 3 months prior to informed consent for HCC diagnosis. Resection samples are not acceptable. * undergo a biopsy to confirm HCC diagnosis * At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria. (Extension Phase) * Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form. * Male or female >= 18 years. * Life expectancy >= 3 months. * ECOG Performance Status of 0 <= age <= 1. * Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype). * Not a candidate for curative treatments. * Child-Pugh A. * Hematological, Biochemical and Organ Function: * AST (SGOT): <= 5.0 × ULN * ALT (SGPT): <= 5.0 × ULN * Total Bilirubin: <= 3.0 × ULN * Platelets: >= 50,000/μL * Absolute Neutrophil Count: >= 1,500/μL * Serum creatinine: <= 2.0 × ULN * PT-INR: <= 2.0 * IHC confirmed GPC3-positive HCC tumor tissue. Tumor tissue sample may be provided by: * A formalin fixed paraffin embedded block sample within 12 months prior to informed consent for HCC diagnosis; * Unstained slides obtained within 3 months prior to informed consent for HCC diagnosis; * Undergo biopsy to confirm GPC3-positive HCC. * Resection samples are not acceptable. * At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria. Exclusion Criteria: * Child-Pugh C. * Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception. * Patients known to be positive for Human immunodeficiency virus infection. * Active infectious diseases requiring treatment except for hepatitis B and C. * Other malignancies within the last 5 years. * History of transplantation (organ, bone marrow transplantation,peripheral blood stem cell transplantation, etc.). * Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug. * Patients with brain metastases, other central nervous system or other psychiatric disease. * Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1. * Patients who received the following treatments within 2 weeks prior to Day1: * Anticoagulant or thrombolytic agents for therapeutic purposes. * Systemic anti-viral therapy for hepatitis C/cirrhosis. * Blood transfusion * History of hypersensitivity to similar agents. * Patient is unable to comply with the requirements of the protocol and/or follow-up procedures. (Extension Phase) * Child-Pugh B or C. * Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception. * Patients known to be positive for Human immunodeficiency virus infection. * Active infectious diseases requiring treatment except for hepatitis B and C. * Other malignancies within the last 5 years. * History of transplantation (organ, bone marrow transplantation, Peripheral blood stem cell transplantation, etc.). * Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug. * Patients with brain metastases, other central nervous system or other psychiatric disease. * Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1. * Patients who received the following treatments within 2 weeks prior to Day 1: * Anticoagulations or thrombolytic agents for therapeutic purposes. * Systemic anti-viral therapy for hepatitis C/cirrhosis. * Blood transfusion * History of hypersensitivity to similar agents. * Patient is unable to comply with the requirements of the protocol and/or follow-up procedures. * IHC confirmed GPC3-negative HCC tumor tissue. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00746317

{ "NCT_ID" : "NCT05845294", "Brief_Title" : "A Study of the Effect of Short-term Structured Psychological Care in Patients", "Official_title" : "A Study of the Effect of Short-term Structured Psychological Care on the Level of Postoperative Stigma in Patients With Colorectal Cancer", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Procedure: Short-term structured psychological Care", "Procedure: Routine Care"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy. #Intervention - PROCEDURE : Routine Care - Routine care for patients undergoing colorectal cancer stoma - PROCEDURE : Short-term structured psychological Care - Short-term structured psychological care for colorectal cancer stoma patients based on conventional care

#Eligibility Criteria: Inclusion Criteria: * voluntary participation in the study and ability to cooperate with treatment and care; * patients who were to undergo enterostomy; * age >=18 years; * consciousness (being able to complete the questionnaire alone or able to answer the questions correctly); * social impact scale (SIS) score >=24. Exclusion Criteria: * Critically ill and unable to cooperate with the study; * Impaired cognitive function that affects communication; * Patients with other organic diseases in combination. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT05845294

{ "NCT_ID" : "NCT00903760", "Brief_Title" : "Decitabine and Clofarabine in Higher Risk Myelodysplastic Syndromes (MDS)", "Official_title" : "A Randomized Study of Decitabine Alternating With Clofarabine Versus Decitabine Until Failure in Patients With Higher Risk Myelodysplastic Syndromes (MDS)", "Conditions" : ["Myelodysplastic Syndrome"], "Interventions" : ["Drug: Decitabine", "Drug: Clofarabine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this clinical research study is to learn if sequential administration of decitabine and clofarabine can help to control MDS better than decitabine alone. The safety of this drug combination will also be studied. Detailed Description The Study Drugs: Decitabine is designed to damage cells' DNA (genetic material), which may cause myelodysplastic marrow cells to work more like normal marrow cells. Clofarabine is designed to interfere with the growth and development of abnormal marrow cells. Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. * If you are in Group 1, you will receive decitabine and clofarabine. * If you are in Group 2, you will receive only decitabine. Study Drug Administration: Each cycle is 4-8 weeks depending on how you tolerate the drug and how the MDS responds to it. Group 1: If you are in Group 1, you will receive the drugs in an alternating series of cycles. This means that you will receive decitabine for the first 3 cycles, then clofarabine for the next 3 cycles, and then repeat. This pattern will continue for up to 24 cycles. On Days 1-5 of Cycles 1-3, 7-9, 13-15, and 19-21, you will receive decitabine by vein over 1-2 hours. On Days 1-5 of Cycles 4-6, 10-12, 16-18, and 22-24, you will receive clofarabine by vein over 1-2 hours. Group 2: If you are in Group 2, you will receive decitabine by vein over 1-2 hours on Days 1-5 of every cycle. Study Visits: On Day 1 of every cycle, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your weight and vital signs. * Your performance status will be recorded. Once a week, blood (about 1-2 teaspoons) will be drawn for routine tests. At the end of Cycle 3, you will have a bone marrow aspirate to check the status of the disease. If the disease has not gone into remission after Cycle 3, your next bone marrow aspirate will depend on your group. If you are in Group 1, you may have another aspirate about 3 weeks after you begin Cycle 4. After that, you may have an aspirate every 2 weeks (or more often if your doctor feels it is needed) until the response (or lack thereof) is confirmed. If you are in Group 2, you may not have another bone marrow aspirate until after the end of Cycle 6. You will need to stay in Houston to receive the study drug(s). When you have study visits where you are not receiving study drug(s), these tests can be performed by your local doctor. If your MD Anderson leukemia doctor approves, your study drug can be administered outside MD Anderson by your local doctor. Length of Study: You will be on study for up to 24 cycles. You will be taken off study early if the disease gets worse or you experience any intolerable side effects. Follow-up Visits: After your last dose of study drug, you will have follow-up visits. You will only have these visits if the disease has responded to the study drug. * Once a month, blood (about 1 tablespoon) will be drawn routine tests. This can be done at home through your local cancer doctor. * Every 6 months, you will return to Houston for a physical exam and blood (about 1 tablespoon) will be drawn for routine tests. This is an investigational study. Clofarabine is FDA approved and commercially available for use in pediatric patients with a type of blood cancer (acute lymphocytic leukemia -- ALL). Its use in patients with MDS is investigational. Decitabine is FDA approved and commercially available for use in patients with MDS. Up to 80 patients will take part in this study. All will be enrolled at MD Anderson. #Intervention - DRUG : Decitabine - Decitabine 20 mg/m\^2 by vein daily over 1-2 hours for 5 days for both Group 1 and Group 2. Group 1 receives decitabine on Days 1-5 of Cycles 1-3, 7-9, 13-15, and 19-21; and Group 2 is on Days 1-5 of every cycle. - Other Names : - Dacogen® - DRUG : Clofarabine - Clofarabine 10 mg/m\^2 by vein daily over 1-2 hours for 5 days on Days 1-5 of Cycles 4-6, 10-12, 16-18, and 22-24. - Other Names : - Clolar®

#Eligibility Criteria: Inclusion Criteria: * Patients with higher risk MDS (IPSS int-2 or high, or >= 10% blasts as defined by WHO or FAB). - No prior intensive chemotherapy or high-dose cytarabine (>= 1 g/m2). - Prior biologic therapies (<= 1 cycle of prior decitabine or azacitidine), targeted therapies, or single agent chemotherapy is allowed. - Off chemotherapy for 2 weeks prior to entering this study with no toxic effects of that therapy, unless there is evidence of rapidly progressive disease. - Hydroxyurea is permitted for control of counts prior to treatment. - Hematopoietic growth factors are allowed. . * Age >= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status <= 2. * Have adequate renal function (serum creatinine <= 1.5 mg/dL) * Serum bilirubin <= 1.5 x upper limit of normal (ULN) * Aspartate transaminase (AST) or alanine transaminase (ALT) <= 2.5 x ULN * Alkaline phosphatase <= 2.5 x ULN * Provide signed written informed consent. * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. * Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment. * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Exclusion Criteria: * Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol. * Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy. * Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment. * Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) * Pregnant or lactating patients. * Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results * Any concurrent malignancy (with the exception of exclusion # 8) * Exceptions to inclusion # 7: a) Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00903760

{ "NCT_ID" : "NCT02648724", "Brief_Title" : "Sym015 (Anti-MET) in Patients With Advanced Solid Tumor Malignancies", "Official_title" : "An Open-Label, Multicenter Phase 1a/2a Trial Investigating the Safety, Tolerability and Antitumor Activity of Multiple Doses of Sym015, a Monoclonal Antibody Mixture Targeting MET, in Patients With Advanced Solid Tumor Malignancies", "Conditions" : ["Oncology", "MET Gene Amplification", "NSCLC", "MET Gene Mutation", "Non Small Cell Lung Cancer"], "Interventions" : ["Drug: Sym015"], "Location_Countries" : ["Denmark", "Korea, Republic of", "Taiwan", "Hong Kong", "United States", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This is the first study to test Sym015 in humans. The primary purpose of this study is to see if Sym015 is safe and effective for patients with advanced solid tumor malignancies without available therapeutic options. Detailed Description In the first part of the study (Part 1, dose-escalation), Sym015 was evaluated for safety and tolerability. Additionally, the recommended Phase 2 dose (RP2D) was to be determined. Sym015 was given at different dose levels on an every second week (Q2W) dosing schedule. Each patient was given one single weight based dose level. In the second part of the study (Part 2, dose-expansion), dosing was to be at the RP2D on a Q2W dosing schedule. Three cohorts were included: * Basket Cohort: Patients with KRAS wild-type (WT) advanced solid tumor malignancies with MET-amplification and without therapeutic options. Patients must have no prior therapy with MET-targeting agents, except a subset of patients having received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI). As of December 2018, accrual to this cohort was suspended. * Non-Small Cell Lung Carcinoma (NSCLC) MET-Amplified Cohort: Patients with advanced NSCLC with MET-amplification, and without available therapeutic options. Patients may have received prior therapy with MET-targeting and/or epidermal growth factor receptor (EGFR)-targeting agents. * NSCLC with MET exon 14 skipping alteration (METex14del) Cohort: Patients with advanced NSCLC METex14del, and without therapeutic options. Tumors need not be MET-amplified, and patients may have received prior therapy with MET-targeting and/or EGFR-targeting agents. #Intervention - DRUG : Sym015 - Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET. - Other Names : - Anti-MET

#Eligibility Criteria: Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Life expectancy >3 months assessed during Screening. * Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic, and that is refractory to standard therapy or for which no standard therapy is available or accessible. * If female and of childbearing potential: a negative pregnancy test. * Male or female: either not of childbearing potential or agreeing to use a medically effective method of contraception as per institutional standards during the trial and for 4 months after the last dose of trial drug. * Part 1 ONLY: Tumor documented to be KRAS WT by local assessment. * Part 2 ONLY: * Measurable disease according to RECIST v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to Cycle 1/Day 1 (C1/D1). * Basket Cohort ONLY: * Tumor documented to be KRAS WT by local assessment according to institutional standards. If KRAS WT is not previously documented and if archival tissue is not available for pretrial assessment, patient must be willing to undergo a tumor biopsy to confirm eligibility. * Confirmed MET-amplification by local assessment. * No prior therapy with MET-targeting agents (except a subset of patients having received prior therapy with a MET-targeting TKI). * Willingness to undergo a pre- and post-dosing biopsy (maximum of 2 biopsies) from primary or metastatic tumor site(s) considered safely accessible for biopsy * NSCLC MET-Amplified Cohort ONLY: * Documented NSCLC meeting disease criteria as defined per protocol. * Documented MET-amplification. * May have received prior therapy with MET-targeting and/or EGFR-targeting agents (antibodies or TKIs). * Willingness to undergo a pre-dosing biopsy (mandatory unless a recent tumor biopsy is available), and potentially a biopsy at the End of Cycle 2 (EOC2) (optional), from a primary or metastatic tumor site considered safely accessible for biopsy. * NSCLC METex14del Cohort ONLY: * Documented NSCLC meeting disease criteria as defined per protocol. * Documented METex14del (tumors need not be MET-amplified). * May have received prior therapy with MET-targeting and/or EGFR-targeting agents (antibodies or TKIs). * Willingness to undergo a pre-dosing biopsy (mandatory unless a recent tumor biopsy is available), and potentially a biopsy at the EOC2 (optional), from a primary or metastatic tumor site considered safely accessible for biopsy. Exclusion Criteria: * Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1. * Immunosuppressive or systemic hormonal therapy within 2 weeks prior to C1/D1, with exceptions. * Use of hematopoietic growth factors within 2 weeks prior to C1/D1. * Active second malignancy or history of another malignancy within the last 3 years, with exceptions. * Central nervous system (CNS) malignancy including primary malignancies of the CNS and known, untreated CNS or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required. * Inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy. * Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any prior surgical procedure. * Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to C1/D1, unless adequately treated and stable. * Active uncontrolled bleeding or a known bleeding diathesis. * Significant cardiovascular disease or condition. * Abnormal hematologic, renal or hepatic function. * Part 2 ONLY: * Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is documented progression of the lesion following the radiotherapy. * Basket Cohort ONLY: * Prior therapy with MET-inhibiting agents (exceptions will be a subset of patients that will be entered to the Basket Cohort after having received prior therapy with a MET-targeting TKI). * Prior therapy with antibody to hepatocyte growth factor (HGF). * Basket Cohort and NSCLC MET-Amplified Cohort ONLY: * Tumor status demonstrating MET-polysomy in the absence of MET-amplification, as specified per protocol. Patients in the NSCLC METex14del Cohort with polysomy are eligible. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02648724

{ "NCT_ID" : "NCT00082303", "Brief_Title" : "Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin's Lymphoma", "Official_title" : "Music Imagery for Patients in Protected Environments", "Conditions" : ["Leukemia", "Lymphoma, Non-Hodgkin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma. Detailed Description Standard treatment for acute leukemia and high-grade non-Hodgkin's lymphoma includes intensive chemotherapy that typically requires a 4-week hospital stay in protective isolation. Patients treated in isolation units may experience elevated levels of psychological distress. Both guided imagery and music therapy have been effective in improving the moods of cancer patients, but studies have not been conducted in acute leukemia and non-Hodgkin's lymphoma patients. This study will evaluate the effect of music imagery on these patients. Participants in this study will be randomly assigned to receive either standard care plus music imagery or standard care alone. Participants assigned to the standard care plus music imagery group will receive a 45-minute weekly music imagery session with a music therapist. All participants will complete questionnaires and self-reports regarding their general anxiety, affect, and fatigue. #Intervention - BEHAVIORAL : Music Imagery

#Eligibility Criteria: Inclusion Criteria: * Admitted to Indiana University Hematologic Malignancy Program for the treatment of newly diagnosed or recurrent acute leukemia or high-grade non-Hodgkin's lymphoma * Able to read and understand English Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00082303

{ "NCT_ID" : "NCT01344876", "Brief_Title" : "Phase I Study of OPB-51602 in Patients With Hematologic Malignancies", "Official_title" : "A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)", "Conditions" : ["Multiple Myeloma", "Non-Hodgkin Lymphoma", "Acute Myeloid Leukemia", "Acute Lymphoid Leukemia", "Chronic Myeloid Leukemia"], "Interventions" : ["Drug: OPB-51602"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To determine the maximum tolerated dose (MTD) of OPB-51602 #Intervention - DRUG : OPB-51602 - once daily during the treatment period

#Eligibility Criteria: Inclusion Criteria: * Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML. * Patients who are responsive or have relapsed following standard treatment * Patients capable of providing written informed consent * Japanese patients age 20 <= age <= 75 (inclusive) at time of informed consent * ECOG performance status score of 0 <= age <= 1 * Life expectancy of at least 3 months * Adequate vital organ function * Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration Exclusion Criteria: * Patients with other primary malignant tumors * Symptomatic CNS involvement * Ongoing or active infection, or complication that is not controllable by medication or other means * Complication of uncontrolled cardiac disease * Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period * Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment Sex : MALE Ages : - Minimum Age : 20 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01344876

{ "NCT_ID" : "NCT00490360", "Brief_Title" : "Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head", "Official_title" : "Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head", "Conditions" : ["Cancer of the Pancreatic Head"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Detailed Description Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed. Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30. * Trial with medicinal product #Intervention - DRUG : Gemcitabine / Cisplatin

#Eligibility Criteria: Inclusion criteria: - Age > 18 years * Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head * WHO-performance status 0 <= age <= 2 * Written informed consent * Discussion in an intrdisciplinary conference Exclusion criteria: - Insufficient renal function (calculated creatinin clearance < 60ml(min) * Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul) * Uncorrectable coagulopathy * Severe cholestasis (bilirubin >100mmol/l) * Distant metastases in liver, lungs or other organs * Peritoneal carcinomatosis * Unresectable tumor (s. 4.2.) * Contraindication for Whipple procedure * Uncontrolled infection * Neurotphil count > °2 * Estimated life experience < 6 months * HIV Infection * Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent * Female patients in child-bearing age without adequate contraception Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00490360

{ "NCT_ID" : "NCT02500004", "Brief_Title" : "Brown Adipose Tissue Activity and Energy Metabolism in Cachexia", "Official_title" : "Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease", "Conditions" : ["Cachexia", "Neoplasms", "Pulmonary Disease, Chronic Obstructive", "Pancreatic Neoplasms"], "Interventions" : ["Radiation: DXA scanning", "Other: Indirect calorimetry", "Device: Accelerometry", "Procedure: Abdominal subcutaneous adipose tissue biopsy", "Other: Double-labeled water", "Radiation: 18F-FDG PET-MRI-imaging", "Procedure: Blood sampling"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease. Detailed Description This is a prospective, cross-sectional study to determine BAT activity in cachectic patients with pancreatic or non-small cell lung cancer, and in cachectic patients with chronic obstructive pulmonary disease (COPD), and compare results with healthy individuals and non-cachectic COPD patients, matched for age and BMI. #Intervention - RADIATION : 18F-FDG PET-MRI-imaging - BAT activity: 18F-FDG PET-MRI-imaging. - RADIATION : DXA scanning - Body composition: DXA scanning, D2O and MRI. - PROCEDURE : Abdominal subcutaneous adipose tissue biopsy - Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. - PROCEDURE : Blood sampling - Systemic inflammatory profile: blood sampling. - OTHER : Indirect calorimetry - Resting metabolic rate: indirect calorimetry. - DEVICE : Accelerometry - Physical activity level: accelerometry. - OTHER : Double-labeled water - Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.

#Eligibility Criteria: Inclusion Criteria: * Pancreatic cancer patients, or NSCLC cancer patients, or COPD patients * The diagnostic criterion for cachexia is unintentional weight loss more than 5% over the past 6 months or more than 2% in individuals with a body-mass index < 20 kg/m2 and muscle wasting assessed by DXA; * Age >= 30 years; * Gender: male and female; * Caucasians. Exclusion Criteria: * Uncontrolled Diabetes Mellitus; * Patients with severe clotting disorder; * Patients with an active second malignancy; * Psychological unstable persons presumed unfit to perform the measurements, including claustrophobia; * Persons unable to lie or sit still for 1 <= age <= 2 hours; * Oxygen therapy; * Pregnant subjects;Subjects unable to undergo MRI (e.g. pacemaker; neurostimulator; implantable cardioverter-defibrillator (ICD) or leads; Foley bladder catheter; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; vascular clips; denture, which contains magnets); * Subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history; * Persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves; * The use of medication that influences the sympathetic nerve system: ß-blockers, α-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines). Sex : ALL Ages : - Minimum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT02500004

{ "NCT_ID" : "NCT01547416", "Brief_Title" : "The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function", "Official_title" : "The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function After Robot-assisted Prostatectomy", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: epidural 250mL of 0.2% ropivacaine and 2 μg/mL of fentanyl, 5 mL/hr continuous infusion and 0.5 mL bolus dose", "Drug: no epidural drug administered"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The aim of this study was to investigate whether robot assisted laparoscopic radical prostatectomy give rise to the impairment of diaphragmatic function postoperatively, and whether combined general/epidural anesthesia could provide better postoperative diaphragmatic function. Detailed Description Diaphragmatic dysfunction after abdominal surgery can result in extended hospital stay and increased medical costs, because it is related with atelectasis, lung collapse or pneumonia. The mechanism of diaphragm dysfunction is thought to be from not only direct injury to abdominal wall and viscera but inhibitory reflexes of phrenic activity. Thoracic or upper abdominal surgery is suggested as a risk factor of postoperative diaphragm dysfunction, and perioperative analgesic modality is also known to affect diaphragm movements. But there has been no trial to investigate the effect of laparoscopic pelvic surgery such as prostatectomy on diaphragm movement. Moreover, it is not clear if minimally invasive Robot-assisted laparoscopic radical prostatectomy (RALRP) has any influence on respiratory and diaphragm functions. #Intervention - DRUG : epidural 250mL of 0.2% ropivacaine and 2 μg/mL of fentanyl, 5 mL/hr continuous infusion and 0.5 mL bolus dose - Before the induction of anesthesia, epidural catheter was inserted in group GE at T8/9, T9/10, or T10/11 interspinous space with a 17-gauge Tuohy needle in lateral decubitus position and advanced 5 cm cephalad. . Epidural analgesia was maintained using the patient-controlled analgesia technique containing 250 mL of 0.2% ropivacaine and 2 μg/mL fentanyl with setting of 5 mL/hr for continuous infusion and 0.5 mL of bolus dose. Lockout time was set to 15 min. General anesthesia was induced with 2 mg/kg of propofol and 50 mg of rocuronium. After tracheal intubation, anesthesia was maintained with sevoflurane. All the patients were ventilated with controlled mode of 8 mL/kg of ideal body weight and respiratory rate was adjusted to maintain end-tidal carbon dioxide between 35-40 mmHg. - DRUG : no epidural drug administered - Patients allocated to general anesthesia group and DID NOT receive epidural anesthesia. General anesthesia was induced with 2 mg/kg of propofol and 50 mg of rocuronium. After tracheal intubation, anesthesia was maintained with sevoflurane. All the patients were ventilated with controlled mode of 8 mL/kg of ideal body weight and respiratory rate was adjusted to maintain end-tidal carbon dioxide between 35-40 mmHg.

#Eligibility Criteria: Inclusion Criteria: * Patients of > 18 years undergoing elective Robot-assisted laparoscopic radical prostatectomy Exclusion Criteria: * Patients with previous history of smoking, cardiopulmonary or neuromuscular disease or obesity (body mass index > 30 kg.m-2) Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01547416

{ "NCT_ID" : "NCT01681823", "Brief_Title" : "Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA", "Official_title" : "Phase III, Single-Center, Open Label, Trial Evaluating the Safety and Efficacy of PectaSol-C Modified Citrus Pectin on PSA Kinetics in Prostate Cancer in the Setting of Serial Increases in PSA", "Conditions" : ["Prostatic Neoplasms"], "Interventions" : ["Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)"], "Location_Countries" : ["Israel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To determine if the oral administration of PectaSol-C Modified Citrus Pectin (MCP) is effective at improving Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels. Also, documentation of any side effects or benefits within parameter of the study is included. Detailed Description This study on the effect of PectaSol-C Modified Citrus Pectin (MCP) with subjects selected on the basis of documented PC post local therapy, and biochemical relapse, with linear progression of at least 3 PSA tests in at least 3 months. After initial screening, treatment {4.8 grams (6 capsules) three times a day away from meals} will continue for 6 months provided patients are showing benefit and tolerating the therapy well. Patient tolerability of MCP will be assessed by comparing the results of monthly self-assessment diaries with baseline assessments. Prostate cancer is the most common cancer among men, except for non melanoma skin cancer. It is the second leading cause of cancer related death in men. About 33% of prostate cancer patients treated with primary therapy (surgery or radiation) will recur in the form of non metastatic biochemically relapsed prostate cancer (BRPC-M0). In these patients, PSA is rising while scans are negative for metastasis. Recent surveys demonstrated that approximately 40% of prostate cancer patients use various complementary and alternative medicine modalities as a component of therapy. Currently, there is no standard treatment for biochemical failure with proven benefits. Patients are being encouraged to enroll in clinical trials to help establish standards of care. Studies have shown that in 80% of patients with BRPC-M0, PSA will rise by at least 25% every 6 months. Native pectin is a complex carbohydrate soluble fiber. Dietary fibers, such as pectin, have been shown to have positive effects on a wide spectrum of pathological conditions. Their positive influence on human health is explained by their antioxidative, hypocholesterolemic, and anticancer effects. MCP is composed of short, slightly-branched, carbohydrate chains derived from the soluble albedo fraction of citrus fruit peels, which have been altered by decreasing the molecular weight and degree of esterification using pH, temperature, and a controlled enzymatic process. This specific modification is critical as it allows for the absorption of MCP into the circulatory system and ensures its targeted bioactivity throughout the body. MCP is relatively rich in galactose and thus antagonizes the binding protein galectin-3 which results in suppression of cancer cell aggregation, adhesion, and metastasis. MCP acts as a ligand for galectin-3, which plays a major role in tumor formation and progression. It has been shown using a combination of fluorescence microscopy, flow cytometry, and atomic force microscopy, that pectin galactan specifically binds to the recombinant form of human galectin-3. MCP showed anti-metastatic effects on cancer cells in multiple in vitro and in vivo studies. MCP inhibits carbohydrate mediated tumor growth, angiogenesis and metastasis via effects on galectin-3 function as demonstrated in an animal study on MCP's inhibition of breast and colon cancer progression. Results demonstrated a 70.2% reduction in breast tumor growth, a 66% reduction in breast angiogenesis, and 0% breast to lung metastasis compared to 100% in the control group; 0% colon to liver metastasis compared to 60% in the control group; and 25% colon to lymph metastasis compared to 100% in the control group. In an earlier study oral intake of MCP had been shown to act as a potent inhibitor of spontaneous prostate carcinoma metastasis in an animal model, demonstrating a significant 56% reduction in lung metastases. Human cancer cell lines (LNCaP androgen dependent \& PC3 androgen independent) and mouse prostate cancer cell lines (CASP2-1 androgen dependent and CASP1-1 androgen independent) treated with 1% MCP showed the following cytotoxicity due to induced apoptosis: 52.28% in LNCaP; 48.16% in PC3; 23.03% in CASP2-1; and 49.01% in CASP1-1.13 The effects of MCP on cell-cell and cell-matrix interactions mediated by carbohydrate-recognition were investigated by looking at MCP-inhibited B16-F1 melanoma cells adhesion and aggregation. MCP was shown to inhibit anchorage-independent growth of B16-F1 cells. These results indicate that carbohydrate-recognition by cell surface galectin-3 is involved in cell-extracellular matrix interaction and plays a role in anchorage-independent growth as well as the in vivo embolization of tumor cells. The modulation of the lung colonization of B16-F1 melanoma cells by MCP was first observed in 1992 when injection of MCP significantly decreased B16-F1 experimental metastasis (greater than 90%). Galectin-3 participation in the adhesion of the MDA-MB-435 cells to the endothelium was observed by the clustering of galectin-3 on endothelial cells at the sites of the contact with tumor cells, suggesting its potential functional significance for anti-adhesive therapy of cancer metastasis. The anti-metastatic effect of MCP has also been shown in reduced liver metastasis in a dose-dependent manner. The use of MCP in combination with the chemotherapy drug doxorubicin has demonstrated an increased cytotoxicity effect of inducing rapid cell death in prostate cancer cell lines DU-145 (androgen independent) through apoptosis, and in LNCaP (androgen dependant) through cell cycle arrest (G2-M arrest). These results show promise for the use of MCP with doxorubicin as an adjuvant to chemotherapy which may allow for lower dosage of the cancer drug to be used with less toxicity. A human clinical pilot trial with MCP showed an increase in prostate specific antigen doubling time, a marker of slowing the progression of prostate cancer. Clinical research on MCP also demonstrated a significant improvement in quality of life and stabilization of disease for patients with advanced solid tumors. In addition to its therapeutic roles against cancer, MCP has been shown to remove toxic metals from the body without affecting essential minerals. In a clinical study, baseline levels of heavy metals and essential minerals were established with 24-hours urine collection prior to oral administration of MCP. 24-hours urine collection was repeated on days 1 and 6. Urinary excretion of lead, mercury, cadmium, and arsenic increased significantly, essential minerals were not changed significantly and no side effects were reported. In a hospital study in China, children with lead toxicity were given MCP. Their blood serum levels went down while corresponding lead levels in their urine increased significantly, without side effects. MCP has immunostimulatory properties as demonstrated in human blood samples, including the activation of functional NK cells against K562 leukemic cells in culture: Unsaturated oligogalacturonic acids appear to be the immunostimulatory carbohydrates in MCP. Human blood samples collected from healthy volunteers were incubated with increasing concentrations of MCP and antibodies. After 24-hours, blood-antibody mix was lysed and run on a flow cytometer using a 3-color protocol and the % of activated T-cytotoxic cell subset, B-cell, and NK-cells, and % increase over untreated control calculated and a significant dose dependent activation was seen. The ability of the activated NK cells to induce leukemia cell death was analyzed by co-incubating MCP-treated lymphocytes with K562 T-cell leukemia cells and induced leukemia cell death was determined to be greater than 50%. MCP has been demonstrated to be protective in experimental nephropathy with modulation of early proliferation and later galectin-3 expression, apoptosis and fibrosis by experimentally modulating galectin-3 in folic acid (FA)-induced acute kidney injury. Mice were pre-treated with normal or 1% MCP-supplemented drinking water one week before FA injection. During the initial injury phase, all FA treated mice lost weight whilst their kidneys enlarged secondary to the renal insult; these gross changes were significantly lessened in the MCP group but this was not associated with significant changes in galectin-3 expression. At a histological level, MCP clearly reduced renal cell proliferation but did not affect apoptosis. Later, during the recovery phase at two weeks, MCP-treated mice demonstrated reduced galectin-3 in association with decreased renal fibrosis, macrophages, proinflammatory cytokine expression and apoptosis. Galectin-3 inhibition by MCP was demonstrated to block Aldosterone (Aldo) induced collagen type I synthesis. Rats were treated with Aldo-salt combined MCP for 3 weeks. Hypertensive Aldo-treated rats presented vascular hypertrophy, inflammation, fibrosis, and increased aortic Gal-3 expression. MCP treatment reversed all the above effects. MCP is affirmed as GRAS (generally regarded as safe) under the US Code of Federal Regulation 21CFR184.1588. #Intervention - DIETARY_SUPPLEMENT : PectaSol-C Modified Citrus Pectin (MCP) - Oral administration of PectaSol-C MCP (4.8 grams in six capsules three times a day away from food).

#Eligibility Criteria: Inclusion Criteria: * Documented PC post local therapy with undetectable Prostate Specific Antigen (PSA), and biochemical relapse (defined as post-surgery PSA > 0.2 ng/ml; post-radiation > nadir +2 ng/ml, the PSA nadir is the lowest PSA reading achieved after treatment), with linear progression of at least 3 PSA tests in at least 3 months before the commencement of the trial. * All patients must have negative bone scan and CT scan for the chest-abdomen-pelvis within 2 weeks prior to study initiation. Exclusion Criteria: * Psychological, familial, sociological or geographical conditions that may interfere with compliance with the study or prevent completion or compliance of protocol. * Other severe or poorly controlled medical condition(s). * Known allergies to any of the ingredients. * Hormonal therapy or other therapy for PC in the last 3 months. * Positive bone scan or CT scan of the chest-abdomen-pelvis. Sex : MALE Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01681823

{ "NCT_ID" : "NCT01195376", "Brief_Title" : "A Study of BEZ235 in Adult Japanese Patients With Advanced Solid Tumors", "Official_title" : "A Phase I Study of BEZ235, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors", "Conditions" : ["Advanced Solid Tumor"], "Interventions" : ["Drug: BEZ235"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary In this study, BEZ235 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese patients. #Intervention - DRUG : BEZ235

#Eligibility Criteria: Inclusion Criteria: * Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists. * At least one measurable lesion as defined by RECIST criteria for solid tumors. * Age >= 20 * Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of <= 2 * Life expectancy of >= 12 weeks * Patients must have the laboratory values Patients in the expansion part of this study have to meet the following criteria in addition to the criteria described above. * Availability of a representative tumor tissue specimen (either archival tumor or fresh tumor biopsy) for pre-screening. * Patients whose molecular status proved to meet the criteria (PIK3CA mutation/amplification and/or PTEN mutation and/or low/null PTEN expression) during pre-screening. Exclusion Criteria: * Patients who have brain metastases or who have signs/symptoms attributable and have not been assessed with radiologic imaging to rule out the presence of brain metastases * Patients with any peripheral neuropathy >= CTCAE grade 2 * Patients with unresolved diarrhea >= CTCAE grade 2 * Patients with a history of photosensitivity reactions to other drugs * Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least consecutive 1 years (i.e., who has had menses any time in the preceding consecutive 2 years), must have a negative serum pregnancy test <= 7 days prior to starting BEZ235. Other protocol-defined inclusion/exclusion criteria may apply Sex : ALL Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01195376

{ "NCT_ID" : "NCT01536834", "Brief_Title" : "Safety & Performance Study of Verruca Treatment Device", "Official_title" : "A Pilot Clinical Investigation in Adults to Evaluate the Safety and Performance of a Class IIa Medical Device for the Treatment of Plantar Warts (Verrucas)", "Conditions" : ["Verruca", "Plantar Wart"], "Interventions" : ["Device: Medical Device"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a non comparative pre-CE marking pilot clinical investigation is required to evaluate the safety and performance in intended use of the Verruca treatment - NPD396, Class IIa medical device for verrucas in the adult population. The treatment regime will be topical application of the Verruca treatment to the verruca, identified as the reference, once daily for 4 weeks. Patient \& investigator derived outcomes will also be collected to assess clinical performance and adverse events and adverse device effects will be reported to assess safety profile. Patient assessments will take place pre-treatment to determine patient demography, baseline clinical status, pain and verruca size prior to treatment. Compliance with treatment schedule will be collected via patient diary cards. Furthermore, patients will be assessed on day 2 after starting treatment and then again at 7, 14, 21 \& 28 days after starting treatment. Diary cards will completed through-out the investigation. #Intervention - DEVICE : Medical Device

#Eligibility Criteria: Inclusion Criteria: * Male or female patients aged >18 years * Patients with verrucas * Patients should be willing to take part, able to understand the information given to them and give written consent Exclusion Criteria: * Patient with more than two areas affected by verrucas on one foot * Patient who are actively treating or have treated their wart within the past 8 weeks * Patient suspected to be immunocompromised or are taking immunosuppressants * Patient who suffer from impaired feeling due to diabetes, peripheral vascular disease or neuropathy. * Current participation in another clinical investigation or participation within the last 30 days. * Patient with known sensitivity/allergies to the test materials or any of their ingredients. * Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the volunteer or affect the outcome of the investigation (as determined from self-reported medical history questionnaire). * Patient in a situation which in the view of the investigator could interfere with optimal participation in the investigation or constitute a special risk for these patients. * Patient who scar easily or are prone to hypertrophic or Keloid scarring. * Patient who have previously had an unfavourable reaction to any products for the feet and which involved swelling of the foot, or a requirement for painkillers or antibiotics. * Pregnant and lactating females, or those actively seeking to become pregnant in the next month Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01536834

{ "NCT_ID" : "NCT03252509", "Brief_Title" : "Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors", "Official_title" : "Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors", "Conditions" : ["Gastrostomy", "Head and Neck Neoplasms", "Malignant Neoplasm"], "Interventions" : ["Procedure: Percutaneous radiologic gastrostomy"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study intends to evaluate the security and success rate of large bore percutaneous radiologic gastrostomy in patients with head and neck tumors, as a outpatient procedure. Detailed Description Percutaneous gastrostomy is a procedure that intends to provide prolonged alimentary access to patients with normal gastrointestinal tract, which are unable to eat or are facing troubles with deglutition. Nowadays it is considered as the first line procedure to prolonged enteral access on this patients. The indications to perform a percutaneous gastrostomy in a cancer center are usually related to head and neck, central nervous system and esophagus tumors. In our institution around 80% of the percutaneous gastrostomy are performed in patients with head an neck tumors. Although percutaneous gastrostomy is considered a safe procedure, there are some complications related, specially in oncologic patients. Those complications are reported in about 40% of the cases. Percutaneous gastrostomy is usually performed as a inpatient procedure, which leads to hospitalization costs. However, some studies have shown that is safe and viable to perform percutaneous gastrostomy (both endoscopic or radiologic), as a outpatient procedure, in patients with head a neck tumors. As both techniques (endoscopic and radiologic) present similar results, patients treated in our institution that require a percutaneous gastrostomy are referred to endoscopic and interventional radiology departments. Some of these patients are selected to undergo an outpatient procedure, based on social and clinical criteria. The majority of the available data shows that both the endoscopic and the radiologic techniques present similar results in terms of security and rate of precocious and late complications, and that both are superior than the surgical technique, considering they are least invasive and related with lower rates of complication and costs. In the present, the traction (Gauderer-Ponsky) technique is the most widely used in our institution for the endoscopic procedure. In the interventional radiology department the percutaneous gastrostomy is performed using the introduction (Russel) technique, in which a guidewire is positioned after the stomach needle puncture, made under ultrasound or fluoroscopic guidance. After that, the tract is progressively dilated to allow the introduction of the gastrostomy balloon catheter, through the abdominal wall, using a peel-away sheath. This same technique can be performed for the endoscopic gastrostomy, using the same gastrostomy kit, but under endoscopic guidance. Some authors suggest that the introduction technique, although more challenging, is associated with less stoma infections, because is the only one that is not associated with oral catheterization. For the patients with head an neck tumors, there is also a reduced risk of metastases implants on the puncture site. Besides those considerations, the data available is still not consensual. #Intervention - PROCEDURE : Percutaneous radiologic gastrostomy - Percutaneous radiologic gastrostomy: Under conscious sedation and local analgesia, the ultrasound is performed to determine abdominal structures. The stomach is distended using room air through a nasogastric catheter or a 5 French (Fr) catheter. Gastropexy is performed under fluoroscopic guidance. The stomach is accessed using a 18 gauge (G) needle. Guidewire is advanced to the stomach. Progressive tract dilatations until the size of the gastrostomy tube is achieved. The catheter is advanced through the peel-away sheath. The catheter's balloon is inflated with 10ml of distilled water. Iodine contrast is injected to confirm position. After the procedure, the patient is observed for 3 hours. If there are no complications, the patient is discharged.

#Eligibility Criteria: Inclusion Criteria: * Surgical risk ASA I-III, Karnofsky Performance Status >70, acceptance and comprehension of the orientations and after-care, adequate social a familiar support, easy access to the hospital. Exclusion Criteria: * patients who live more than one hour away from the hospital, coagulopathies, refuse to join the protocol. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03252509

{ "NCT_ID" : "NCT00481884", "Brief_Title" : "Comparing RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients", "Official_title" : "Phase III Trial to Compare RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients", "Conditions" : ["Radiation Dermatitis"], "Interventions" : ["Other: RadiaPlexRx Gel", "Other: Aquaphor Gel"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "SINGLE" } }

#Study Description Brief Summary Primary Objective: To determine if RadiaPlexRx Hydrogel can reduce the development of grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation when compared to a petroleum-based gel (Aquaphor) commonly used as best supportive care. Detailed Description The Study Gels: RadiaPlexRx (requires a prescription) and Aquaphor (over-the-counter) are both gels that are designed to treat irradiated (received radiation) breast skin. These 2 gels contain different ingredients that may make one gel better than the other to treat irradiated breast skin. RadiaPlexRx contains hyaluronic acid (an ingredient found naturally in skin), aloe vera, and other ingredients that help the skin heal. Aquaphor is made of mostly petroleum that helps protect the skin. Application of Study Gels: If you decide to participate in this study, the following steps will be taken: * You will be given detailed instructions on how to apply both of the gels. You should not apply other gels or lotions on the areas of skin where you will be instructed to apply the study gels, unless you are instructed to do so by the treating doctor. * You will receive a supply of both gels (in tubes) with enough to last for the length of your treatment. You will know which gel is which, but each gel will be labeled with 'outer' or 'inner' so that you will know which gel to use on which side. You should not tell your treating doctor which side of the breast skin is being treated with which gel so that a fair comparison of the gels can be made. * You will apply 1 gel to the outer side of the irradiated breast skin and the other gel to the inner side of the irradiated breast skin. * If you experience any kind of allergic reaction (such as a rash) to the study gels, you should notify the study doctor or study staff immediately. Schedule for Study Gels: You will need to follow the schedule for applying the gels as follows: * You will need to apply both gels starting 1 day before the start of radiation treatments. * You will then need to apply both gels for 6 weeks during radiation treatment. * During the study period (1 day before the start of radiation treatment, during 6 weeks of radiation treatment), you will need to apply both gels 3 times (in the morning, afternoon, and evening just before going to sleep) each day at home. * During the days that you receive radiation treatment, you will be asked to apply the gels immediately after you receive your radiation treatment. This will count as 1 of the 3 daily gel applications. Clinic Visits: You will have the following tests done during your clinic visits: * Three (3) sets of photos of your breast skin will be taken (before radiation starts and during Weeks 3 and 6 of radiation therapy treatment). * During Weeks 1 through 6, you will go to the clinic to have your skin checked by your treating physician to learn the effects of each gel on your symptoms. . * You will need to return any empty tubes of study gel so that new tubes can be given if you will need more. Length of Study: If the treating doctor sees that the irradiated breast skin reacts poorly (does not improve or gets worse) or you experience any intolerable side effects, you will be taken off this study. Otherwise, the total time on this study is about 6 weeks. End-of-Study: -During your last week of radiation therapy treatment you will be asked to fill out a questionnaire about how you felt about each gel. This is an investigational study. RadiaPlexRx and Aquaphor are both FDA approved and commercially available. Up to 92 patients will take part in this study. All will be enrolled at M. D. Anderson. #Intervention - OTHER : RadiaPlexRx Gel - RadiaPlexRx Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply RadiaPlexRx gel topically 3 Times Daily to one half of the irradiated breast skin and the control, Aquaphor gel, to the other half of irradiated breast skin. This is determined through randomization process. - OTHER : Aquaphor Gel - Aquaphor Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply Aquaphor gel topically 3 Times Daily to one half of the irradiated breast skin and the experimental, RadiaPlexRx gel, to the other half of irradiated breast skin. This is determined through randomization process.

#Eligibility Criteria: Inclusion Criteria: * Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted) * Patient has breast conserving surgery (lumpectomy) for breast cancer with negative surgical margin * Stage Tis,0 <= age <= 3 N0 <= age <= 2 M0 * Patient will receive irradiation of whole breast. An additional field to treat the supraclavicular / axillary apex lymphatics is allowed, but a separate field to treat the internal mammary chain nodes is not allowed * The breast will receive radiation dose greater than or equal to 50 Gy, with or without a boost field to give additional dose to the tumor bed * Patient wears bras with cup size larger than A * Patient signs informed consent Exclusion Criteria: * Breast cancer treatment with mastectomy * Stage T4 breast cancer * Patient will require the use of tissue-equivalent bolus during radiation treatment or double treatment of junctions of radiation treatment fields * Patient will require treatment to the internal mammary chain lymph node bed using a separate radiation electron field * Patient is planned for partial-breast irradiation or Mammo-site treatment. * Patient has unhealed wound or rash in the radiation field * Patient has allergy to RadiaPlexRx or aloe vera * Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development * Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Herceptin® [Trastuzumab]) * Planned accelerated fractionation. * Planned radiation therapy to the bilateral breasts * Planned breast irradiation in the prone position Sex : FEMALE Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00481884

{ "NCT_ID" : "NCT02629523", "Brief_Title" : "Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA", "Official_title" : "A Phase II, Open-Label, Multicentre Study to Assess the Anti-tumour Activity of Afatinib in Patients With Activating Epidermal Growth Factor Receptor Mutation in Circulating Tumor DNA", "Conditions" : ["Lung Neoplasms", "EGFR Gene Mutation"], "Interventions" : ["Drug: Afatinib"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA. Detailed Description Obtaining Tumor tissue or cytology samples are not always available in some patients with lung cancer. Recently, studies showed that circulating tumor DNA can be used as a suitable substitute for mutation analysis. The sensitivity of EGFR mutation tests using circulating tumor DNA was reported in the range of 65.7% (10) to 75% (11), with high specificity and positive predictive value. In this trial, treatment efficacy of afatinib will be assessed in patients with NSCLC harboring EGFR mutations which were detected from circulating tumor DNA. #Intervention - DRUG : Afatinib - Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA. - Other Names : - Giotrif

#Eligibility Criteria: Inclusion Criteria: * Stage IIIB or IV lung cancer diagnosed radiologically with or without pathologic diagnosis * Age> 18 year-old * ECOG performance status 0~2. * Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from circulating DNA * Any one of the following criteria should be met * Unavailable or failed pathologic/cytologic diagnosis * Wild type or failed EGFR testing based on tumor tissue * No more tumor sample available for EGFR test * Measurable lesion by RECIST v1.1 * Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential. * Male patients should be willing to use barrier contraception. * Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses * Adequate organ function, defined as all of the following: * Absolute neutrophil count (ANC) >=1500/mm3 * Platelet count >= 75,000 /mm3 * Serum creatinine < 1.4 mg/dL * AST or ALT < three times the upper limit of normal Exclusion Criteria: * Prior exposure to EGFR-TKI. Prior chemotherapy will be permitted. * Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured. * Severe or unstable medical conditions such as history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of >= 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to randomisation. * Known pre-existing interstitial lung disease * Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption) * Active hepatitis B infection (defined as presence of HepB sAg and Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier. Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02629523

{ "NCT_ID" : "NCT03833726", "Brief_Title" : "Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment", "Official_title" : "Light Emitting Diode for the Treatment of Genitourinary Syndrome of Menopause Associated With Hormonal Therapy for Treating Breast Cancer: Randomized Controlled Clinical Trial", "Conditions" : ["Atrophy;Vaginal", "Breast Cancer"], "Interventions" : ["Procedure: Experimental: LED group", "Procedure: Sham Comparator: Control"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse. Detailed Description The Genitourinary Menopause Syndrome (MMS) affects up to 70% of in treatment breast cancer patients. Symptoms are due to a decrease in hormone levels or block to circulating hormones and induce functional changes in the vagina cutting in quality of life and impacting sexual function. This is a randomized, double blind trial in a sample of 74 individuals that will be performed at an specialized Pelvic Floor Care Center (CAAP) in Brazil. Will be included women age between 18 and 65 years, in adjuvant hormone therapy, with clinical signs and symptoms of vulvovaginal atrophy syndrome and cytologic evidence of atrophy, (pH \<5.0 and vaginal cytology with predominance of superficial cells). Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, pregnant women, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases. Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them compared with sham procedure, and both groups will perform five sessions of kinesiotherapy sessions. Maturation vaginal index will be checked before and after all treatment and self- administered questionnaires will be performed before each session with Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7), International Consultation on Incontinence Questionnaire - Short Form, (ICIQ-SF), Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B). At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction #Intervention - PROCEDURE : Experimental: LED group - 5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart. - PROCEDURE : Sham Comparator: Control - 5 Sessions of 8 minute with device off and heated gel, 7 days apart.

#Eligibility Criteria: Inclusion Criteria: * 18 <= age <= 65 anos * Pathological proven Breast Cancer diagnosis * Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for Tumor-Node-Metastasis) 8ª edition * Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and gynecological examination (of external structures, introitus, and vaginal mucosa) * Vaginal pH >5,0 Exclusion Criteria: * Hormone replacement less than 6 months * Diagnosis of vaginal infection * Difficulty in understanding the proposed instruments * Patients with chronic neurological degenerative diseases that preclude to be on position * Metastatic disease * Any vaginal photodynamic treatment less than 3 months Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03833726

{ "NCT_ID" : "NCT02490696", "Brief_Title" : "Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer", "Official_title" : "Comparative Study of the Hypoxia Measured in FAZA and F-miso TEP/CT Scan in Patients With Non-small Cell Lung Cancer at the Time of Diagnosis : Correlation With Immunohistochemistry", "Conditions" : ["Non-small Cell Lung Cancer"], "Interventions" : ["Device: FAZA PET scan", "Device: Miso PET scan"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry. Detailed Description The aim of the study is to compare the biodistribution of the two tracers specific for hypoxia in patients with non-small cell lung cancer. Two PET scans will be performed with FAZA and F-Miso tracers. The time between these twi PET scans will be 24 hours. another 24 hours after the late PET scan, the surgery will be done and a piece of tumor will be collected. Piece of tumor will be analysed by immunohistochemistry for hypoxia markers. The results of immunohistochemistry will be correlated with the biodistribution of the two tracers. #Intervention - DEVICE : Miso PET scan - 2 PET scans will be performed before surgery : the first one with F-Miso tracer and the second, 24 hours later, with FAZA tracer - DEVICE : FAZA PET scan - 2 PET scans will be performed before surgery : the first one with FAZA tracer and the second, 24 hours later, with F-Miso tracer

#Eligibility Criteria: Inclusion Criteria: * Male or female * More than 18 years * Patient with non-small cell lung cancer (histologically proved) * PS inferior or equal to 1 (good general state) * Patient must have surgery for their non-small cell lung cancer * Stage of tumor Superior or equal to 2a without metastasis * Tumoral fixation with 18-FDG-PET superior to mediastinal background noise * Written inform consent Exclusion Criteria: * Histology other than primitive non-small cell lung cancer * In situ form at the histological study * Patient without evaluable target * No fixation on the pretherapeutic FDG-PET scan * PS Superior or equal to 2 * neoplastic disease (less than 2 years or progressive) * Pregnant woman or child-bearing * Patient Under guardianship or curators Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02490696

{ "NCT_ID" : "NCT03274011", "Brief_Title" : "Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma", "Official_title" : "Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma: A Phase II, Prospective, Single-arm, Multicenter Trial", "Conditions" : ["Esophageal Neoplasms"], "Interventions" : ["Drug: Apatinib"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary There is no standard treatment strategy for recurrent or metastatic esophageal squamous cell carcinoma patients now, especially after the second-line treatment. Most of the patients have the bad ECOG (Eastern Cooperative Oncology Group) score and prognosis. Chemotherapy, radiotherapy, surgery are usually unacceptable for them. Previous data showed that apatinib treatment significantly improved OS(overall survival) and PFS(progression-free survival) with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. The study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial. #Intervention - DRUG : Apatinib - Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular en-dothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. Previous data showed that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Our study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.

#Eligibility Criteria: Inclusion Criteria: * Patient age: >=18 years * An ECOG score of 0 <= age <= 2 * Pathologically diagnosed with Esophageal Squamous Cell Carcinoma. * At least second-line treatment failure regimens without targeted therapy. * Measurable lesion. * An expected survival of >= 3 months. * Major organ function had to meet the following criteria: 1)For regular test results: HB(hemoglobin) >= 90g / L (14 days without blood transfusion); ANC(absolute neutrophil count) >= 1.5 × 109 / L; PLT(platelet) >= 80 × 109 / L 2)Biochemical tests results: Bilirubin <1.5 times the upper limit of normal (ULN) ALT(Alanine aminotransferase) and AST<=2.5 × ULN; liver metastases, if any, the ALT and AST<=5 × ULN; Endogenous creatinine clearance>=50ml/min (Cockcroft-Gault formula) 8. Informing consent. Exclusion Criteria: * Previously or presently suffering from other malignancies, except for the cured and stable carcinoma; * Pregnant or lactating women; * Participation in clinical trials with other drugs in the preceding four weeks. * Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction). * Serious bleeding events within 4weeks (>=3 degree)-CTCAE(Common Terminology Criteria for Adverse Events) 4.0 * Central nervous system metastasis or a history of central nervous system metastasis. * Hypertension and antihypertensive drug treatment that does not normalize blood pressures (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg); With unstable angina pectoris; Arrhythmia; Coronary heart disease greater than Class II; Angina pectoris diagnosed with 3 months or myocardial infarction event occurs within 6 months before recruiting. * With the open wounds or fractura. * A history of organ transplant. * Coagulation dysfunction (PT(prothrombin time)>16 s, APTT(activated partial thromboplastin time)>43 s, TT(thrombin time)>21 s, Fbg(Fibrinogen)<2g/L), a tendency to bleed or receiving thrombolytic or anticoagulant therapy. * A history of abuse of psychotropic drugs or mental disorders. * Central nervous system disorders. * A history of immunodeficiency. * Arterial/venous thrombosis events within 12 months before recruiting. * Use of CFDA(China Food and Drug Administration) approved anti-gastric modern traditional Chinese medicine preparations and immunomodulatory agents. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03274011

{ "NCT_ID" : "NCT02034955", "Brief_Title" : "Prostatectomy Adaptive Radiation Therapy (ART)", "Official_title" : "A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Radiation: Post-operative Adaptive Radiation Therapy"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients. #Intervention - RADIATION : Post-operative Adaptive Radiation Therapy - Other Names : - All Patients enrolled in this study will have additional scans (Cone-Beam CT,MRI) daily during their treatment. This extra imaging will help us see any, changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.

#Eligibility Criteria: Inclusion Criteria: * Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND * Clinical stage pT3, pT4, or pT2 with positive margin OR * Any p-Stage with a persistently elevated post-operative PSA > 0.05 ng/ml OR * A delayed rise in PSA post-operatively Exclusion Criteria: * Inflammatory bowel disease or other contraindications to radiotherapy * Prior pelvic radiotherapy * Previous cytotoxic chemotherapy * Radiological or pathologic evidence of nodal metastases. * Planned radiotherapy to pelvic lymph nodes * Evidence of systemic metastases on imaging. * Prosthetic hip replacement * No signed informed consent Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02034955

{ "NCT_ID" : "NCT03421912", "Brief_Title" : "Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)", "Official_title" : "Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers", "Conditions" : ["Head and Neck Squamous Cell Carcinoma", "Colorectal Cancer", "Non Small Cell Lung Cancer", "Epidermal Growth Factor Receptor Inhibitor"], "Interventions" : ["Other: Cicaplast Balm B5", "Other: Dexeryl"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary Detailed Description The arrival of new therapeutic strategies such as targeted therapies has led to real progress in the treatment of cancers. Tyrosine kinase inhibitors and antibodies to epidermal growth factor receptors (EGFR), or iEGFR, target one of the major pathways of tumor cell proliferation. These treatments have demonstrated their interest in the treatment of certain advanced solid malignant tumors (head and neck cancer, colorectal cancer, bronchial cancer). Although having a much better tolerance profile than the 'classical' cytotoxic treatments used in the same indications, these treatments, however, have frequent cutaneous toxicities that are inconvenient for patients. According to the molecules, they can affect 80 to 90% of patients treated from the first weeks of treatment and to different degrees. They appear as well in the skin (acneiform rash, erythema, desquamation, xerosis, pruritus) as skin appendages (paronychia, alopecia). The consequences of these adverse effects are significant, which may be at the origin of a decrease in dose or even of a stop of anti-tumoral treatment inducing a reduction of the expected clinical benefit. In addition, they represent for the patient a real source of inconvenience and pain, which can impact the quality of life (choice of dress, feeling of shame because of the appearance of the skin ...) and impact the adherence to iEGFR treatment. Management includes first and foremost preventive measures: the use of moisturizing topicals and dermatological soap-free surgras is recommended as soon as iEGFR treatment is initiated, and preventive systemic treatment with cyclins (doxycycline 100 mg daily) is proposed for at least 6 weeks and then reevaluated for skin toxicity. In case of appearance of skin toxicities, it is initially prescribed in common practice a topical such as Dexeryl (used in many hospitals as standard) or Cicaplast Balm B5 La Roche Posay (used in current practice at Léon Bérard Center). In a second step, topical corticosteroids are prescribed, depending on the grade of toxicity. There is, however, no validated argument in the literature to guide the choice of clinicians to use either of these topics. Cicaplast balm B5 (antibacterial, repairing damaged skin, moisturizing and relieving feelings of discomfort) would limit the aggravation of skin toxicities and therefore the use of pharmacological measures, including topical corticosteroids class 3 or 4 may long term, weaken the skin barrier even more. This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary #Intervention - OTHER : Cicaplast Balm B5 - The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers - OTHER : Dexeryl - The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years. * Patient with recurrent and / or metastatic head and neck squamous cell carcinoma OR metastatic colorectal cancer with non-mutated RAS gene (wild-type) OR non-small cell lung cancer (NSCLC) with EGFR activating mutations. * Treated for the first time by an iEGFR having received a marketing authorization. * Having signed a consent to participate in the study. * Affiliated to a health insurance plan (or beneficiary of such a plan). Exclusion Criteria: * Concomitant radiotherapy. * Unresolved skin toxicity from previous treatment, whatever it may be. * Concomitant use of other topical treatments. * Known hypersensitivity to at least one of the components of the topicals used. * Pregnant or lactating women. * Participation in another clinical trial (even if supportive care) Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03421912

{ "NCT_ID" : "NCT01544478", "Brief_Title" : "V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)", "Official_title" : "A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women", "Conditions" : ["Cervical Cancer", "Cervical Intraepithelial Neoplasia", "Adenocarcinoma in Situ"], "Interventions" : ["Biological: V501"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women. #Intervention - BIOLOGICAL : V501 - HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6 - Other Names : - Gardasil™

#Eligibility Criteria: Inclusion Criteria: * Healthy Japanese females * Not pregnant at Screening and agree to use effective contraception through Month 7 of the study * Lifetime history of 0 to 4 male or female sexual partners * No oral temperature >=37.5 centigrade within 24 hours prior to injection Exclusion Criteria: * Received a marketed HPV vaccine * Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN * Known history of positive test for HPV * Known history of genital warts * Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study * History of splenectomy, known immune disorders, or receiving immunosuppressives * Immunocompromised or diagnosed as having human immunodeficiency virus (HIV) Sex : FEMALE Ages : - Minimum Age : 16 Years - Maximum Age : 26 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT01544478

{ "NCT_ID" : "NCT03631407", "Brief_Title" : "Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046)", "Official_title" : "A Phase 2 Trial to Evaluate the Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC)", "Conditions" : ["Colorectal Neoplasms"], "Interventions" : ["Drug: Vicriviroc", "Biological: Pembrolizumab"], "Location_Countries" : ["Canada", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This trial will evaluate the safety and efficacy of vicriviroc (MK-7690) at 2 dose levels in combination with pembrolizumab (MK-3475) in participants with advanced/metastatic microsatellite stable (MSS) colorectal cancer (CRC). #Intervention - DRUG : Vicriviroc - Vicriviroc tablets administered orally, QD at dose level 1 or 2. - Other Names : - MK-7690 - BIOLOGICAL : Pembrolizumab - Pembrolizumab administered by IV infusion at 200 mg every 3 weeks (Q3W), given on cycle day 1. - Other Names : - KEYTRUDA®, MK-3475

#Eligibility Criteria: Inclusion Criteria: * Have a histologically proven locally advanced unresectable or metastatic CRC. * Have locally confirmed MSS CRC. * Have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan, and have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit. * Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. * Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study intervention. * Male participants must agree to use contraception and refrain from donating sperm for at least 120 days after the last dose of study intervention. * Female participants must be not pregnant and not breastfeeding. Further, a female participant must either not be a woman of childbearing potential (WOCBP) or, if a WOCBP, agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention. * Have adequate organ function. Exclusion Criteria: * Have a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. * Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Have severe hypersensitivity reaction to treatment with any monoclonal antibody or components of the study interventions. * Have an active autoimmune disease requiring systemic treatment in the past 2 years, except vitiligo or resolved childhood asthma/atopy. * Have a history of vasculitis. * Have an active infection requiring systemic therapy. * Have symptomatic ascites or pleural effusion. * Have interstitial lung disease requiring oral or IV glucocorticoids. * Have a history of pneumonitis (noninfectious) that required steroids, or has current pneumonitis. * Have a known history of human immunodeficiency virus (HIV) infection. * Have a known history of hepatitis B or known active hepatitis C virus infection. * Have a known history of active tuberculosis (TB; Bacillus tuberculosis). * Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, make administration of the study interventions hazardous, or make it difficult to monitor adverse events. * Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with study requirements. * Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention. * Are a WOCBP who has a positive urine pregnancy test within 72 hours before randomization or treatment allocation. * Have undergone major surgery and have not recovered adequately from any toxicity and/or complications from the intervention before starting study intervention. * Have a seizure disorder requiring ongoing antiseizure therapy or with any condition that, in the judgment of the investigator, is likely to increase the risk of seizure (e.g., CNS malignancy or toxoplasmosis). * Have known gastrointestinal (GI) disease such as esophageal, gastric, or duodenal ulceration or inflammatory bowel disease, or history of GI surgery. * Are using any drug (therapeutic or recreational), or withdrawal thereof, that poses an increased risk of convulsions. * Have had an allogeneic tissue/solid organ transplant. * Have received prior therapy with vicriviroc or other CCR5 antagonist (e.g., maraviroc) or have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent. * Have been treated with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137). * Have received prior systemic anticancer therapy, including investigational agents, or has used an investigational device within 28 days before the first dose of study intervention. * Have received prior radiotherapy (not to target lesions) within 2 weeks of start of study intervention. * Are expected to require any other form of antineoplastic therapy while on study. * Have a diagnosis of immunodeficiency, is receiving chronic systemic steroid therapy in excess of replacement doses (prednisone <=10 mg/day is acceptable), or is taking any other form of immunosuppressive medication within 7 days before the first dose of the study intervention. * Have received a live-virus vaccine within 30 days before the first dose of the study intervention. * Are currently participating in or have participated in a study of an investigational agent, or have used an investigational device within 28 days before the first dose of study intervention. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03631407

{ "NCT_ID" : "NCT03531320", "Brief_Title" : "Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase", "Official_title" : "Open-Label, Multicenter Study of D07001-Softgel Capsules (Oral Gemcitabine Hydrochloride) in Subjects With Unresectable, Metastatic or Locally Advanced Gastrointestinal (GI) Cancer in Dose-Escalation Phase and in Subjects With Advanced Biliary Tract Cancer (BTC) Following Primary Chemotherapy or Combined Chemoradiotherapy (CCRT) in Dose-Expansion Phase", "Conditions" : ["Gastrointestinal Cancer", "Biliary Tract Cancer"], "Interventions" : ["Drug: D07001-softgel capsules"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal (GI) cancer. Part 2: Dose-Expansion Phase (Phase 2) The primary objective is to assess the safety and tolerability of D07001 softgel in patients who have achieved stable disease or better following first line chemotherapy or combined chemoradiotherapy (CCRT) for unresectable metastatic or locally advanced biliary tract cancer (BTC) Detailed Description This open label, multicenter study will be conducted in 2 parts: a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). In both Part 1 and Part 2, eligible patients will be assigned to receive oral D07001-softgel on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle (9 doses per cycle). Part 1: Dose Escalation Phase (Phase 1b) Part 1 of the study will follow a 3+3 dose escalation scheme at predefined dose levels. There will be sequential cohorts of 3 to 6 patients each with increasing doses of 40 mg, 60 mg, 80 mg, 120 mg, and 160 mg per cohort. There will be no intra patient dose escalation. Cycle 1 (21 days) is defined as the dose limiting toxicity (DLT) assessment period. Part 2: Dose Expansion Phase (Phase 2) In Part 2 of the study, eligible patients will be randomized in a 1:1 ratio to receive D07001-softgel in an open label manner at 1 of the 2 dose levels selected for expansion. Twenty (20) patients will be enrolled to each dose expansion cohort. Patients will be treated until withdrawal from treatment due to disease progression according to RECIST v1.1, withdrawn consent, or when another treatment discontinuation criterion is met. Patients who are discontinued from study drug for reasons other than disease progression or toxicity in the first 2 cycles of Part 2 will be replaced. #Intervention - DRUG : D07001-softgel capsules - Active Ingredient:Gemcitabine hydrochloride

#Eligibility Criteria: Inclusion Criteria: * Provision of a signed and dated written Informed Consent Form (ICF) prior to any study specific procedures * Male or female patients aged >= 18 years at screening (aged >= 20 years in Taiwan) * Histopathological or cytologic diagnosis of unresectable, metastatic or locally advanced GI cancer (Part 1) or unresectable metastatic or locally advanced BTC (cholangiocarcinoma or gallbladder cancer; Part 2) * Part 1 only: Refractory to or have relapsed from all standard therapies of advanced GI malignancy * Part 2 only: 1. Achieved stable disease or better, based on the Investigator's assessment, in response to first line systemic therapy or CCRT, with continued stable disease or better based on imaging studies obtained as part of screening 2. Completed first line systemic therapy (with 2 <= age <= 8 cycles of chemotherapy with a gemcitabine based regimen) or CCRT, based on the local standard of care and preferences in the participating countries Note: No more than 30% of patients enrolled in Part 2 will have received CCRT * No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment * Part 2 only: Patient has not received intervening systemic therapy since first line treatment * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 <= age <= 2 in Part 1 and 0 <= age <= 1 in Part 2 * Life expectancy is >12 weeks * Adequate bone marrow function, demonstrated by: 1. Absolute neutrophil count (ANC) >=1,500 cell/mm3 2. Platelet count >=100,000 cells/mm3 3. Hemoglobin >=9 g/dL * Adequate liver function, demonstrated by: 1. Aspartate transaminase (AST) and alanine transaminase (ALT) <=2.5 x upper limit of normal (ULN), or <=5.0 x ULN in the case of liver metastases 2. Total bilirubin <=1.5 x ULN 3. Albumin >=3.0 g/dL 4. International normalized ratio (INR) <1.5 * Adequate renal function, demonstrated by: 1. Serum creatinine <=1.5 x ULN 2. Creatinine clearance >= 60 mL/min calculated by Cockcroft-Gault formula or directly measured with 24 hr urine collection * If a woman of childbearing potential, the patient has a negative serum pregnancy test at screening and is not breastfeeding * If a woman of childbearing potential, patient must use a medically acceptable form of contraception as 2 barrier methods (e.g., combination of condom, diaphragm, or intrauterine device), hormonal contraception (estrogen or progesterone agents) or 1 barrier method in combination with spermicide. Birth control is required 1 month prior to screening, for the duration of their study participation, and for 1 month after the end of the study; female partners of male patients must adhere to the same birth control methods. * Patient is willing to comply with protocol-required visit schedule and visit requirements Exclusion Criteria: * Part 2 only: More than one prior chemotherapy regimen for unresectable metastatic or locally advanced BTC Note: prior radiation (with or without radiosensitizing doses of chemotherapy) or fluoropyrimidine chemotherapy are allowed as postsurgical adjuvant therapy. * Part 2 only: Received any systemic therapy (chemotherapy, biologics, immunotherapy, or investigational agents) for metastatic disease other than gemcitabine based chemotherapy or CCRT for locally advanced BTC * Diagnosis of active malignancy (other than GI cancer [Part 1] or BTC [Part 2]) within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent * Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or hemolytic uremic syndrome (HUS) or hypersensitivity, allergic reaction, or intolerance * Any GI disorder which would significantly impede absorption of an oral agent * Known brain or leptomeningeal metastases * Surgery or radiation therapy within the past 28 days * Part 2 only: Evidence of disease progression, based on the Investigator's assessment, on the screening computed tomography (CT) scan or magnetic resonance imaging (MRI) scan * Any active disease or condition that would not permit compliance with the protocol * Residual toxicity from prior chemotherapy or CCRT that is Grade >=2 (residual Grade 2 neuropathy and alopecia are permitted) * Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association [NYHA] Grade 2 or greater), or uncontrolled serious cardiac arrhythmia * Patient has a history of drug or alcohol abuse within last year * Patient has documented cerebrovascular disease * Patient has a seizure disorder not controlled on medication (based on decision of Investigator) * Patient received an investigational agent within 28 days of enrollment * Patients with uncontrolled active viral, bacterial, or systemic fungal infection * Patient has known human immunodeficiency virus (HIV) infection * Patient has hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in medical history. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement between the Investigator and the Clinical Research Organization (CRO) Medical Monitor * Patient has received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks prior to screening * Patient has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in, and compliance with, a clinical trial Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03531320

{ "NCT_ID" : "NCT03412357", "Brief_Title" : "MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma.", "Official_title" : "MesoTRAP: A Pilot Clinical Trial and Feasibility Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma Designed to Address Recruitment and Randomisation Uncertainties and Sample Size Requirements for a Phase III Trial.", "Conditions" : ["Malignant Pleural Mesothelioma", "Trapped Lung"], "Interventions" : ["Procedure: indwelling pleural catheter", "Procedure: pleurectomy/decortication"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Malignant pleural mesothelioma is a cancer, caused by asbestos, which currently affects 2500 people in the UK each year. The main symptom is breathlessness caused by fluid building up in the space between the lung and the chest wall (pleural effusion). Treatment involves draining the fluid to allow the lung to re-expand (pleurodesis). However, sometimes tumour growth over the surface of the lung can prevent it from re-expanding. This 'trapped' lung results in fluid re-accumulation and repeated drainage which can lead to discomfort and multiple hospital visits. One approach to dealing with 'trapped' lung in mesothelioma is to insert a thin tube (Indwelling Pleural Catheter - IPC) into the space around the lung. The tube can stay in place for a long time allowing patients to drain off fluid at home. Another approach is a keyhole surgical operation (video-assisted thoracoscopic partial pleurectomy/decortication - VAT-PD) to remove as much tumour as possible from the lining of the lung to allow it to re-expand. While both approaches are currently offered in clinical practice, it is not known which of the two is most effective at relieving breathlessness. The only way to find out is to conduct a research trial comparing the two. The Investigators plan to do this, but first of all need to carry out a small pilot study to collect information necessary to help plan the full study. Detailed Description This is a multi-centre, open-label, randomised controlled pilot clinical trial and feasibility study comparing video-assisted thoracoscopic partial pleurectomy/decortication (VAT-PD) with indwelling pleural catheter (IPC) in patients with trapped lung (TL) and pleural effusion due to malignant pleural mesothelioma (MPM), aimed at addressing recruitment and randomisation uncertainties as well as sample size requirements for a full phase III study. 38 patients will be randomised and allocated in a 1:1 ratio to either VAT-PD or IPC. The study will be undertaken at mesothelioma surgical centres with expertise in either IPC, VAT-PD or both procedures, together with their linked non-surgical referral hospitals (hub and spoke). Patients meeting all eligibility criteria will be informed about the study, provided with a patient information sheet and given at least 24 hours to consider participation. Following consent, patients will be randomised, baseline measurements will be taken and a procedure date will be arranged. Following the procedure follow-up visits at 6 weeks, 3, 6 and 12 months post-randomisation are planned to coincide with clinical care visits. In parallel with the main study an observational sub-study will collect observational data on a cohort of patients who have Malignant Pleural Mesothelioma and trapped lung, but who are either not eligible to participate, or who decline to participate in the main study. Patients in the Observational Sub-study will receive the same baseline and follow-up visits as those in the main study, but will receive standard clinical care. #Intervention - PROCEDURE : pleurectomy/decortication - VAT-PD is a type of 'keyhole surgery' performed under general anaesthesia using a telescope and instruments put inside the chest. Through small incisions, or keyholes made between the ribs, the thoracic surgeon removes the hard rind of the tumour over the surface of the lung, thereby allowing the 'trapped' lung to fully expand again. Simultaneous removal of mesothelioma from the outer pleural membrane allows pleurodesis to occur. - Other Names : - video-assisted thoracoscopic partial pleurectomy/decortication, VAT-PD - PROCEDURE : indwelling pleural catheter - A soft silicone catheter (IPC) with a one-way valve at the end is inserted a few centimetres under the skin under local anaesthesia. The inside end of the catheter is inserted into the pleural space and the outside end is connected to a vacuum drainage bottle. The IPC permits regular fluid drainage. - Other Names : - IPC

#Eligibility Criteria: Inclusion Criteria: * Pathologically confirmed MPM * Trapped lung, defined as a 'clinically significant trapped lung requiring intervention in the opinion of the clinical team' * Pleural effusion present (following re-accumulation) * Considered by the clinical team to be suitable and fit enough to undergo VAT-PD * Community services or patient/carer able to drain IPC at least twice weekly * Considered by the clinical team to be equally suitable for treatment with VAT-PD or IPC, and therefore eligible for treatment allocation by randomisation. * Patient willing to receive either VAT-PD or IPC and attend the respective designated centre for their treatment * Expected survival of at least 4 months, as assessed by managing clinician * Age >= 18 years * Able to provide informed consent Exclusion Criteria: * Lung re-expands fully following pleural fluid drainage i.e. no entrapment * Evidence of active pleural infection * Current participation in an RCT or CTIMP * Females: pregnant or lactating Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03412357

{ "NCT_ID" : "NCT04039672", "Brief_Title" : "Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAFi/MEKi in BRAF Mutated Melanoma", "Official_title" : "Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAF Inhibitors/MEK Inhibitors (BRAFi/MEKi) in BRAF Mutated Melanoma", "Conditions" : ["Melanoma"], "Interventions" : ["Procedure: Skin biopsy"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an interventional mono-centric study in patients with BRAF mutated metastatic melanoma treated with BRAF/MEK inhibitors. The aim of the study is to test the grafting of patient tumoral cells in avian embryo and develop a predictive in vivo model for patient treatment response. #Intervention - PROCEDURE : Skin biopsy - 5mm skin metastasis or primary melanoma biopsy

#Eligibility Criteria: Inclusion Criteria: * Patients aged >= 18 years * Signed written informed consent * Patient with BRAF V600 mutated metastatic or unresectable melanoma histologically confirmed * BRAFi/MEKi treatment indication * Patient with skin tumor (excluded face and skinfold) available for biopsy * Measurable disease as defined by RECIST v1.1 criteria * Patient affiliated to or a beneficiary of a social security category Exclusion Criteria: * Ocular melanoma * Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study * Pregnant or nursing (lactating) women * Patients protected by law Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04039672

{ "NCT_ID" : "NCT01385059", "Brief_Title" : "Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer", "Official_title" : "A Randomized, Phase II Study Assessing Axitinib as Pre-Surgical Therapy in Patients With High Risk Prostate Cancer", "Conditions" : ["Stage III Prostate Cancer", "Stage IV Prostate Cancer"], "Interventions" : ["Drug: axitinib", "Other: enzyme-linked immunosorbent assay", "Procedure: therapeutic conventional surgery", "Other: laboratory biomarker analysis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This randomized phase II trial studies how well axitinib works in treating patients with high-risk prostate cancer before undergoing surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib before surgery may make the tumor smaller and reduce the amount of normal cells that have to be removed Detailed Description PRIMARY OBJECTIVES: I. To determine if axitinib modulates pre-metastatic niche density in patients with high-risk prostate cancer. SECONDARY OBJECTIVES: I. To determine if pre-metastatic niche density in regional lymph nodes (LNs) is associated with progression-free survival (PFS). II. To determine if therapy with axitinib prolongs time to biochemical recurrence. III. To determine if phosphorylated form of signal transducer and activator of transcription (pSTAT)3 in tumor tissue is associated with biochemical recurrence. IV. To determine if myeloid derived suppressor cell (MDSC) recruitment in tumor tissue is associated with biochemical recurrence. V. To determine if lysyl oxidase (LOX) expression in tumor tissue is associated with biochemical recurrence. VI. To evaluate time to metastatic recurrence. VII. To determine the rate of erectile dysfunction and urinary incontinence (grade \>= 3 for both) in the setting of preoperative axitinib therapy. VIII. To evaluate changes in blood-based biomarkers (pSTAT3 and selected angiogenic factors) from baseline to the time of prostatectomy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-28. Patients then undergo prostatectomy and pelvic lymph node dissection. Treatment continues in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo prostatectomy and pelvic lymph node dissection at 5-6 weeks after biopsy confirmation of prostate cancer. After completion of study treatment, patients are followed up periodically. #Intervention - DRUG : axitinib - Given PO - Other Names : - AG-013736 - PROCEDURE : therapeutic conventional surgery - Undergo prostatectomy and pelvic lymph node dissection - OTHER : enzyme-linked immunosorbent assay - Correlative studies - Other Names : - ELISA - OTHER : laboratory biomarker analysis - Correlative studies

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed diagnosis of prostate cancer * High-risk prostate cancer as defined by 1 of the 3 following criteria: * Baseline prostate specific antigen (PSA) > 20 * Clinical stage >= T3a and * Gleason score 8 <= age <= 9 * Subjects must be appropriate candidates for prostatectomy and pelvic lymph node dissection, as deemed by multidisciplinary tumor team; subjects must provide informed consent to these procedures prior to initiating study treatment * Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol * Absolute neutrophil count (ANC) >= 1500 cells/mm^3 * Platelets >= 100,000 cells/mm^3 * Hemoglobin >= 9.0 g/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN) * Total bilirubin =< 1.5 X ULN * Serum creatinine =< 1.5 X ULN or calculated creatinine clearance >= 60 mL/min * Urinary protein < 2+ by urine analysis (UA); if UA is >= 2+ for protein then a 24-hour urine collection can be done and the patient may enter only if urinary protein is < 2 g per 24 hours * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of >= 12 weeks * No prior systemic therapy for prostate cancer * No evidence of preexisting uncontrolled hypertension as documented by 2 consecutive blood pressure readings taken within 1 hour; the baseline systolic blood pressure readings must be =< 140 mm mercury (Hg), and the baseline diastolic blood pressure readings must be =< 90 mm Hg; patients whose hypertension is controlled by antihypertensive therapies are eligible * Within 2 weeks of consent (and prior to initiating systemic therapy with axitinib if randomized to that arm), patients should visit with a radiation oncologist to discuss the option of radiation therapy (potentially with concomitant androgen deprivation therapy) for high-risk disease; if the patient has met with a radiation oncologist within 3 months of study enrollment to discuss the possibility of radiation therapy for localized prostate cancer, then this will suffice; patients do not have the right to refuse consultation; if this is the case, it must be documented by the treating physician in the medical record * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Exclusion Criteria: * Prior systemic therapy for prostate cancer (including by not limited to endocrine therapy; i.e., LHRH analogues, antiandrogens, etc.) * Evidence of metastatic disease * Prior radiation therapy for prostate cancer * Known history of allergic reactions to axitinib or other VEGF-TKIs * Presence of serious or uncontrollable infection * Major surgery <4 weeks of starting the study treatment * Gastrointestinal abnormalities including: * Inability to take oral medication * Requirement for intravenous alimentation * Prior surgical procedures affecting absorption including total gastric resection * Treatment for active peptic ulcer disease in the past 6 months * Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy * Malabsorption syndromes * Current use or anticipated need for treatment with drugs that are known potent cytochrome P450 3A4 (CYP3A4) inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine) * Current use or anticipated need for treatment with drugs that are known CYP3A4 or cytochrome P450 1A2 (CYP1A2) inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort) * Requirement of anticoagulant therapy with oral vitamin K antagonists; therapeutic use of low molecular weight heparin is allowed * Active seizure disorder * A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment * Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness * History of a malignancy (other than prostate cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years * Dementia or significant altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol * Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01385059

{ "NCT_ID" : "NCT04239560", "Brief_Title" : "Preventive Effect of Boron-based Gel on Radiation Dermatitis", "Official_title" : "Preventive Effect of Boron-based Gel on Radiation Dermatitis in Patients With Breast Cancer: Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial", "Conditions" : ["Radiodermatitis"], "Interventions" : ["Drug: Boron-based Gel (Fibore)", "Drug: Placebos"], "Location_Countries" : ["Iran, Islamic Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Preventive Effect of Boron-based Gel on Radiation Dermatitis Detailed Description * Study aim: Radiation dermatitis (RD) is observed in more than 90% of breast cancer patients who receive the radiation therapy (RT). In spite of the high number of studies in this area, there is limited high-quality and comparative research that presents definitive findings suggesting the effectiveness of any single intervention for RD prevention. So, the current phase III clinical trial study was conducted to measure the preventive effects of the aforementioned boron-based gel on different outcomes. * Design: The parallel design, randomized, double blinded and placebo controlled phase III clinical trial was conducted. One-hundred-eighty-one and seventy-six patients aged 18-75 years were assigned to intervention and placebo groups respectively. Patients in intervention and placebo groups received daily a gel containing 3% sodium pentaborate pentahydrate and gel free of any chemical treatment respectively 15 minutes before the RT session. Dermatitis, erythema, dry desquamation, moist desquamation and necrosis were compared between two groups in terms of percent and number needed to treat. * Settings and conduct: The female breast cancer patients who admitted to the Shahid Madani Hospital were initially assessed during 2018-2019 and those aged 18-75 years old with no previous history of radiotherapy were invited to the study. Pregnant women, patients with unknown dermatitis and those without any willing to participate in this study were excluded. As there was no similar study to compare our outcome studied, we included 30 patients in the pilot study. Afterwards, the sample size of 16 were calculated for each group based on the erythema to ensure the power of 0.8 and type I error of 0.05. However, we increased the sample size of the study to 181 and 76 subjects in intervention and placebo groups respectively to meet the sample size guidelines for Food and Drug Administration Phase III Clinical Trial Studies, address at least 20% attrition rate during the study, and to enhance the randomization efficiency in balancing the patterns of confounding variables between intervention and placebo groups. As there was no usual treatment for the radiation dermatitis in breast cancer patients, increasing the sample size was not ethically questionable. * Participants/Inclusion and exclusion criteria: Inclusion: Patients who are admitted to the study are enrolled in the study and have head and neck cancer in the breast, and are between the ages of 18 and 75 years old and have not received radiotherapy before. Exclusion: Pregnant women, patients with unknown dermatitis and those without any willing to participate in this study were excluded. * Intervention groups: The aim of the study was fully described to the eligible subjects and informed consent was gathered. Afterwards, the patients were assigned into the intervention and placebo groups. In the intervention and placebo groups, subjects received daily a gel containing 3% sodium pentaborate pentahydrate and gel free of any chemical treatment respectively 15 minutes before the radiotherapy session. As the gels were used on the target areas of the patients by the researchers, there was no compliance problem in this study. Afterwards, the study's outcomes were examined at 25th day of treatment for the patients in two groups. * Main outcome variables: Dermatitis and its grades including erythema, dry desquamation, moist desquamation and necrosis were considered as main outcomes in this study based on the Radiation Therapy Oncology Group (RTOG) criteria. #Intervention - DRUG : Boron-based Gel (Fibore) - During each radiotherapy session, 15 minutes before radiotherapy, the gel used and patients followed up. - Other Names : - Fibore - DRUG : Placebos - During each radiotherapy session, 15 minutes before radiotherapy, the Placebo gel which be free of any chemical used and patients followed up. - Other Names : - No chemical

#Eligibility Criteria: Inclusion Criteria: * Patients who are admitted to the study are enrolled in the study and have head and neck cancer in the breast, and are between the ages of 18 and 75 years and have not received radiotherapy before. Exclusion Criteria: * Pregnant women, patients with unknown dermatitis and those without any willing to participate in this study were excluded. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04239560

{ "NCT_ID" : "NCT01325688", "Brief_Title" : "PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities", "Official_title" : "A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities", "Conditions" : ["Superficial Basal Cell Carcinoma"], "Interventions" : ["Device: Aluminium disk", "Device: OpSite(TM) disk", "Drug: PEP005 (ingenol mebutate) Gel, 0.05%"], "Location_Countries" : ["Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities. #Intervention - DRUG : PEP005 (ingenol mebutate) Gel, 0.05% - PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days - DEVICE : Aluminium disk - DEVICE : OpSite(TM) disk

#Eligibility Criteria: Inclusion Criteria: * Must be male or female and at least 18 years * Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception * Ability to provide informed consent * primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision Exclusion Criteria: * location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area. * Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit. * Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit * Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area. * Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks * Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit. * Use of systemic retinoids. * Those who are currently participating in any other clinical trial * Those known or suspected of not being able to comply with the requirements of the protocol * Females who are pregnant or are breastfeeding Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01325688

{ "NCT_ID" : "NCT02881203", "Brief_Title" : "Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart", "Official_title" : "BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart", "Conditions" : ["Breast Cancer"], "Interventions" : ["Device: Breathe Well", "Device: RPM"], "Location_Countries" : ["Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study investigates the Breathe Well device to test whether it is superior to the existing treatment standard of the Varian Realtime Position Management (RPM) system in assisting patients with deep inspiration breath hold. Detailed Description Recent studies have demonstrated an increased risks of cardiac disease in breast cancer radiotherapy patients. For patients diagnosed \<50 years old, the risks for cardiovascular diseases/events were increased by 24-82% comparing left and right breast radiotherapy. The deep inspiration breath hold (DIBH) technique addresses this problem by reducing the heart dose by up to half, thus potentially reducing the increased rate of major coronary events by 20%. Providing patients with visual feedback in addition to audio guidance has been demonstrated to improve the reproducibility of the DIBH technique by 95% and stability by 80%. Breathe Well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing DIBH for breast cancer patients. #Intervention - DEVICE : Breathe Well - Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment. - DEVICE : RPM - Varian Real-time Position Management (RPM) system

#Eligibility Criteria: Inclusion Criteria: * Left-sided breast cancer patients (invasive and in situ) * Supine positioning of the patients. * Ability to perform a >=20s breath hold * >18 years * An ECOG score in the range of 0 to 2 * Able to give written informed consent and willingness to participate and comply with the study * Patients must be able to read and complete questionnaires in English Exclusion Criteria: * Involvement or at risk regional lymph nodes * Pregnant / lactating women Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02881203

{ "NCT_ID" : "NCT01415089", "Brief_Title" : "Tailored Web-Based Intervention for Cancer Patients and Family Caregivers", "Official_title" : "Tailored Web-Based Intervention for Cancer Patients and Family Caregivers", "Conditions" : ["Breast Cancer", "Colorectal Cancer", "Lung Cancer", "Prostate Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this pilot study is to develop a personalized, interactive, and web-based module for cancer patients and a family caregiver. The three-session module will be designed to help patients and family caregivers improve their communication and support. Detailed Description This R21 will be used to develop an individually tailored, interactive, web-based intervention for cancer patients (lung, colorectal, breast, prostate) and their family caregivers. This intervention is based on an efficacious, family-based program of care (the FOCUS Program) that has been tested previously in three large randomized clinical trials with positive outcomes for patients and their caregivers. In this R21 we will translate this primarily face-to-face, family-based program to an internet-based version. The objectives are: Objective 1. To develop an individually-tailored, interactive, web-based and email-based, Family Involvement Module. We will conduct formative testing while developing the module using qualitative data obtained from four focus groups. We will conduct usability testing of the near final module with data obtained from qualitative interviews with patients and caregivers as they complete web-based task assignments using a 'think aloud' protocol while they navigate the module. Objective 2. To conduct a Phase II study with cancer patients and their family caregiver (N = 40 dyads) using baseline (Time 1) and two-month follow-up assessments (Time 2). Between Times 1 and 2, all participants jointly will complete the web-based Family Involvement Module. We will determine the feasibility of delivering the web-based module and will obtain a process evaluation completed by study participants. Data will be obtained from three large cancer centers using established instruments, and analyzed with descriptive statistics and paired t-tests. Findings from this R21 will provide data that are essential to test this innovative, tailored, interactive web-based intervention with a larger sample in a R01. #Intervention - BEHAVIORAL : FOCUS-Web - A 3-session individually tailored, interactive, web-based program providing support and education for cancer patients and one of their family caregivers. - Other Names : - FOCUS

#Eligibility Criteria: Inclusion Criteria: * cancer patients with confirmed diagnosis of breast, colorectal, lung or prostate cancer * early stage (I or II, diagnosed within past 2 to 12 months) OR advanced stage (III or IV, diagnosed or progressed within past 2 to 12 months) * age >= 18 years * physically/mentally able to participate * speak/read/write English * have access to internet at home * have a family caregiver willing to participate * family caregivers must be age >= 18 years, physically/mentally able to participate, able to speak/read/write English, identified by the patient as his or her primarily family caregiver, and have access to and willing to use the internet. 'Family caregiver' is defined as the family member or significant other identified by the patient as his or her primary source of emotional or physical support during the current cancer experience and confirmed by the designated individual. Exclusion Criteria: * Family caregivers will be excluded from the study if they themselves have been diagnosed with cancer in the previous year or are receiving active treatment for cancer. This criteria was established so all dyads are managing effects of cancer in patients, not the family caregivers. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01415089

{ "NCT_ID" : "NCT00331643", "Brief_Title" : "Ixabepilone in Treating Young Patients With Refractory Solid Tumors", "Official_title" : "Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults With Refractory Solid Tumors", "Conditions" : ["Adult Rhabdomyosarcoma", "Adult Synovial Sarcoma", "Alveolar Childhood Rhabdomyosarcoma", "Childhood Synovial Sarcoma", "Embryonal Childhood Rhabdomyosarcoma", "Previously Treated Childhood Rhabdomyosarcoma", "Recurrent Adult Soft Tissue Sarcoma", "Recurrent Childhood Rhabdomyosarcoma", "Recurrent Childhood Soft Tissue Sarcoma", "Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor", "Recurrent Neuroblastoma", "Recurrent Osteosarcoma", "Recurrent Wilms Tumor and Other Childhood Kidney Tumors"], "Interventions" : ["Drug: ixabepilone"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase II trial is studying how well ixabepilone works in treating young patients with refractory solid tumors. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Detailed Description PRIMARY OBJECTIVES: I. Determine the response rate to ixabepilone in various strata of recurrent solid malignant tumors of childhood and young adulthood, including all of the following: Embryonal or alveolar rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/peripheral neuroectodermal tumor, synovial sarcoma or malignant peripheral nerve sheath tumor, Wilms' tumor, and neuroblastoma. II. Determine the time to progression for each tumor stratum. III. Prospectively evaluate the feasibility and utility of automated volumetric tumor measurement in patients with measurable pulmonary metastases, and descriptively compare volumetric measurements to 1-dimensional (RECIST criteria) and 2-dimensional (WHO criteria) measurements. IV. Define and describe the toxicities of ixabepilone. OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma/ peripheral neuroectodermal tumor vs osteosarcoma vs alveolar or embryonal rhabdomyosarcoma vs Wilms' tumor vs neuroblastoma vs synovial sarcoma/malignant peripheral nerve sheath tumor). Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed up every year for 5 years. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study. #Intervention - DRUG : ixabepilone - Given IV - Other Names : - BMS-247550, epothilone B lactam, Ixempra

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed diagnosis (at original diagnosis or recurrence) of 1 of the following: * Embryonal or alveolar rhabdomyosarcoma * Osteosarcoma* * Ewing's sarcoma /peripheral neuroectodermal tumor* * Synovial sarcoma or malignant peripheral nerve sheath tumor* * Wilms' tumor* * Age <= 21 years at original diagnosis * Neuroblastoma * Age <= 21 years at original diagnosis * Clinically or radiographically measurable or evaluable (by iodine I 123 metaiodobenzoguanine sulfate [^123I-MIBG] or bone scan [evaluable tumors must be positive at >= 1 site]) * If lesion was previously irradiated, a biopsy must be performed >= 6 weeks after completion of radiotherapy and viable neuroblastoma must be demonstrated * No elevated urinary catecholamines and/or bone marrow evidence of tumor with measurable disease clinically or by imaging modalities (CT scan, MRI, ^123I-MIBG, or bone scan) * Refractory or recurrent disease with no known curative treatment options * ECOG performance status (PS) 0 <= age <= 2 OR Karnofsky PS 50 <= age <= 100% (patients > 16 years) OR Lansky PS 50 <= age <= 100% (patients <= 16 years) * Life expectancy >= 8 weeks * No evidence of active graft-versus-host disease * Absolute neutrophil count >= 1,500/mm³ (no growth factors) * Platelet count >= 75,000/mm³ (transfusion independent) * Not pregnant or nursing * Fertile patients must agree to use effective contraception * Negative pregnancy test * Hemoglobin >= 8 g/dL (may receive RBC transfusions) * Creatinine clearance or radioisotope glomerular filtration rate >= 70 mL/min * Bilirubin <= 1.5 times upper limit of normal (ULN) * ALT <= 2.5 times ULN * No clinically significant unrelated systemic illness that would preclude study treatment, including any of the following: * Serious infections * Hepatic, renal, or other organ dysfunction * CNS toxicity <= grade 2 * No pre-existing sensory or motor neuropathy >= grade 2 * Seizure disorder allowed provided it is well controlled by anticonvulsants * No known prior severe hypersensitivity reaction to agents containing Cremophor EL® * Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy * More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks if prior nitrosourea) * At least 7 days since prior biologic agents * At least 2 weeks since prior local palliative (small-port) radiotherapy * At least 6 months since prior craniospinal radiotherapy OR radiotherapy to >= 50% of the pelvis * At least 6 weeks since other prior substantial bone marrow radiotherapy * At least 4 months since prior allogeneic stem cell transplant (SCT) * At least 2 months since prior autologous SCT * No prior taxane (paclitaxel, docetaxel) therapy * More than 1 week since prior growth factor use (except epoetin alfa) * More than 1 week since prior and no concurrent strong inhibitors ofCYP3A4, including any of the following: * Clarithromycin * Troleandomycin * Erythromycin * Ketoconazole * Itraconazole * Fluconazole (doses > 3mg/kg/day) * Voriconazole * Nefazodone * Fluvoxamine * Verapamil * Diltiazem * Amiodarone * Grapefruit juice * More than 1 week since prior and no concurrent enzyme-inducing anticonvulsants, including any of the following: * Carbamazepine * Felbamate * Phenobarbital * Phenytoin * Primidone * Oxcarbazepine * No concurrent aprepitant * No concurrent Hypericum perforatum (St. John's wort) * No concurrent sargramostim (GM-CSF) or interleukin-11 * No other concurrent chemotherapy or immunomodulating agents * No concurrent radiotherapy * Concurrent steroids allowed for pain or chemotherapy-associated nausea or vomiting Sex : ALL Ages : - Minimum Age : 1 Year - Maximum Age : 35 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00331643

{ "NCT_ID" : "NCT00000687", "Brief_Title" : "Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma", "Official_title" : "Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma", "Conditions" : ["Sarcoma, Kaposi", "HIV Infections"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Masking" : "NONE" } }

#Study Description Brief Summary To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens. Detailed Description In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens. Following evaluation studies, patients who participate in the study receive IFN-A2a and AZT. IFN-A2a is administered as a single subcutaneous injection once a day. AZT is given in a single capsule every 4 hours through the day for a total of six capsules. The first phase of treatment continues for 8 weeks followed by a 1-week rest period, during which time AZT only is given. Subjects who have had an interruption in interferon during the first 8 weeks of the study for a toxicity may skip the rest period. Patients experiencing a complete response will be placed on maintenance therapy. Patients without progression of their KS can continue on the treatment of AZT and IFN-A2a until a complete response is obtained or until study is terminated, whichever comes first. Patients with complete anti-tumor response can continue on a maintenance phase, in which they receive IFN-A2a as a single injection 3 times a week on nonconsecutive days and a single capsule of AZT q4h 6 x /day until the study is terminated on February 1, 1992. Patients are required to visit the clinic weekly for the first 12 weeks (except during the week 9 rest period), every other week for the next 8 weeks, every month for up to 52 weeks of the study and every 3 months thereafter. Throughout the study, frequent blood samples will be taken to monitor the effectiveness and safety of the treatment. #Intervention - DRUG : Interferon alfa-2a - DRUG : Zidovudine

#Eligibility Criteria: Inclusion Criteria Concurrent Medication: Allowed: * Inhalation pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) at a dose of 300 mg once every 4 weeks. * AMENDED: Trimethoprim - sulfamethoxazole or dapsone only if on the maintenance phase of the study. Concurrent Treatment: Allowed: * Blood transfusions. Patients must have a positive antibody to HIV by any federally licensed ELISA test. All lab tests must be within 7 days of entry into the study. Exclusion Criteria Concurrent Medication: Excluded: * Other antiretroviral agents. * Immunomodulators. * Corticosteroids. * Cytotoxic chemotherapy. * Aspirin. * H2 blockers. * Barbiturates and myelosuppressive drugs should be particularly avoided as they may interfere with the metabolism or enhance the toxicities of either zidovudine or interferon alfa-2a. * Other experimental medications. Concurrent Treatment: Excluded: * Radiation therapy. Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded from the study. Prior Medication: Excluded: * Interferon therapy. * Excluded within 30 days of study entry: * Immunomodulators. * Corticosteroids. * Cytotoxic chemotherapeutic agents. * Excluded within 14 days of study entry: * Zidovudine (AZT). Prior Treatment: Excluded within 30 days of study entry: * Blood transfusions. * Radiation therapy. Patients may not have any of the following diseases or symptoms: * Active opportunistic infection associated with AIDS. * Significant neurologic disease associated with AIDS, as manifested by motor abnormalities including impaired rapid eye movement or ataxia, motor weakness in the lower extremities, sensory deficit consistent with a peripheral neuropathy, bladder or bowel incontinence. * Internal organ involvement with Kaposi's sarcoma, i.e., nonnodal visceral Kaposi's sarcoma, excluding minimal gastrointestinal disease of less than 5 lesions. * Tumor-associated edema. * Current neoplasm other than Kaposi's sarcoma. * Significant cardiac disease, including a recent history of myocardial infarction or significant current cardiac arrhythmias. Active drug or alcohol abuse. Sex : ALL Ages : - Minimum Age : 12 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00000687

{ "NCT_ID" : "NCT02139358", "Brief_Title" : "Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer", "Official_title" : "Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Gemcitabine", "Drug: Pertuzumab", "Drug: Trastuzumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety and activity of gemcitabine plus trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib. #Intervention - DRUG : Gemcitabine - The Phase I trial will start at the recommended phase II dose (RP2D) for gemcitabine but will have a de-escalation dose levels in the event that an unacceptable toxicity requires dose reduction. Dose level 0 = gemcitabine (1200 mg/m2) IV D1,8 q21 days; Dose level -1 = gemcitabine (1000 mg/m\^2) IV D1,8 q21 days; Dose level -2 = gemcitabine (850 mg/m\^2) IV D1,8 q21 days. The RP2D will be the dose level where 0-1 dose limiting toxicities (DLTs) in six patients occur. - Other Names : - GEMZAR® - DRUG : Trastuzumab - Trastuzumab will be given using an 8 mg/kg loading dose on cycle one, day one (C1D1), followed by 6 mg/kg IV on subsequent cycles every (q) 21 days. - Other Names : - Herceptin® - DRUG : Pertuzumab - Pertuzumab will be given using an 840 mg IV loading dose on C1D1, followed by 420 mg IV on subsequent cycles q 21 days. - Other Names : - PERJETA®

#Eligibility Criteria: Inclusion Criteria: * Adult males or females (aged >= 18 years) with histologically confirmed, metastatic human epidermal growth factor receptor 2 (HER2)+ (by immunohistochemistry (IHC) 3+ or fluorescence in situ hydridization (FISH) ratio >= 2.0) breast cancer * Have progressed on at least one prior line of chemotherapy plus HER2 directed therapy such as trastuzumab and/or pertuzumab in the metastatic setting. T-DM1 would count as a line of therapy and patients previously treated with T-DM1 are eligible. * Have not been treated with gemcitabine in the metastatic setting * Measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status 2<= * Left Ventricular Ejection Fraction (LVEF) >= 50% at baseline as determined by either echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) * Adequate bone marrow function as indicated by the following: absolute neutrophil count (ANC) >1500/µL; Platelets >=100,000/µL; Hemoglobin >10 g/dL * Adequate renal function, as indicated by creatinine <=1.5x upper limit of normal (ULN) * Adequate liver function, as indicated by bilirubin <=1.5x ULN, aspartic transaminase (AST) or alanine transaminase (ALT) <2x ULN unless related to metastatic breast cancer to the liver (in which case AST/ALT < 5x ULN is allowed). * Signed informed consent * Adequate birth control in sexually active women of childbearing potential Exclusion Criteria: * Active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the participant unsafe to proceed with the study * Uncontrolled central nervous system (CNS) metastases. Treated, non-progressing CNS disease (documented by brain magnetic resonance imaging [MRI]) off corticosteroids for at least 1 month potential participants are eligible. * Women who are pregnant or lactating * Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin) * Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation) * Other concomitant active malignancies * History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias * Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower * Hypersensitivity to any of the study medications * Untreated psychiatric conditions preventing informed consent Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02139358

{ "NCT_ID" : "NCT04981223", "Brief_Title" : "Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging", "Official_title" : "Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Device: ExactVu"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools. #Intervention - DEVICE : ExactVu - clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging

#Eligibility Criteria: Inclusion Criteria: * Scheduled for MR-US fusion prostate biopsy or radical prostatectomy * Agree to consent to the study Exclusion Criteria: * Does not agree to consent. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 89 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04981223

{ "NCT_ID" : "NCT01640808", "Brief_Title" : "Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC", "Official_title" : "NIK-333(Peretinoin) PhaseⅢ Study Investigation of the Efficacy and Safety to Suppress Recurrence of Hepatitis C Virus(HCV)-Positive Hepatocellular Carcinoma(HCC), Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group Study", "Conditions" : ["Hepatic Neoplasm Malignant Recurrent"], "Interventions" : ["Drug: Placebo", "Drug: NIK-333(peretinoin)"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the disease, with the recurrence-free survival as the primary endpoint, in a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparison study. #Intervention - DRUG : NIK-333(peretinoin) - 600mg (8 x 75mg capsules) orally, twice a day - DRUG : Placebo - Placebo (8 x Placebo capsules) orally, twice a day

#Eligibility Criteria: Inclusion Criteria: * Patients with HCV-positive HCC who meet the following conditions before radical treatment * Patients diagnosed as having typical HCC on dynamic CT,CTA/CTAP, or dynamic MRI (nodule visualized as a high signal intensity area in the arterial phase and as a relatively low signal intensity area in the portal and equilibrium phases) performed within 8 weeks (56 days) before treatment start prior to radical therapy * Patients with the first primary HCC or the first recurrence of primary HCC * Patients who received the radical therapies. The treatment duration (from the start to the end of the treatment) should be within 4 weeks (28 days) for each of the radical therapies. * Patients showing a complete cure, as confirmed by the dynamic CT images taken from 8 weeks (56 days) to 12 weeks (84 days) after the end of the treatment show a non-stained low-concentration area overlapping the tumor image observed before complete cure. * Patients who are able to begin treatment with the study drug within 8 weeks (56 days) after dynamic CT to confirm complete cure * Patients confirmed of satisfying the following conditions based on the screening performed at subject registration * Positive for serum hepatitis C virus nucleic acid (HCV-RNA) * Grade A on Child-Pugh classification * Platelet count of 50 000/µL or higher * Patients with ECOG Performance Status score of 0 to 1 * Patients of the age of >= 20 years at the time of informed consent Exclusion Criteria: * Patients positive for HBs antigen * Patients showing vascular invasion of HCC on imaging diagnosis * Patients who have also undergone transcatheter arterial embolization therapy (TAE/TACE), transarterial infusion therapy (TAI), and chemolipiodolization in combination with the radical therapy * 4 Patients who want to receive antiviral therapy such as concomitant therapy with intaferon during the study period * Patients who have received other study drugs, anticancer drugs, or interferons after radical therapy * Patients who have hypertension as a complication, and whose blood pressure cannot be controlled by drug therapy (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, as determined at subject registration) * Patients who have a history of allergy to CT contrast media, and whose participation in this study is judged to be inappropriate by the investigator or the subinvestigator * Patients with a history of total gastrectomy * Patients with a history of cardiac arrest * Patients with any of the following laboratory values or complications * Creatinine>= 1.5mg/dL * Albumin urine >= 1000mg/g Creatinine * Cardiac disorder corresponding to CTC-AE grade 3 in severity * HbA1c >= 7.4 under treatment with insulin * Autoimmune disease or asthma being treated with oral steroid * Patients confirmed of having another malignant neoplasm or who had undergone a radical therapy of HCC within the past 5 years to treat another malignant neoplasm (however, this does not apply to endoscopic resection and resection of intraepithelial carcinoma) * Patients who are pregnant, who have a possibility of being pregnant or who have a desire to become pregnant during the study period * Lactating women * Patients who have a history of allergy to retinoid-related substances (vitamin A, etc.) in the past * Patients who participated in another clinical study within past 6 months Sex : ALL Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01640808

{ "NCT_ID" : "NCT02677142", "Brief_Title" : "Evaluating the Efficacy of a Group Social Skills Intervention", "Official_title" : "A Randomized Control Trial to Evaluate the Efficacy of a Group Social Skills Intervention for Childhood Survivors of Brain Tumours", "Conditions" : ["Brain Tumours"], "Interventions" : ["Behavioral: Structured social skills training program, SSIP", "Behavioral: CG - social skills activities"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Tumours affecting the brain are a very heterogeneous group of diseases. Accordingly, treatment strategies vary widely depending on child's age, tumour location, its resectability and histology. As a group, however, the survival rate of childhood brain tumors has improved in recent years, resulting in an increased number of survivors returning to school and reintegrating into their communities. Survival for many of them, however, has also come with severe costs such as neurocognitive and academic difficulties. Cognitive rehabilitation strategies to address these deficits have been a major focus of recent research. Evidence is now also mounting for social competence deficits among this population which may persist into late adolescence and adulthood, thereby negatively affecting long-term survivorship. Thus, there is an urgency to identify psychosocial interventions, such as social skills programs, that can reduce the social competence deficits in childhood brain tumor survivors and, therefore, modify the course of these outcomes to ensure that survivors thrive and become productive members of society. To date, no rigorous social skills intervention trials have been undertaken to address the social difficulties of these survivors. The current proposal is the first study that aims to address this gap by evaluating the efficacy of an innovative, manualized, social skills intervention program developed for this population using a multi-centre Randomized Control Trial (RCT). Detailed Description Children and adolescents who are treated for brain tumours are faced with a variety of problems that affect the way they live their lives: one of the biggest problems is limited contact with friends and peers. This study aims to help kids and teens deal with this problem. The purpose of this study is to give kids who are treated for brain tumors opportunities to meet with other kids with similar experiences by participating in one of two social skills groups to improve how they related to one another. Investigators are assessing if these programs are beneficial to kids who have had brain tumours and which group is best. Kids will be assigned randomly to one of two groups. In both groups kids will meet with the other participants and with the facilitators for two hours once a week for 8 weeks. Kids in both groups will have introductions, group rules and group purpose (learn to relate with one another) through fun with games and arts and crafts. In one group, the games and crafts will be used for learning social skills. In the other group, arts and crafts and playing will be the focus of the activities, with the goal for each session determined by creating a craft or playing a game where everyone can win. One parent and all kids will complete questionnaires before the group starts, after the last group session as well as 6 months following the group. The questionnaires will ask questions about feeling, actions and getting along with others. Investigators also plan to visit the child's school so that the child, classmates and teachers will fill out questionnaires about friendships. #Intervention - BEHAVIORAL : Structured social skills training program, SSIP - Detailed, session by session, in the manual written for this purpose. It addresses six major social skills, one per session, starting with easier skills (Social Initiation and Friendship Making, Cooperation) and moving towards more complex skills (Managing Teasing and Bullying, Conflict Resolution, Empathy, and Assertion). - BEHAVIORAL : CG - social skills activities - Sessions will not be designed around a specific social skill and activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with a brain/spinal tumour * off treatment for at least 3 months or on maintenance chemotherapy but medically stable, e.g., low grade gliomas * between 8 and 16 years at the time of enrollment * have sufficient fluency in English for active group participation * attending school regularly and in a regular classroom for at least 50% of a school day Exclusion Criteria: * Severe cognitive deficits, as defined by enrollment in full-time special classroom, which will prevent them from participating fully * a diagnosis of conduct disorder or any other condition that may interfere with group activities. Survivors and parents who have some difficulties reading (i.e., English is their second language) will be assisted by a research assistant (RA) in completing the questionnaires. Sex : ALL Ages : - Minimum Age : 8 Years - Maximum Age : 16 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT02677142

{ "NCT_ID" : "NCT00073736", "Brief_Title" : "Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma", "Official_title" : "A Phase 1/2 Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MB07133 in Subjects With Unresectable Hepatocellular Carcinoma and Child-Pugh Class A Liver Function", "Conditions" : ["Hepatocellular Carcinoma"], "Interventions" : ["Drug: MB07133 1800 mg/m2/day", "Drug: MB07133 2400 mg/m2/day", "Drug: MB07133 300mg/m2/day", "Drug: MB07133 1200 mg/m2/day", "Drug: MB07133 600 mg/m2/day"], "Location_Countries" : ["Taiwan", "Hong Kong", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for this study is to determine the safety and tolerability of MB07133. Detailed Description To determine the maximum tolerated dose of MB07133 when administered as a 7-day continuous i.v. To characterize the safety profile and the pharmacokinetics of MB07133 and metabolites during and after continuous infusion. To determine the effect of MB07133 on hepatocellular carcinoma (HCC) tumor size. #Intervention - DRUG : MB07133 300mg/m2/day - 7-day continuous infusion in 28-day cycles - DRUG : MB07133 600 mg/m2/day - 7-day continuous infusion in 28-day cycles - DRUG : MB07133 1200 mg/m2/day - 7-day continuous infusion in 28-day cycles - DRUG : MB07133 1800 mg/m2/day - 7-day continuous infusion in 28-day cycles - DRUG : MB07133 2400 mg/m2/day - 7-day continuous infusion in 28-day cycles

#Eligibility Criteria: Inclusion Criteria: * Patients with a diagnosis of local unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. 'Local' is defined as disease either restricted to the liver or contiguous with the liver and no identifiable extrahepatic disease. * Patients with Child-Pugh Class A liver function. For purposes of this trial, an eligible patient must not have Encephalopathy or Ascites and the total Child-Pugh score cannot be greater than 6 at baseline * Males or females 18 years or older * Ability to provide written informed consent before initiation of any study-related procedures and ability, in the opinion of the Principal Investigator, to comply with all the requirements of the study * Male and female subjects who are surgically sterile, who remain abstinent, or who agree to practice double barrier forms of birth control from screening through 30 days (females) and 90 days (males), from the last dose of study medication Exclusion Criteria: * History of or presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, GI, pulmonary, immunological (with the exception of the presence of hepatitis B virus [HBV], HCV hepatitis, or cirrhosis), endocrine, or central nervous system disorders * Patient has a history of cancer other than hepatocellular (excluding resected basal cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for 5 years or more). * Patients with distant metastasis or extrahepatic disease * An Eastern Cooperative Oncology Group (ECOG) performance status score of greater than or equal to 2 * Current encephalopathy or current treatment for encephalopathy * History of drug or alcohol abuse within 6 months before screening * History of, or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent * A documented variceal hemorrhage within 4 months of screening * Neutrophil count less than or equal to 1,500/mm3, platelet count less than or equal to 100,000/mm3, hemoglobin less than or equal to 8.5 g/dL, or a Prothrombin Time (INR) greater than 1.3 (vitamin K supplementation allowed) * Serum creatinine greater than 1.1 times the upper limit of normal * History of human immunodeficiency virus or acquired immune deficiency syndrome * Use of an investigational drug or product or participation in a drug study within 30 days before dosing * Liver function defined as: serum bilirubin greater than 1.5 times the upper limit of normal or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, or serum albumin less than 3.2 g/dL * History of gout or abnormal uric acid metabolism * The clinical presence of ascites * Treatment of HCC within 30 days of screening by chemotherapy or treatment of the target lesion(s) by chemoembolization, PEI, or surgery * Radiofrequency ('RF') ablation of the target lesion(s) within 60 days of screening * Subjects with a life expectancy of less than 12 weeks * Subjects having received an organ transplant * Subjects currently receiving coumadin or heparin * Pregnant or nursing women Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00073736

{ "NCT_ID" : "NCT01845805", "Brief_Title" : "Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine)", "Official_title" : "A Phase II Trial to Improve Outcomes in Patients With Resected Pancreatic Adenocarcinoma at High Risk for Recurrence Using Epigenetic Therapy", "Conditions" : ["Pancreatic Cancer"], "Interventions" : ["Other: Observation", "Drug: oral azacitidine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To improve progression free survival in high risk patients with resected pancreatic adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of adjuvant therapy. Detailed Description This trial is for patients with resected pancreatic adenocarcinoma who have concluded adjuvant therapy or were deemed unable to receive adjuvant therapy with an elevated CA19-9 or node positive or margin positive disease. CA 19-9 elevation is defined as two levels \> the institutional upper limit of normal (ULN) taken at least 2 weeks apart. These levels should be measured after adjuvant therapy has concluded or upon the decision that adjuvant therapy will not be offered. Patients will be randomized to one of two arms. Subjects enrolled due to node positive disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA19-9 elevation can enroll any time after adjuvant therapy has completed. Arm A, the treatment arm, will be started on CC-486. Arm B, the control arm, will receive no additional therapy. In both arms, CA19-9 will be followed and CT scans (or MRI, if clinically indicated) will be done every three months. When patients have visible disease recurrence on imaging, CC-486 will be stopped and both groups will start first-line chemotherapy. #Intervention - DRUG : oral azacitidine - Other Names : - CC-486 - OTHER : Observation

#Eligibility Criteria: Inclusion Criteria: * Understand and voluntarily sign an informed consent form. * Age greater than or 18 years at the time of signing the informed consent form. * Able to adhere to the study visit schedule and other protocol requirements. * Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R0 (negative margins) or R1 (microscopically positive margins) resection. * Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy. Although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy ± radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria. * Subjects enrolled due to node + disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA 19 <= age <= 9 elevations can enroll any time after adjuvant therapy has completed. * All previous cancer therapy including radiation, chemotherapy, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study * Subjects must either have a CA 19 <= age <= 9 value > the institutional ULN on two separate checks at least 2 weeks apart OR have had an R1 resection margin OR N1 nodal disease regardless of CA 19 <= age <= 9 level * Subjects must be free of visible disease on imaging (CT, PETCT or MRI) evaluating chest, abdomen, and pelvis within 28 days of enrollment on the study. * Life expectancy of greater than 12 weeks * ECOG performance status of less than or equal to 1 at study entry * Subjects must have normal organ and marrow function * Free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast. * Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC-486 or nab-paclitaxel. All men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment. * Women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening. * Subjects must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE) Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or breastfeeding women. * Use of any other chemotherapy, radiotherapy, or experimental drug or therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment on study or those who have not recovered from adverse events >= grade 1 due to agents administered more than 4 weeks earlier except for stable grade 2 neuropathy. * Subjects may not receive any other concomitant investigational agents. * Known or suspected hypersensitivity to 5-azacitidine or mannitol * Known positive for HIV or infectious hepatitis, type B or C. HIV patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01845805

{ "NCT_ID" : "NCT04685811", "Brief_Title" : "Evaluation of PSMA Antagonist Produced by Two Different Methods", "Official_title" : "Evaluation of a 68Ga Small Molecule PSMA Antagonist Produced by Two Different Methods", "Conditions" : ["Metastatic Prostate Adenocarcinoma"], "Interventions" : ["Drug: 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent. Detailed Description Patients with metastatic prostate adenocarcinoma will be enrolled in the study and will undergo two 68Ga-Prostate Specific Membrane Antigen- Positron Emission Tomography (PSMA-PET) scans within 24-48 hours. The difference between the two scans is that the radiotracer used in each scan will be produced with a different method (68Ga-PSMA-cyclotron and 68Ga-PSMA-generator produced). The first scan will occur after a baseline clinical evaluation, which will include a history, physical, and baseline lab draw. After each scan, blood draws will be obtained. The purpose of this study is to evaluate equivalence of two processes to create 68Ga-HBED-PSMA and compare dosimetry, biodistribution and whole body excretion/ metabolism. Furthermore, the research team will perform dynamic analysis of the PET scans to investigate repeatability of whole-body 68Ga-PSMA-generator Ki Patlak imaging against that of conventional whole-body 68Ga-PSMA- SUV imaging and evaluate equivalence of whole-body 68Ga-PSMA Ki Patlak imaging between the two processes to create 68Ga-HBED-PSMA (68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator). Patients will afterwards receive standard of care treatment and follow up imaging. #Intervention - DRUG : 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron - 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron; single dose each, approximately 100-300 mBq. - Other Names : - Prostate specific membrane antigen imaging (PSMA)

#Eligibility Criteria: Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled in this study: * Aged >= 21 years and below 80 years * Signed written informed consent and willingness to comply with protocol requirements * Histologically confirmed diagnosis of metastatic prostate cancer * Staging imaging exam confirming metastatic disease, e.g. total body MRI, or CT chest/abdomen/pelvis, 99mTc bone scan, NaF PET Exclusion Criteria: * Laboratory values: * Serum creatinine >2.5 mg/dL * AST (SGOT) >2.5x ULN * Bilirubin (total) >1.5x ULN * Serum calcium >11 mg/dL * Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject. * Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements. * Other severe acute or chronic medical condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and in the judgment of the investigator, would make the patient inappropriate for entry into this study. * Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia. Sex : MALE Ages : - Minimum Age : 21 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04685811

{ "NCT_ID" : "NCT00787527", "Brief_Title" : "SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma", "Official_title" : "A Phase I/II of Vorinostat Plus CHOP in Untreated T-cell Non-Hodgkin's Lymphoma", "Conditions" : ["Lymphoma"], "Interventions" : ["Drug: Vincristine", "Drug: Zolinza (vorinostat)", "Drug: Doxorubicin", "Drug: Prednisone", "Drug: Cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this clinical research study is to find out how well the drug Zolinza (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell Non-Hodgkin's Lymphoma (NHL). The safety of these drugs in combination and the best dose of vorinostat when given in combination with CHOP will also be studied. Detailed Description The Study Drugs: Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die. Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth. This may cause the cancer cells to die. Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth. This may cause the cancer cells to die. Prednisone is designed to decrease inflammation by preventing white blood cells from completing an inflammatory reaction. This drug can cause lymphocytes, a type of white blood cell, to break apart and die. Study Drug Administration: If you are found to be eligible to take part in this study, you will begin to take vorinostat on the first day of treatment which is Day -1. Vorinostat capsules are taken by mouth, either 3 times a day or 2 times a day, depending on what the study doctor thinks is in your best interest. If you are taking vorinostat 3 times a day, it should be taken in the morning, afternoon and evening. If you are taking vorinostat 2 times a day, you will take the capsules in the morning and evening. The capsules must be taken with food (within 30 minutes after a meal). You will receive the vorinostat capsules on the first day of each cycle. You will also receive instructions on how to take the drug. You should return any unused vorinostat capsules back to study staff at the end of each cycle. You will take vorinostat for 5 days (Days -1 through 3) of each cycle and then beginning on Day 1, cyclophosphamide, vincristine, and doxorubicin will be given though a needle in your vein. This will happen for each 21-day study cycle. Cyclophosphamide is given over 1 hour. Vincristine is given over 15 minutes. Doxorubicin is also given over 15 minutes. The starting dose of vorinostat may change On Days 1-5 of each cycle, you will take prednisone tablets by mouth. If you begin to experience severe or intolerable side effects, the study drug schedule may be stopped for up to 3 weeks. If the side effects improve, you may be able to receive the study drugs again, with either a lower dose of vorinostat or if you are taking vorinostat three times daily, you may take it twice a day instead. The chemotherapy drugs (cyclophosphamide, doxorubicin, vincristine, and prednisone) may also be lowered depending on what side effects are being experienced. If you continue to have severe or intolerable side effects with the lower dose of vorinostat and chemotherapy, you will taken off study. Study Visits: On Day 1 of all cycles, the following tests and procedures will be performed: * Your medical history will be recorded, including any drugs that you are taking. * You will be asked about any side effects you may have experienced. * You will have a physical exam, including measurement of your vital signs and weight. * Blood (about 5 teaspoons) will be drawn for routine tests. * Your performance status will be recorded. On Day 1 of Cycle 2 you will have an ECG. On or before Day 1 of Cycle 3 the following tests and procedures will be performed if your doctor thinks necessary: * You will have CT and/or PET scans to check the status of the disease. * You may have a bone marrow aspirate and/or biopsy to check the status of the disease. Length of Study: You will receive the study drugs for up to 6 cycles. You may be taken off study early if the disease gets worse or if severe or intolerable side effects occur. End-of-Study Visit: If you go off study treatment for any reason, you will have an end-of-study visit within 4 weeks after your last dose of study drugs or before starting a new treatment. At this visit, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs. * Your performance status will be recorded. * You will be asked about any side effects you may have experienced. * Blood (about 5 teaspoons) will be drawn for routine tests. * You will have CT scans and PET scans to check the status of the disease. * If you had skin lesions when you began the study, the skin lesions will be photographed. * If the doctor thinks it is needed, you will have bone marrow biopsy and/or aspirate. Follow-up Visits: After you are off study treatment, you will have follow-up visits. You will go to these visits every 3 months for the1st year, every 4 months for the 2nd and 3rd years, and every 6 months for the 4th and 5th years. After this, you will return 1 time each year unless the lymphoma returns. The following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs. * Your performance status will be recorded * You will be asked about any side effects you may have experienced. * Blood (about 5 teaspoons) will be drawn for routine tests. * You will have CT scans and PET scans to check the status of the disease. * If you had skin lesions when you began the study, the skin lesions will be photographed. * If the doctor thinks it is needed, you will have bone marrow biopsy and/or aspirate. This is an investigational study. Vorinostat is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma that has not come back or not responded to prior therapy. CHOP is currently FDA approved for treatment of patients with NHL. The use of vorinostat in combination with CHOP in patients with T-cell NHL is investigational. Up to 52 patients will take part in this study. All will be enrolled at MD Anderson. #Intervention - DRUG : Zolinza (vorinostat) - Up to two 100 mg capsules of Vorinostat (dosage will vary from 100 mg orally (PO) twice daily (BID), 300 mg PO every evening and 200 mg PO BID with the starting dose at 300 mg PO every evening for the phase I trial) are to be administered orally twice daily (once in the morning and once in the evening, or if in the daily dosing cohort once in the evening) in repeated 21-day cycles consisting of 10 days dosing starting on days 5 through 14 followed by a 7-day rest period, during which no vorinostat will be administered. - Other Names : - vorinostat, SAHA, Suberoylanilide Hydroxamic Acid, MSK-390 - DRUG : Cyclophosphamide - 750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle - Other Names : - Cytoxan, Neosar - DRUG : Doxorubicin - 50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle - Other Names : - AD, Hydroxydaunomycin hydrochloride - DRUG : Vincristine - 1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle - DRUG : Prednisone - 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle

#Eligibility Criteria: Inclusion Criteria: * Patients must have a new diagnosis of T-cell NHL eligible histologies include:Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma (ALK) (ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, intestinal T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma. * Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk. A minimum of four cycles of therapy will be given before evaluation for to hematopoetic stem cell transplant. * Patients must have biopsy proven disease which can include bone marrow and/or lymph node (cutaneous only disease is excluded) * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Patients must be age 18 years and above.There is no dosing or adverse event data are currently available on the use of vorinostat in patients <18 years, children are excluded from this study but may be eligible for future pediatric phase 2 combination trials. * There is Patients are required to have adequate bone marrow reserve as indicated: Absolute neutrophil count (ANC) >= 1000/mm^3, Platelets >= 50,000/mm3, Hemoglobin >= 8g/dL. If there is bone marrow involvement by lymphoma then there is no minimum level of counts required. * Patients must have adequate liver function as indicated by: Bilirubin <= 1.5 times the upper limit of normal (ULN), Alanine transaminase (ALT) <=2 times the (ULN) or aspartate transaminase (AST) <= 2 times the ULN. These values must be obtained within two weeks before protocol entry. * Patients are required to have adequate renal function as indicated by a serum creatinine <= 2.5 mg/dL. This value must be obtained within two weeks before protocol entry. * Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >= 50%. * Concomitant steroids may continue provided they are being used for symptom management and not for treatment of lymphoma. * Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study * Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized). * Female patients of childbearing potential must have a negative serum pregnancy test (Beta human chorionic gonadotropin (hCG)) within 72 hours of receiving the first dose of vorinostat. * Patients must have the ability able to give informed consent. Exclusion Criteria: * 1. Patients with a) T-cell lymphoma with skin involvement only are excluded if they have no evidence of systemic disease b)T-cell prolymphocytic leukemia (T-PLL) c) T-cell large granular lymphocytic leukemia d) Primary cutaneous CD30+ disorders: anaplastic large cell lymphoma and lymphomatoid papulosis e) Angiocentric/nasal type T/Natural Killer (NK)-cell lymphoma f) Hepatosplenic gamma-delta T-cell lymphoma * Patients with active Hepatitis B and/or Hepatitis C infection. * Patients with known HIV infection are excluded. a) These patients are excluded secondary to potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy. * Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved. * Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes:a) Congestive heart failure, b) Severe CAD, c) Cardiomyopathy, d) Uncontrolled cardiac arrhythmia, e) Unstable angina pectoris, f) Recent MI (within 6 months). * Patients with prior exposure to either vorinostat (including other histone deacetylase (HDAC) inhibitors except valproic acid) or anthracyclines: a) Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment. * Patients who are pregnant or breast-feeding. a)Effects of this treatment on the fetus and young children are unknown at this time. * Patients who have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast who is currently without evidence of disease. * Patients undergoing anti-neoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within the past four weeks. * Patients with deep vein thrombosis within three months. * Patient with concurrent use of complementary or alternative medicines. * Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements. * Patients with grade 2 or more neuropathy. * Patients with known central nervous system (CNS) lymphoma. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00787527

{ "NCT_ID" : "NCT02235142", "Brief_Title" : "Prostatic Cancer Versus Androgen Deficiency", "Official_title" : "Localised Cancer of Prostate and Androgen Deficiency.", "Conditions" : ["Cancer of Prostate"], "Interventions" : ["Other: Blood sample"], "Location_Countries" : ["France", "Guadeloupe", "Martinique"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Open study to make a comparison between hypogonadism and euogonadism patients regarding the severity of prostate cancer. The purpose of this study is to determine the importance of the relationship between the hormonal status and the type of the tumor at the time of surgical intervention as well as follow up of the patients. #Intervention - OTHER : Blood sample

#Eligibility Criteria: Inclusion Criteria: * Male patients over than 18 years, with localized, stage I or II prostate cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,...) or hormonal therapy, showing indication of radical prostatectomy. Exclusion Criteria: * Absence of radical prostatectomy indication * Patient received local or hormonal therapy prior to surgery * Patients already enrolled in other clinical study incompatible with the study * Patients on a treatment which can affect hormonal level (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride) Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02235142

{ "NCT_ID" : "NCT01478685", "Brief_Title" : "A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors", "Official_title" : "A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors", "Conditions" : ["Urinary Bladder Neoplasms", "Carcinoma, Transitional Cell", "Ovarian Neoplasms", "Fallopian Tube Neoplasms", "Peritoneal Neoplasms", "Carcinoma, Non-Small-Cell Lung", "Carcinoma, Pancreatic Ductal", "Tumor Virus Infections"], "Interventions" : ["Drug: ABI-007", "Drug: Carboplatin", "Drug: CC-486"], "Location_Countries" : ["France", "Netherlands", "Spain", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in subjects with relapsed or refractory solid tumors. #Intervention - DRUG : CC-486 - CC-486 will be administered orally at doses between 100-300 mg daily for either 14 or 21 days depending on tolerability - Other Names : - Oral Azacitidine - DRUG : Carboplatin - Carboplatin will be given by intravenous (IV) infusion once every 21 Days at a dosage of AUC x 4. - Other Names : - Paraplatin - DRUG : ABI-007 - ABI-007 will be administered by intravenous (IV) infusion on two of every three weeks at a dosage of 100 mg/m\^2 - Other Names : - nab-paclitaxel, Abraxane

#Eligibility Criteria: Inclusion Criteria: * Men and women, >= 18 years at the time of signing the Informed Consent Document (ICD). * Understand and voluntarily sign an ICD prior to any study-related assessments or procedures are conducted. * Able to adhere to the study visit schedule and other protocol requirements. * With histological or cytological confirmation of advanced unresectable solid tumors, including those who have progressed on (or not been able to tolerate) standard anticancer therapy, or for whom no other effective therapy exists, or for who declines standard therapy. * Consent to screening tumor biopsy (for accessible tumors when appropriate [optional in Part 1, mandatory in Part 2]). * Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2. * The following laboratory values: * Absolute neutrophil count (ANC) >= 1.5 X 10^9/L * Hemoglobin (Hgb) >=90 g/L * Platelets (plt) >= 100 x 10^9/L * Potassium within normal range, or correctable with supplements; * AST and ALT <=2.5 x Upper Limit Normal (ULN) or <=5.0 x ULN if liver tumor is present; * Serum total bilirubin <= 1.5 x ULN * Serum creatinine <= 1.5 x ULN, or 24-hr clearance >= 60ml/min; and * Negative serum pregnancy test within 7 days before starting study treatment in females of childbearing potential (FCBP) * Females of child-bearing potential {defined as a sexually mature women who * has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or, * has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months} must * agree to the use of a physician- approved contraceptive method (oral, injectable, or implantable hormonal contraceptive ; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on oral azacitidine and for 3 months following the last dose of study medication; and * have a negative serum pregnancy test during screening * Male subjects with female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study to avoid fathering a child during the course of the study and for 6 months following the last dose of oral azacitidine. The criteria below are in addition to or supersede the Part 1 inclusion criteria above: * With histological or cytological confirmation of relapsed or refractory advanced unresectable solid tumors as listed below for each Arm, including those who have progressed on or were unable to tolerate standard anti-cancer therapy. * Arm A: CC-486 plus CBDCA: * Relapsed or refractory urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra (mixed histologies are permitted provided a component of urothelial carcinoma is present) * Epithelial ovarian, fallopian tube, or primary peritoneal carcinoma * Arm B: CC-486 plus ABI-007: * NSCLC * Pancreatic carcinoma * Arm C: CC-486 single agent: * Virally-associated tumors - tumor types known to be driven by Epstein-Barr Virus (EBV), Human Papilloma Virus (HPV), and Merkel cell carcinoma of the skin (MC Polomavirus) * Nasopharyngeal carcinoma (a minimum of 5 subjects) * Cervical carcinoma * Anal carcinoma * Merkel cell carcinoma (MCC) * Note: Hepatitis B virus (HBV) and Hepatitis C virus (HCV)-associated tumors (hepatocellular cancers) are not eligible. * Note: Head and neck squamous cell cancers (HNSCC) must have HPV-positive status documented to be eligible * Subjects with documented liver metastases must have serum albumin >= 3 g/dL; * Sites of disease (primary or metastatic) that are, in the opinion of the investigator, accessible for biopsy without undue risk to the subject * Consent to tumor biopsy at screening (prior to the first dose of CC-486) and at Cycle 1 Day 15. * Measurable disease according to RECIST v1.1. Exclusion Criteria: * Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. * Any condition that confounds the ability to interpret data from the study. * Symptomatic central nervous system metastases. Subjects with brain metastases that have been previously treated and are stable for 6 weeks are allowed. * Known acute or chronic pancreatitis. * Any peripheral neuropathy >= NCI CTCAE grade 2. * Persistent diarrhea or malabsorption >= NCI CTCAE grade 2, despite medical management. * Impaired ability to swallow oral medication. * Unstable angina, significant cardiac arrythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure. * Prior systemic cancer-directed treatments or investigational modalities <= 5 half lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy. (except alopecia). * Major surgery <= 2 weeks prior to starting a study drug or who have not recovered from side effects of such therapy. * Pregnant or breast feeding. * Known Human Immunodeficiency Virus (HIV) infection. * Known chronic hepatitis B or C virus (HBV/HCV) infection, unless this is a comorbidity in subjects with HCV. * Liver metastases with serum albumin < 3 g/dL. * Other prior cancers within previous 5 years except adequately treated in situ carcinoma cervix, or basal, or squamous carcinoma of the skin. * Subjects with > 4 prior systemic chemotherapy regimens will require approval by the Celgene Medical Monitor prior to enrollment. A regimen is defined as >= 2 cycles of systemic anti-cancer therapy containing 1 or more agents in the following classes: topoisomerase 1 or 2 inhibitors, platinum salts, alkylating agents, tubulin inhibitors, anti-metabolites or vinca alkaloids. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01478685

{ "NCT_ID" : "NCT03778047", "Brief_Title" : "A Study Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch", "Official_title" : "A Clinical Study for Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer", "Conditions" : ["Metastatic Castration Resistant Prostate Cancer"], "Interventions" : ["Drug: Enzalutamide", "Drug: HC1119"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and related changes after drug switch in Chinese patients with metastatic castration-resistant prostate cancer. The study primary objective is to evaluate the pharmacokinetic characteristics of enzalutamide in Chinese patients with mCRPC. #Intervention - DRUG : Enzalutamide - oral - DRUG : HC1119 - oral

#Eligibility Criteria: Inclusion Criteria: * Voluntarily participated in the study, with understanding of and will to comply with relevant study procedures and signed informed consent form; * Chinese male, >= 18 years; * With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma; * With evidence of metastatic lesions (such as bone scan and CT/MRI); * Patients with relapsed, refractory, or progressive disease despite castration (surgery or chemical) or combined androgen deprivation therapy. (Progressive disease is defined as 1 or more of the following 3 criteria: PSA progression: A minimum of 3 rising PSA values with an interval of at least 1 week between determinations, resulting in a final value higher than 50% of the minimum, with a starting PSA value > 2 ng/ml; Soft tissue disease progression as defined by RECIST 1.1; Bone progression as defined by PCWG2 with 2 or more new lesions on bone scan); * Castrate levels of testosterone (< 50 ng/dl) at screening; bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues; * ECOG performance status <=1; * Laboratory tests must meet the following criteria: 1. Routine Blood Test: hemoglobin (Hb) >= 90g/L (no blood transfusions within 14 days prior to screening); absolute neutrophil count (ANC) >= 1.5 x 109/L; Platelet Count (PLT) >= 80 x 109/L; 2. Blood Biochemistry: creatinine (Cr) <= 2 x upper limit of normal (ULN), or Cr > 2 x ULN but the calculated CrCl >= 60 ml/min; bilirubin (BIL) <=2 x ULN; alanine aminotransferase (ALT), aspartate aminotransferase (AST) <=2.5 x ULN (or <= 5.0 x ULN for patients with liver metastases); 3. Coagulation: INR < 1.5. * Estimated life expectancy > 6 months. Exclusion Criteria: * Participated in other clinical drug trials within 1 month prior to screening, or the occurrence of toxicity caused by previous treatments that has not been relieved to <= Grade 2 toxicity (according to CTCAE 4.03) prior to enrollment; * Brain metastases; * Subjects are excluded if any of the following conditions are met: 1. Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer); 2. History of organ transplants; 3. Past medical history of seizures, serious CNS diseases, or unexplained coma, family history of seizures, or history of traumatic brain injury; 4. Uncontrolled hypertension (systolic >= 160 mmHg or diastolic >= 100 mmHg) or other serious cardiovascular diseases. (Patients with a history of hypertension is eligible if his blood pressure is controlled with antihypertensives); 5. Significant GI dysfunction which may affect the intake, transport, or absorption of drug (such as inability to swallow, chronic diarrhea, and bowel obstruction, etc.), or patients with complete gastrectomy; 6. Other uncontrolled clinical diseases, including but not limited to: persistent or active infections. * Subjects are excluded if any of the following conditions regarding past or concomitant medication are met: 1. Medications that lower the seizure threshold must be used during the trial; 2. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or cyproterone within 4 weeks prior to screening; 3. Treatment with ketoconazole within 4 weeks prior to screening; 4. Previously treated with investigational or approved medications that inhibit testosterone synthesis (such as abiraterone acetate, TAK-683, and TAK-448) or target testosterone receptors (such as SHR3680, proxalutamide, and ARN509), except for bicalutamide and flutamide. * Known hypersensitivity to any ingredient of the study drugs (enzalutamide and HC-1119) or similar drugs; * HIV seropositive; * History of medication or drug abuse; * Other conditions that subject is determined by the investigator to be unsuitable for this study. Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03778047

{ "NCT_ID" : "NCT03595540", "Brief_Title" : "Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment", "Official_title" : "Phase II Clinical Study of a Fasting-mimicking Diet in Patients Undergoing Oncologic Treatment", "Conditions" : ["Cancer", "Breast Cancer", "Colorectal Cancer"], "Interventions" : ["Other: Prolon"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a pilot, single arm prospective trial assessing feasibility, safety and effects on patient nutritional status of a 5-day fasting-mimicking diet (FMD) in patients with different cancer types and concomitant anticancer treatment. Detailed Description It is proposed to conduct a single-arm phase II clinical study of a FMD (Prolon, by L-Nutra) in 60 patients with solid or hematologic tumors who undergo treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biological drugs (including trastuzumab, pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (e.g. Opdivo, Keytruda). Prolon is a FMD lasting five days. It consist of vegetable soups, broths, bars, olives, crackers, herbal teas, supplements of vitamins and minerals. Day 1 of the FMD supplies \~4600 kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide \~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day. Primary endpoints of the study are the feasibility and safety of monthly cycles of the FMD in patients with solid or hematologic tumors who undergo active treatment. Feasibility is monitored through the compilation of a food diary and is defined as the strict adherence to the diet prescribed in all its days with the possibility of admitting the consumption of only 50% of the planned diet and / or a maximum consumption of 4-5 Kcal / kg body weight of food not provided in only one of the five days of each cycle. Furthermore, the dosage of IGF-1 and of urinary ketone bodies allow to identify further cases of non-adherence to the diet. FMD-emergent side effects are monitored according to the NCI-CTCAE version 5.0. Secondary endpoints include: * patient nutritional status as monitored by weight, handgrip strength, bio-impedance and serum markers (ferritin, transferrin, colinesterase). * Quality of life (QLQ-C30) * Clinical responses measured by CT, MRI or by blood chemistry tests, dosing of tumor markers and / or molecular biology tests in the case of prostate tumors or hematologic tumors (e.g. PSA in patients affected by prostate cancer, BCR / Abl mRNA in the case of patients undergoing treatment with kinase inhibitors for CML; CM in the case of patients undergoing treatment for multiple myeloma). * Long-term efficacy (progression-free survival, overall survival). * Effect of FMD on HOMA index, PCR, circulating levels of IGF-1 and urinary levels of ketone bodies. * Effect of FMD on lymphocyte subsets, NK cells and antigen-presenting cells with a role documented in antitumor immunity. It is foreseen that 60 patients will be enrolled. #Intervention - OTHER : Prolon - Prolon by L-Nutra is a medically-designed dietary kit providing the food to eat for five days. Day 1 of Prolon provides \~4600 kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide \~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day. - Other Names : - fasting-mimicking diet

#Eligibility Criteria: Inclusion Criteria: * Written informed consent * Age > 18 years * Patients with solid or hematologic tumors undergoing active treatment, including patients who are preparing to start a new treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biologics (including trastuzumab) , pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (eg Opdivo, Keytruda), ie patients in whom treatment is already underway; * ECOG performance status 0 <= age <= 1 * Adequate organ function * BMI >21 kg/m2 (with possibility to also enroll patients with 19<BMI<21 based on the judgement of the treating physician) * Low nutritional risk according to nutritional risk screening (NRS) Exclusion criteria: * Diabetes mellitus; * Previous therapy with IGF-1 inhibitors; * Food allergies to the components of the FMD; * BMI <19 kg/m2; * bio-impedance phase angle <5.0°; * medium/high nutritional risk according to NRS; * Any metabolic disorder that can affect gluconeogenesis or ability to adapt to fasting periods; * Patients who live alone or are not adequately supported by the family context; * Treatment in progress with other experimental therapies. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03595540

{ "NCT_ID" : "NCT02289014", "Brief_Title" : "Web-based Stress Management for Newly Diagnosed Cancer Patients (STREAM-1)", "Official_title" : "Web-based Stress Management for Newly Diagnosed Cancer Patients (STREAM-1): A Randomized, Wait-list Controlled Intervention Study", "Conditions" : ["Psychological Distress", "Cancer"], "Interventions" : ["Other: online stress Management program"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Many cancer patients experience their illness as substantial psychological burden. About half of the cancer patients suffer from severe stress symptoms and around one third of the patients fulfill the criteria for a clinically relevant psychological disorder (mainly anxiety disorder and/or major depression). Studies show, that a high level of distress in cancer patients is associated with more side effects of and a reduced compliance for oncological treatment. Today, the efficacy of psycho-oncological interventions is well studied and proven. Besides the reduction of levels of anxiety, distress and depression, psycho-oncological support facilitates dealing with physical complaints and increases quality of life. Yet, psycho-oncological support is rarely utilized by male patients and insufficiently accessible for many patients (i.a. lack of supply in the respective area, cost issues). The internet overcomes some of these barriers, as it can be used independently of time and location. Internet-based therapies are therefore a growing field of interest in research and there is evidence for treatment efficacy for several psychological disorders. Moreover effect sizes of traditional face-to-face and interactive web-based interventions are comparable. However, web-based interventions for cancer patients are still scarce. The present research project therefore develops a comprehensive stress management program accessible for a vast number of cancer patients. The study targets primarily to evaluate the feasibility of the program (technical, organizational feasibility, accessibility). In addition, the preliminary efficacy of the program will be analyzed in order to adapt future programs for specific patient groups. Detailed Description The present study is designed as a randomized controlled wait-list intervention study. Within 12 weeks of the start of anti-cancer treatment, patients will be randomly assigned to the web-based stress management intervention or a wait-list control condition. Inclusion criteria: Patients with any kind of newly diagnosed cancer undergoing first Treatment regardless of the Setting. Patients undergoing first treatment for newly diagnosed relapse of cancer, who have received prior curatively-intended Treatment. Inclusion is allowed immediately prior to or within 12 weeks of the start of treatment. If surgery was performed initially and is followed by systemic treatment or radiotherapy, start of systemic treatment or radiotherapy is counted as first treatment. Prior treatment -including chemotherapy- for a different, prior malignant tumor is allowed. Concomitant participation in an experimental therapeutic drug trial is allowed. Age \>18 years. Command of the German language. Internet access and basic computer skills. Life expectancy of \>6 months. Exclusion criteria: Patients undergoing second- or further line treatment. Patients treated with surgery only. Patients participating in a concomitant psychological intervention trial #Intervention - OTHER : online stress Management program - Active treatment group

#Eligibility Criteria: Inclusion Criteria: * Patients with any kind of newly diagnosed cancer undergoing first treatment (including radiotherapy, hormonal treatment, targeted therapies, chemotherapy or combined-modality treatment) regardless of the setting (adjuvant treatment, curative treatment, palliative first-line treatment) * Patients with newly diagnosed relapse of cancer, who had received prior curatively-intended treatment * Inclusion is allowed immediately prior to or within 12 weeks of the start of treatment * Patients must have cytologically or histologically proven diagnosis of malignant disease (either at diagnosis or at relapse) * Prior treatment -including chemotherapy- for a different, prior malignant tumor is allowed * Concomitant participation in an experimental therapeutic drug trial is allowed * Age >18 years * Command of the German language * Internet access and basic computer skills * Life expectancy of >6 months Exclusion Criteria: * Patients undergoing palliative second- or further line chemotherapy treatment * Patients treated with surgery only * Patients participating in a concomitant psychological intervention trial Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02289014

{ "NCT_ID" : "NCT02457793", "Brief_Title" : "A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors", "Official_title" : "A Phase Ib, Open-Label, Dose-Escalation Study Of The Safety, Tolerability, and Pharmacokinetics of Cobimetinib and GDC-0994 In Patients With Locally Advanced or Metastatic Solid Tumors", "Conditions" : ["Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma"], "Interventions" : ["Drug: Cobimetinib", "Drug: GDC-0994"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or metastatic solid tumors for which standard therapies either do not exist or have proven ineffective or intolerable. #Intervention - DRUG : Cobimetinib - Cobimetinib given concurrently or intermittently with GDC-0994 for 21 consecutive days followed by 7 days off. - DRUG : GDC-0994 - GDC-0994 given for 21 consecutive days followed by 7 days off, along with concurrent or intermittent dosing of cobimetinib.

#Eligibility Criteria: Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable * Evaluable disease or disease measurable * Life expectancy > or = 12 weeks * Adequate hematologic and end organ function * For female patients of childbearing potential and male patients with partners of childbearing potential, use of an effective form of contraception with continued use for study duration and up to 3 months or more following discontinuation of treatment drug * Fluorodeoxyglucose positron emission tomography (FDG-PET) avid disease on baseline scan For enrollment in part 2, patients must meet all of the following: * Measurable disease * No more than four prior systemic therapies for locally advanced or metastatic cancer Exclusion Criteria: * History of prior significant toxicity from another MEK inhibitor or ERK inhibitor requiring discontinuation of treatment * Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis * History of glaucoma * Intraocular pressure > 21 mmHg as measured by tonometry * Predisposing factors to retinal vein occlusion (RVO) * History of RVO, neurosensory retinal detachment, or neovascular macular degeneration * Allergy or hypersensitivity to components of the cobimetinib or GDC-0994 formulation * Palliative radiotherapy within 2 weeks prior to first dose of study-drug treatment in Cycle 1 * Experimental therapy within 4 weeks prior to first dose of study-drug treatment in Cycle 1 * Major surgical procedure or significant traumatic injury within 4 weeks prior to the first dose of study-drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment * Anti-cancer therapy within 28 days prior to the first dose of study-drug treatment in Cycle 1 * Current severe, uncontrolled systemic disease * History of clinically significant cardiac dysfunction * History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment * History of myocardial infarction within 6 months prior to the first dose of study-drug treatment in Cycle 1 * History of congenital long QT syndrome or QTc > 470 msec * LVEF * History of malabsorption or other condition that would interfere with enteral absorption * Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus * Any condition requiring warfarin or thrombolytic anticoagulants * Active autoimmune disease * Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment * Pregnancy, lactation, or breastfeeding * Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms * No other history of or ongoing malignancy that would potentially interfere with the interpretation of the Pharmacodynamic (PD) or efficacy assays Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02457793

{ "NCT_ID" : "NCT03411980", "Brief_Title" : "Pharmacokinetics and Safety of Vilaprisan in Renal Impairment", "Official_title" : "An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function", "Conditions" : ["Uterine Fibroids", "Endometriosis"], "Interventions" : ["Drug: Vilaprisan (BAY1002670)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function. Detailed Description This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations. #Intervention - DRUG : Vilaprisan (BAY1002670) - Single oral dose (1 x 2 mg immediate-release, film-coated tablet)

#Eligibility Criteria: Inclusion Criteria: * BMI: 18 to 40 kg/m*2 (inclusive) * Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either: Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis * Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR >=90 mL/min/1.73 m*2 Exclusion Criteria: * Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment. * Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment. * Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin. * Acute renal failure or acute nephritis within the past 2 years. * Pregnancy or lactation. * Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits. * Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT03411980

{ "NCT_ID" : "NCT00426257", "Brief_Title" : "Secondary Debulking Surgery +/- Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer", "Official_title" : "Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy", "Conditions" : ["Ovarian Cancer"], "Interventions" : ["Procedure: Secondary debulking", "Procedure: secondary debulking with intraperitoneal chemotherapy"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer. Detailed Description Rationale: Ovarian cancer is the second most common gynaecologic cancer in the Netherlands preceded by endometrial cancer. It is however the leading cause of death among women with gynaecologic malignancies with an annual mortality rate of 9 per 100.000. The majority of the patients are diagnosed with a high stage ovarian carcinoma due to the fact that symptoms occur at a late stage of the disease and screening methods for ovarian cancer are suboptimal. Optimal treatment consists of a combination of chemotherapy and debulking surgery. Despite the appearance of localized disease and the absence of obvious residual tumour following primary treatment, the majority of patients (80%) will have persistent disease or will develop recurrent disease. Additional strategies are warranted to reduce the recurrence rate and increase disease free survival and overall survival in this group of patients. The concept of administering intraperitoneal chemotherapy is based on the ideas on peritoneal dialysis. Intraperitoneal drug therapy is designed to maximize drug delivery to the tumour with generally acceptable systemic side effects associated with IV administration of the drug. This strategy is especially attractive for treatment of ovarian carcinoma, which remains largely restricted to the abdominal cavity for most of its natural history. So far 3 randomised controlled trials have shown an overall and progression-free survival benefit when cisplatin is administered postoperatively by the IP route in patients with stage III, optimally resected disease. These studies however found that the majority of patients did not complete all planned 6 cycles due to catheter related problems. An alternative way of administering chemotherapy intra abdominally whilst bypassing the use of a catheter intra- abdominally is provided by perfusion of the abdomen during surgery under hyperthermic conditions. This study compares the interval debulking plus or minus the perfusion of the abdomen with chemotherapy under hyperthermic conditions during surgery (OVHIPEC). Objective: The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms. Secondary objectives of this study involve toxicity and morbidity, quality of life, tumour response following treatment and overall survival of the study arm compared to the standard arm. Study design: Phase III randomised trial Study population: Patients diagnosed with stage III ovarian carcinoma, peritoneal cell carcinoma or tuba carcinoma who are eligible for interval debulking surgery either following primary chemotherapy or following incomplete primary debulking and chemotherapy. Age between 18 - 76 yr old. Intervention: One group undergoes interval debulking with hyperthermic perfusion of the abdominal cavity with cisplatin 100 mg/m2 at the end of surgery. The other group is treated by interval debulking only. Main study parameters/endpoints: Recurrence free survival Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants of the study will be asked to fill in quality of life questionnaires (12 times in 2 year). Blood samples will be taken following written informed consent before treatment, during surgery and during follow-up visits for marker studies and proteomics studies (10 times during 2 year). For patients participating in the pharmacokinetic studies (20) 2 tissue samples will be taken from the abdominal cavity during surgery and blood samples will be taken 6 times during and after surgery. During follow-up 3 monthly visits will be scheduled in the first 2 years and 6-monthly visits during year 3-5. During these follow-up visits routine physical exam including pelvic exam and vaginal ultrasound (optional) is performed. CT-scans will be performed in the first 2 years before randomisation and 4 times at follow-up. Risks of participating in this trial are related to the abdominal perfusion of cisplatin. This can cause systemic effects such as: nephrotoxicity, bone marrow toxicity, neurotoxicity, and longer hospital stay. It can also increase the chance on bowel perforation of a bowel anastomoses resulting in a longer hospital stay and possibly surgical intervention. To prevent systemic side effects of intra-abdominally administered cisplatin, sodium thiosulphate is administered intravenously during surgery. #Intervention - PROCEDURE : Secondary debulking - Secondary debulking - PROCEDURE : secondary debulking with intraperitoneal chemotherapy - secondary debulking with intraperitoneal chemotherapy

#Eligibility Criteria: Inclusion Criteria: * Age between 18 and 76 years * Histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO stage III, including serous papillary adenocarcinoma, mucinous adenocarcinoma and endometrioid adenocarcinoma. * In case of pleural effusion cytology should be negative for tumour cells * In case diagnosis is made based on cytology only (i.e. patients treated by primary chemotherapy) additional criteria apply: * Normal mammogram (< 6 weeks before first registration) and * Presence of pelvic mass and * CA 125 > 200 kU/l and * Serum CA125/CEA ratio > 25. If the serum CA125/CEA ratio is < 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for the presence of a primary tumour of the digeste tract (< 6 weeks before registration) and * Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy) * Patients eligible for interval debulking for the following 2 reasons: * Primary debulking surgery not feasible due to tumour extension or general condition (patients treated by primary chemotherapy) or * Incomplete primary debulking with residual disease > 1 cm * In case of primary chemotherapy: * Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol * Following 2 cycles of chemotherapy at least a 30% decrease in the sum of largest diameter (LD) of target lesions taking as reference the baseline sum LD (RECIST criteria, see appendix 1) * In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy: * Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol * General criteria: * Fit for major surgery, ASA 1 or ASA 2 * WHO performance status 0 <= age <= 2 * Written informed consent * Laboratory values: serum creatinine < 140 µmol/L; creatinine clearance > 60 ml/min (Cockroft formula); white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l * For quality of life studies: * Baseline questionnaires should be filled in before randomization Exclusion Criteria: * History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 76 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00426257

{ "NCT_ID" : "NCT00156052", "Brief_Title" : "Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer", "Official_title" : "A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Radiation: Hypofractionated whole breast radiation schedule", "Radiation: Conventional whole breast radiation schedule"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy. The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness. #Intervention - RADIATION : Conventional whole breast radiation schedule - RADIATION : Hypofractionated whole breast radiation schedule

#Eligibility Criteria: Inclusion Criteria: * The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease. * Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue. * Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease. Exclusion Criteria: * Tumour greater than 5 cm in greatest diameter on pathological examination. * The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins. * Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer. * Bilateral malignancy of the breast (synchronous or metachronous). * More than one primary invasive tumour in the same breast. * Previous surgery for breast cancer. * Pathological status of axilla is unknown. * Status for adjuvant systemic therapy not determined. * For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast. * For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy. * Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment. * Currently pregnant or lactating. * Breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm). * Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \\fIin situ\\fR of the cervix which have been effectively treated. * Geographic inaccessibility for follow-up. * Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol. Sex : FEMALE Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00156052

{ "NCT_ID" : "NCT00482261", "Brief_Title" : "A Study of Low Dose Lenalidomide and Dexamethasone in Relapsed/Refractory Myeloma in Patients at High Risk for Myelosuppression", "Official_title" : "Phase II Trial of Low Dose Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (Rev-Lite) in Patients at High Risk for Myelosuppression", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Drug: dexamethasone", "Drug: Lenalidomide", "Drug: aspirin"], "Location_Countries" : ["Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to see whether combination of low dose lenalidomide(10mg)+ dexamethasone is equally effective in treating relapsed/refractory myeloma in the group of elderly patients and other patients at risk of myelosuppression, whilst producing less side effects, especially myelosuppression compared to the higher dose of lenalidomide of 25mg used in the MM-009 and MM-010 trials. Detailed Description Lenalidomide has proven efficacy in myeloma. In the Phase I studies with lenalidomide monotherapy, responses were observed at doses of 5mg, 10mg and 25mg. The dose limiting toxicity of lenalidomide monotherapy was myelosuppression· In the International MM-010 and MM-009 studies, lenalidomide was administered at 25mg d1-d21 (with pulse dexamethasone) of a 28 day cycle. Although the overall response rate and time to progression were impressive, a significant toxicity was myelosuppression. The average age in these 2 studies was approximately 63 years, some 7 years lower than the median age for myeloma. The median number of prior therapies was 2. Thus, if lenalidomide therapy is to be optimally applied in an older and/or more heavily pre-treated population, a simpler, less toxic regimen would be valuable. Low dose (15mg) lenalidomide (Rev-Lite) with dexamethasone may achieve this goal· Based on analysis of the MM009 and MM010 data the patients at highest risk for myelosuppression and subsequent dose reduction were those over the age of 60 years (approx 30% risk which increased to approx 50% by 70 years).It is hypothesized that patients with lower base-line platelets may also be at higher risk of lenalidomide-induced myelosuppression. Little is known about lenalidomide tolerance in patients with impaired renal function, consequently patients with relatively poorer renal function will also be enrolled into this study. #Intervention - DRUG : Lenalidomide - 15mg daily, days 1-21 of a 28 day cycle for 4 cycles. Patients who get stable disease or better will then receive 15mg on days 1-21 from cycle 5 onwards - DRUG : dexamethasone - 20mg day 1-4, 9-12, 17-20 for 4 cycles. Patients who get stable disease or better will then get dexamethasone 20mg on days 1-4 of a 28 day cycle, from cycle 5 onwards - DRUG : aspirin - 100mg/day

#Eligibility Criteria: Inclusion Criteria: * Understand and voluntarily sign consent form. * Must meet one of following age group requirements at the time of signing consent form. 1. age 18 <= age <= 59 years 2. >59 years * Patients 18 <= age <= 59 years are eligible only if: * platelets between 50 <= age <= 74x109/L or * calculated GFR between 20ml/min and 59ml/min * Able to adhere to the study visit schedule and other protocol requirements. * Subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria. * Must have relapsed or refractory disease. * Measurable disease, defined as follows: * For secretory multiple myeloma: measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not necessarily, >5g/L of M-Protein). If the M band is <5g/L, then the serum free light chains(SFLC) must be assessed and if >100mg/L will also be used to measure disease response. Where applicable, urine light-chain excretion of >=200 mg/24 hours will also be used to measure disease response. * For light chain disease (M band in serum <5g/L but measurable FLC in urine): measurable disease is defined by either urine FLC OR the presence of serum FLC (must be >100mg/L). Investigators can use either test (or both) but must use the same method throughout the trial. * For non-secretory multiple myeloma (no M-protein in serum or urine by immunofixation): measurable disease is defined by soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). * Patient has a life-expectancy >=3 months. * All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study. * ECOG performance status of <=2 at study entry * Laboratory test results within these ranges: * Absolute neutrophil count ³ 1.0 x 109/L (can be supported with growth factor) * Total bilirubin <=1.5 mg/dL * AST (SGOT) or ALT (SGPT) <=2 x UL * For females subjects: * Must have two negative pregnancy tests (sensitivity >= 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10 <= age <= 14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. * Females of childbearing potential (FCBP)† must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. * Male Subjects: * Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. * Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure. * Disease free of prior malignancies for >=3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma 'insitu' of the cervix or breast. * Able to take aspirin daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin). Exclusion Criteria: * Dexamethasone resistant myeloma based on last therapy. Patients are defined as being refractory to high-dose dexamethasone if they achieved less than a partial response, or developed progressive disease within 6 months of discontinuing dexamethasone, or dexamethasone was discontinued because of >=Grade 3 dexamethasone-related toxicity. High-dose dexamethasone therapy is defined as >500mg dexamethasone or equivalent over a 10-week period, whether administered alone or as part of the VAD regimen. * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Use of any other experimental drug or therapy within 28 days of baseline. * Known hypersensitivity to thalidomide. * The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * Any prior use of lenalidomide. * Concurrent use of other anti-cancer agents or treatments. * Known positive for HIV or infectious hepatitis, type A, B or C. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00482261

{ "NCT_ID" : "NCT02075112", "Brief_Title" : "Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck", "Official_title" : "A Pilot Study of Soy Isoflavone, Genistein, in Combination With Radiation Therapy and Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck", "Conditions" : ["Cancer of Head and Neck"], "Interventions" : ["Drug: Soy isoflavone", "Radiation: Radiation", "Drug: Cisplatin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce this symptom and other side effects of chemoradiation. Detailed Description Concurrent chemoradiation is the standard of care for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Improving the outcome for patients with this disease remains a major challenge. #Intervention - DRUG : Soy isoflavone - Patients will receive genistein 150 mg daily for the duration of radiation treatment. If a patient is experiencing significant side effects attributable to genistein, the treating physician has the option to reduce genistein to 150 mg every other day. - Other Names : - Genistein - RADIATION : Radiation - All patients will undergo computed tomography (CT) simulation with intravenous (IV) contrast unless medical contraindications to IV contrast exist. Gross disease will be treated to 70 Gy in 2 Gy/day. - DRUG : Cisplatin - Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment. - Other Names : - Platinol

#Eligibility Criteria: Inclusion Criteria: * Biopsy proven squamous cell carcinoma of the head and neck (SCCHN) * Primary disease site involving the oropharynx * Clinical stage III or IV * Age >= 18 * Karnofsky Performance Status (KPS) >= 70 * Adequate bone marrow, kidney, and hepatic function (no laboratory value > 2 times the normal limit) * Amylase (0 <= age <= 160 U/L) and lipase (0 <= age <= 130 U/L) levels within 1.5 times the range of normal Exclusion Criteria: * Prior history of SCCHN * Prior history of radiation to the head and neck region * KPS < 70 * Soy allergy * Contraindication to cisplatin chemotherapy or plans to alter or reduce cisplatin therapy * Any head and neck cancer of non-squamous histology * Any head and neck subsite other than oropharynx (including unknown primary site) * Patients who are pregnant or lactating * Patients who may benefit from surgical resection Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02075112

{ "NCT_ID" : "NCT00575744", "Brief_Title" : "Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation", "Official_title" : "Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation", "Conditions" : ["Breast Cancer"], "Interventions" : ["Procedure: Sentinel Node Biopsy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes. Detailed Description Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively. #Intervention - PROCEDURE : Sentinel Node Biopsy - Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive. - Other Names : - Axillary Node Dissection, Technitium Sulfur Colloid, Lymphazurin Blue Dye

#Eligibility Criteria: Inclusion Criteria: * Breast cancer requiring lymph node evaluation * Clinically negative lymph nodes in the axilla * Willing participation following an informed consent process Exclusion Criteria: * Patients with clinically positive lymph nodes * Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis) * Previous axillary lymphadenectomy Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00575744

{ "NCT_ID" : "NCT01938443", "Brief_Title" : "A Dose Escalation Study to Assess Safety of GSK2256098 (FAK Inhibitor) in Combination With Trametinib (MEK Inhibitor) in Subjects With Advanced Solid Tumors", "Official_title" : "A Phase 1b, Multi-center, Open-label, Dose Escalation Study of GSK2256098 (FAK Inhibitor) in Combination With Trametinib (MEK Inhibitor) in Subjects With Advanced Solid Tumors", "Conditions" : ["Cancer", "Neoplasms"], "Interventions" : ["Drug: GSK2256098", "Drug: Trametinib"], "Location_Countries" : ["France", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to assess the safety of combination treatment of GSK2256098 and trametinib in mesothelioma subjects and subjects with other selected tumor types. Also, the study will identify a maximum tolerated combination dose of GSK2256098 and trametinib. This study is a Phase I, open-label, dose-escalation study to determine maximal tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and regimens for oral MEK inhibitor trametinib (once daily \[OD\]dosing) and the oral FAK inhibitor GSK2256098 (twice daily \[BID\] dosing). The synergy of the combination was observed over a wide range of concentrations and results in several-fold reduction in compound concentration to achieve equivalent biological responses compared to either single agent. The dose and schedule of dosing may be modified based on emerging safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. The study will be conducted in two parts; Part 1 Dose Escalation to determine the MTD and RP2D and Part 2 Expansion Cohort to further evaluate the safety and tolerability of trametinib and GSK2256098 at the RP2D and determine clinical activity. Additionally, in Part 1 Dose Escalation, additional subjects with malignant pleural mesothelioma (MPM) will be recruited at doses that are considered tolerable in order to assess PD in MPM subjects at each dose (the Pharmacodynamic Cohort). The Expansion Cohort will be limited to subjects with MPM who have progressed or are intolerant to first-line therapy. #Intervention - DRUG : GSK2256098 - GSK2256098 250 mg will be supplied as white to off-white, round, biconvex tablets with no markings. GSK2256098 will be administered 30 minutes after a light meal with approximately 240 milliliter of water. - DRUG : Trametinib - Trametinib 0.5 mg will be supplied as capsules with no identifying markings. Trametinib will be administered orally under fasting conditions two hours after a meal.

#Eligibility Criteria: Inclusion Criteria Part 1 Subject Inclusion Criteria: * Subjects with measurable tumors that may benefit from treatment with GSK2256098 and trametinib. This includes mesothelioma along with tumors with a high likelihood of MAPK pathway activation as reported in the medical literature. Part 2 Subject Inclusion Criteria: * Histologically- or cytologically- confirmed diagnosis of recurrent or progressive, unresectable MPM with measurable lesion. Part 1 and Part 2 Subject Inclusion Criteria: * Written informed consent provided. * Males and females >=18 years (at the time consent is obtained). * Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. * Able to swallow and retain orally administered study treatment. * Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use effective contraception as per study protocol specification. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as as per study protocol specification. * Adequate organ system functions as defined in the protocol Exclusion Criteria * Mesotheliomas originating outside of the pleural cavity (e.g., peritoneal mesothelioma) are excluded in the Pharmacodynamic Cohort in Part 1 and Part 2, but are permitted in Dose Escalation Cohorts in Part 1. * Subjects with leptomeningeal or brain metastases or spinal cord compression. * Use of an investigational anti-cancer drug within 28 days or five half-lives with a minimum duration of 10 days from prior therapy preceding the first dose of GSK2256098/trametinib OR Chemotherapy within the last 3 weeks (6 weeks for prior nitrosourea or mitomycin C) OR any major surgery, radiotherapy, or immunotherapy within the last 4 weeks. NOTE: Limited palliative radiation (i.e., duration typically < 15 days) with last dose >=6 weeks preceding the first dose of combination treatment is acceptable provided subject meets all of the other eligibility criteria and radiotherapy port does not encompass all measurable tumor. In addition, prophylactic radiation therapy to the site of tumor biopsies (as per the standard of care) during the current study to prevent seeding of the needle tract/biopsy is acceptable and does not require dose modification. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2256098 or trametinib. * Previous treatment with GSK2256098 or trametinib, as well as other MEK or FAK inhibitors. * Current use of a prohibited medication or requires any of these medications during treatment. * Current use of warfarin for therapeutic anticoagulation. NOTE: Low molecular weight heparin is permitted. PT/PTT must meet the inclusion criteria. * Presence of an active gastrointestinal disease, or other condition known to interfere significantly with the absorption, distribution, metabolism, or excretion of drugs. * History or evidence of cardiovascular risk including any of the following: Left ventricle ejection fraction (LVEF) < lower limit of normal (LLN) per local institutional practice; A QT interval corrected for heart rate using the Fredericia's formula (QTcF) >=480 msec;History or evidence of current clinically significant uncontrolled arrhythmias; Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible; History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization; History or evidence of current >= Class II congestive heart failure as defined by New York Heart Association; Treatment refractory hypertension defined as a blood pressure of systolic> 140 millimeter of mercury (mmHg) and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy; Patients with intra-cardiac defibrillators or permanent pacemakers; Known cardiac metastases; * Active interstitial lung disease or pneumonitis. * History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): History of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes); Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as: Evidence of new optic disc cupping, Evidence of new visual field defects and Intraocular pressure > 21 mmHg * Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (subjects with laboratory evidence of cleared HBV and HCV infection will be permitted). * History of another malignancy (excludes non-melanoma skin cancer). Exception: Subjects who have been continuously disease-free for 3 years or who have had complete resection of a non-invasive primary cancer within 3 years of enrollment. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above. * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. * Concurrent condition that in the Investigator's opinion would jeopardize compliance with the protocol. * Nursing female. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01938443

{ "NCT_ID" : "NCT01151670", "Brief_Title" : "Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors", "Official_title" : "Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction", "Conditions" : ["Brain Neoplasms, Malignant", "Brain Neoplasms, Benign", "Malignant Meningioma", "Glioblastoma Multiforme", "Anaplastic Astrocytoma"], "Interventions" : ["Drug: Pioglitazone", "Drug: pioglitazone"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction caused by radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with brain tumors. Detailed Description PRIMARY OBJECTIVE: I. To evaluate the tolerability and toxicity associated with two different dose regimens of pioglitazone administered orally as a cytoprotective agent against radiation-induced brain injury. SECONDARY OBJECTIVE: I. To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic patients. OUTLINE: Patients undergo fractionated external beam radiotherapy, 3-D conformal radiotherapy, or intensity-modulated radiotherapy. Patients receive oral pioglitazone hydrochloride once daily before for 1 week prior to brain irradiation, during and and continuing for 6 months after completion of radiation radiotherapy. After completion of study treatment, patients are followed periodically. #Intervention - DRUG : pioglitazone - Pioglitazone 22.5 mg daily before, during and after radiation therapy. - Other Names : - Actos - DRUG : Pioglitazone - Pioglitazone 45 mg by mouth daily before, during and after radiation therapy - Other Names : - Actos

#Eligibility Criteria: Inclusion Criteria: * Patients must have histologically or cytologically confirmed brain tumors of the following types: Group 1: malignant brain tumors (glioblastoma multiforme, anaplastic gliomas, brain metastases, and other malignant brain tumors); or Group 2: low grade brain tumors (low grade gliomas, meningiomas, and other low grade brain tumors) * All stages and grades of brain tumors are eligible * Patients must have an ECOG performance status of 0 <= age <= 2 * Patients must have agreed to be treated with fractionated, external beam radiation treatment (EBRT) with either curative or palliative intent (the length of the radiation course must at least be ten fractions) * Patients must have agreed to have CT and MR imaging for purposes of radiation treatment planning, radiation treatment monitoring, and/or radiation treatment evaluation * Patients must have measurable disease and/or relevant anatomic features using Magnetic Resonance Imaging * Prior therapies (cytotoxic, surgery, and radiation) are acceptable * Use of steroids is acceptable when indicated * Patients must be able to understand and willingly give informed written consent to participate * Women of childbearing potential must not be pregnant or nursing and must use medically appropriate contraception if sexually active * Patients must have a life expectancy of greater than 3 months * Patients must be willing to comply with an oral treatment regimen and be able to swallow oral study tablets Exclusion Criteria: * History of allergic reactions to pioglitazone or any other member of the thiazolidinedione family * Current diagnosis of diabetes as defined by fasting blood sugar > 125, treatment with anti-diabetic medications, or history of diabetes * Patients who take insulin * Patients who have NYHA class III or IV heart failure * Patients who have elevated transaminases (AST or ALT > 2.5 times normal limit) * Patients who have significantly impaired renal function (creatinine >= 1.5) * Patients who are significantly anemic (hematocrit < 33% in men, or < 30% in women) * Patients who have symptomatic edema (>= grade 2) * Patients who are on medications that have been shown to have a drug interaction with pioglitazone: atorvastatin (doses > 80 mg/day), systemic anti-fungals, medications with significant CYP 3A4 inhibiting properties * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac, arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study if their pregnancy precludes radiation treatment because ionizing radiation used in radiation treatment is an agent with known potential for teratogenic or abortifacient effects * Patients with psychiatric or social illnesses that may impair compliance with the trial requirements Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01151670

{ "NCT_ID" : "NCT01666899", "Brief_Title" : "Effect of Radiation on Tissue for Delayed Breast Reconstruction", "Official_title" : "Effect of Radiation on Tissue for Delayed Breast Reconstruction", "Conditions" : ["Breast Cancer"], "Interventions" : ["Procedure: Skin and blood vessel procedures"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to investigate the effects of radiation therapy following mastectomy on skin and blood vessels and to use information gathered to determine an ideal time for breast reconstruction after radiation. Detailed Description In the setting of post-mastectomy radiation therapy delayed autologous reconstruction, favored by many attempts to avoid complications encountered with radiating the immediately reconstructed breast. The timing of delayed reconstruction is however not known. The goal of this proposal is to study the gross, structural and vascular changes in radiated mastectomy skin in addition to possible structural and flow changes of the underlying internal mammary vessels over time. We plan to use these objective findings as a basis for determining an ideal time frame for delayed autologous breast reconstruction. Sequential mastectomy skin specimens will be obtained from 20 patients undergoing post-mastectomy radiation therapy over a 24 month period and these specimens will be evaluated histologically. These same patients will also undergo serial examinations and photographic documentation of gross skin changes. Skin perfusion will be assessed by laser Doppler imaging and internal mammary vessel structure, and flow characteristics will be assessed by color Doppler sonography. Based on these studies, we will elucidate short and long term changes in radiated breast skin, showing inflammatory, structural and perfusion patterns that can be correlated with optimal conditions for reconstruction. This has the potential to dramatically change practice patterns of delayed reconstruction for many reconstructive surgeons and more importantly restore what patients loose with mastectomy in a consistent, timely fashion. There is also potential for improved outcomes of delayed breast reconstruction by decreasing the number of reconstructions performed too soon after completion of radiation. #Intervention - PROCEDURE : Skin and blood vessel procedures - Biopsies, skin blood flow studies and ultrasound studies will be performed as described.

#Eligibility Criteria: Inclusion Criteria: * Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy. * Patients who meet criteria 1, who plan on postmastectomy breast reconstruction Exclusion Criteria: * Male patients * Patients under the age of 18 * Patients of advanced age (greater than 75) * Patients with comorbidities that affect wound healing. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01666899

{ "NCT_ID" : "NCT01213979", "Brief_Title" : "Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)", "Official_title" : "Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)(PK-CIA-04)", "Conditions" : ["Non-hematological Malignancies"], "Interventions" : ["Drug: 1000 mg iron isomaltoside 1000", "Drug: 500 mg iron isomaltoside 1000"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from non-hematological malignancies with Chemotherapy induced anaemia. #Intervention - DRUG : 500 mg iron isomaltoside 1000 - 500 mg iron isomaltoside 1000 given as a bolus injection over 2 minutes - DRUG : 1000 mg iron isomaltoside 1000 - 1000 mg iron isomaltoside 1000 given as a infusion over 15 minutes

#Eligibility Criteria: Inclusion Criteria: * Men and women, aged more than 18 years. * Weight above 50 kg. * Subjects diagnosed with non-hematological malignancies (solid tumors only) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles. * Hb < 12 g/dL. * TfS <50%. * Serum Ferritin <800 ng/ml. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Willingness to participate after informed consent. Exclusion Criteria: * Anaemia caused primarily by other factors than CIA. * IV or oral iron treatment within 4 weeks prior to screening visit. * Erythrypoietin treatment within 4 weeks prior to screening visit. * Blood transfusion within 4 weeks prior to screening visit. * Imminent expectation of blood transfusion on part of treating physician. * Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis). * Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate). * Known hypersensitivity to any excipients in the investigational drug products. * Subjects with a history of multiple allergies. * Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit). * History of Immunocompromise and/or history of Hepatitis B and/or C. * Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)). * Rheumatoid arthritis with symptoms or signs of active joint inflammation. * Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life (5 days) of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches). * Planned elective surgery during the study. * Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening. * Known intolerance to oral iron treatment. * Untreated B12 or folate deficiency. * Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01213979

{ "NCT_ID" : "NCT00321815", "Brief_Title" : "Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer", "Official_title" : "A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen", "Conditions" : ["Carcinoma, Non-Small-Cell Lung"], "Interventions" : ["Drug: PF-3512676 + Erlotinib", "Drug: Erlotinib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen. #Intervention - DRUG : PF-3512676 + Erlotinib - PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity - DRUG : Erlotinib - Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity - Other Names : - Tarceva

#Eligibility Criteria: Inclusion Criteria: * Advanced, EGFR-positive NSCLC * ECOG Performance Status 0, 1 or 2 * Measurable disease Exclusion Criteria: * Known CNS metastasis * Pre-existing autoimmune or antibody mediated disease Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00321815

{ "NCT_ID" : "NCT02129257", "Brief_Title" : "Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer", "Official_title" : "Single-arm Phase II Study of Maintenance Therapy With Aflibercept After First-line Treatment With FOLFIRI Plus Aflibercept in Metastatic Colorectal Cancer Patients", "Conditions" : ["Metastatic Colorectal Cancer"], "Interventions" : ["Drug: Irinotecan", "Drug: Folinic Acid", "Drug: 5-Fluorouracil", "Drug: AFLIBERCEPT"], "Location_Countries" : ["Greece"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The AMALTHEA (Aflibercept MAintenance after first-Line THErapy with FOLFIRI+Aflibercept in metastatic colorectal cancer patients) trial is an investigator-initiated, single arm, open-label, phase II study. Patients with histologically proven metastatic colorectal carcinoma will be treated with a combination of FOLFIRI and aflibercept for 6 months. Both Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type (wt) and mutant (mut) patients wil be enrolled. In the absence of Progressive Disease (PD) after 6 months of the combination of chemotherapy and aflibercept, the patient will be treated with a maintenance therapy with aflibercept alone until PD or unacceptable toxicity, investigator's decision or patient's refusal of further treatment or death, whichever comes first. Detailed Description Statistical hypotheses and sample size calculation: It is estimated that the progression-free survival (PFS) rate at 1year will be improved from 33% (corresponding to a median PFS of 7.5 months \[null hypothesis\]) to 47% (corresponding to a median PFS of 11 months \[alternative hypothesis\]) with the combination of first-line Folinic acid/5-Fluorouracil/Irinotecan (FOLFIRI) plus aflibercept therapy in patients with metastatic colorectal cancer (mCRC). Using the one-stage Fleming's design, in order to reject the null hypothesis in a one-sided test with a type I error of 5% and power 80%, 73 patients will be needed to enter the study. Analysis population: * Intent-to-treat (ITT) population: all patients who will have given their informed consent and who will have been correctly registered to the study * Evaluable population for tumor response: all treated patients, without major protocol deviation, with at least one tumor evaluation while on treatment (except for early disease progression or death) and evaluable for response * Safety population: the subset of the ITT population that took at least one dose of study medication Primary analysis: The primary efficacy parameter will be PFS rate at 1 year and it will be calculated in the ITT population. Analysis of secondary endpoints: Response to treatment will be described in a frequency table along with the corresponding percentages and 95% exact confidence intervals. Kaplan-Meier method will be used to estimate median PFS and overall survival (OS) values and 95% confidence intervals. All of these analyses will be performed in the ITT population. Analysis for objective response rate (ORR) will additionally be presented in the evaluable population for tumor response. Adverse Events (AEs) of the safety population for the FOLFIRI-aflibercept treatment part and the maintenance therapy will be presented in frequency tables according to grade, along with the corresponding percentages (N, %). Exploratory endpoints: Univariate and multivariate Cox regression analyses will also be performed to explore prognostic factors among basic clinicopathological characteristics and evaluated biomarkers, with respect to PFS and OS. Time-to-event distributions for the expression of examined markers will be estimated by Kaplan-Meier method and compared using log-rank test. Formalin-fixed embedded tumor tissue blocks will be collected from the primaries or metastases for the immunohistochemical and messenger ribonucleic acid (mRNA) study of key angiogenic effectors and regulators, such as: vascular endothelial growth factor A (VEGF A), vascular endothelial growth factor A-121 (VEGFA-121), vascular endothelial growth factor A121b (VEGFA121b), short and long VEGFA isoforms, metalloproteinase inhibitor 3 (TIMP3), vascular endothelial growth factor B (VEGF-B), placental growth factor (PlGF), vascular endothelial growth factor-C (AVEGF-C), Semaphorins, hypoxia-inducible factor 1 (HIF1), vascular endothelial growth factor receptor 1 (VEGFR1), vascular endothelial growth factor receptor 2 (VEGFR2), neuropilin 1 (NRP1), neuropilin 2 (NRP2), thrombospondin 1 (TSP1), thrombospondin 2 (TSP2), angiopoietin-1 (Ang1), Angiopoietin-2 (Ang2), Tie2, interleukin 8 (IL8), CXC chemokine receptor 1 (CXCR1), CXC chemokine receptor 2 (CXCR2) Pharmacokinetic(PK)/Pharmacodynamic analyses (PD) PK/PD assessments (plasma analytes, plasma free and VEGF-bound aflibercept) will be performed in all registered and treated patients at specified timepoints during both FOLFIRI-aflibercept induction and aflibercept maintenance therapy, to assess the free/bound aflibercept ratio over cycles and the potential correlation with clinical endpoints (safety and efficacy). #Intervention - DRUG : AFLIBERCEPT - Other Names : - Zaltrap, AVE005 - DRUG : Irinotecan - Other Names : - Campto - DRUG : 5-Fluorouracil - DRUG : Folinic Acid

#Eligibility Criteria: Inclusion Criteria * Histologically proven adenocarcinoma of the colon and/or rectum * Metastatic disease confirmed clinically/radiologically * Signed written informed consent * No prior therapy for metastatic disease * Duly documented inoperable metastatic disease, ie not suitable for complete curative surgical resection * At least one measurable or evaluable lesion as assessed by Computed Tomography (CT) scan or MRI (Magnetic Resonance Imaging) according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 * Age >=18 years * Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 <= age <= 2 * Adequate hematological status: * neutrophils (ANC) >=1.5x109/L * platelets >=100x109/L * haemoglobin >=9g/dL * Adequate renal function: serum creatinine level <1.5 mg/dl and Glomerular Filtration Rate>50 ml/min by Cockroft/Gault formula * Adequate liver function: * serum bilirubin <=1.5 x upper normal limit (ULN) * alkaline phosphatase * aspartate aminotransferase (AST) * alanine aminotransferase (ALT) < 5 x ULN * Proteinuria <2+ (dipstick urinalysis) or <=1g/24hour * Regular follow-up feasible * Baseline evaluations performed before registration: clinical and blood evaluations no more than 2 weeks (14 days) prior to registration, tumor assessment (chest X-ray, CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to registration * First course of treatment planned less than 1 week (7 days) after registration * For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior of starting study treatment * Female patients must commit to using reliable and appropriate methods of contraception until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial. Exclusion Criteria * Exclusive presence of bone metastasis only * Uncontrolled hypercalcemia * Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg despite medical therapy), or history of hypertensive crisis, or hypertensive encephalopathy * Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy) * Treatment with any other investigational medicinal product within 28 days prior to study entry * Other serious and uncontrolled non-malignant chronic disease * History or presence of Central Nervous System (CNS) metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizures not controlled with standard medical therapy) * Gilbert's syndrome * Intolerance to atropine sulfate or loperamide * Known dihydropyrimidine dehydrogenase deficiency * Treatment with Cytochrome P450 3A4 (CYP3A4) inducers unless discontinued > 7 days prior to randomization * Any of the following in 3 months prior to inclusion: grade 3 <= age <= 4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis * Other concomitant or previous malignancy, except: * adequately treated in-situ carcinoma of the uterine cervix * basal or squamous cell carcinoma of the skin * cancer in complete remission for >5 years * Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days * Pregnant or breastfeeding women * Patients with known allergy to any excipients to study drugs * History of myocardial infarction and/or stroke or other arterial thrombotic events or pulmonary embolism or unstable angina pectoris within 6 months prior to registration * Poorly controlled cardiac arrhythmias * Bowel obstruction * History of severe tumour bleeding or bleeding disorders * Poorly controlled anti-coagulation therapy (INR>3.0 on coumadin or heparin compounds) * Palliative radiation therapy within 4 weeks prior to registration Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02129257

{ "NCT_ID" : "NCT01084746", "Brief_Title" : "Tailored Interactive Intervention to Increase CRCS", "Official_title" : "Tailored Interactive Intervention to Increase CRCS", "Conditions" : ["Colorectal Cancer Screening"], "Interventions" : ["Behavioral: PC-based tailored intervention", "Behavioral: Printed educational materials"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The primary goal of this research project is to conduct a 5-year prospective randomized trial of a theory-based intervention to increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old. Detailed Description Specific Aim 1: Identify behavioral, social, and environmental factors associated with CRCS in male and female patients ages 50 to 64 years old in a primary care practice in Houston, Texas. 1.1. Update literature reviews of CRCS adherence. 1.2. Conduct secondary analysis of relevant data from other projects. 1.3. Conduct focus groups with primary care patients to determine their knowledge, attitudes, and beliefs about CRCS and to gather data to use for development of the educational intervention. Specific Aim 2: Develop a personal computer (PC)-based tailored interactive intervention based on the transtheoretical (stages of change) model to increase CRCS in accordance with American Cancer Society (ACS) CRCS guidelines. Specific Aim 3: Evaluate the effectiveness of the PC-based tailored interactive intervention for increasing CRCS through a randomized controlled trial. Specific Aim 4: Analyze the relationship between a number of predictor variables and CRCS completion in order to develop a more complete conceptual framework for understanding screening adherence. Specific Aim 5: Conduct a cost-effectiveness analysis of the PC-based tailored interactive intervention for increasing CRCS in a primary care setting. #Intervention - BEHAVIORAL : PC-based tailored intervention - Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk. - BEHAVIORAL : Printed educational materials - Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.

#Eligibility Criteria: Inclusion Criteria: * Receive primary care at the KSC Main Campus in Houston, Texas. * Must have been patients at KSC for at least one year prior to enrollment in the study * Be 50 <= age <= 64 of age * Have had CRC or adenomatous polyps * Must agree to schedule a routine physical examination with their primary care provider and to complete a baseline interview Exclusion Criteria: *Have never been screened or be due for CRCS according to the ACS guidelines Sex : ALL Ages : - Minimum Age : 50 Years - Maximum Age : 64 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01084746

{ "NCT_ID" : "NCT05231746", "Brief_Title" : "A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)", "Official_title" : "A Phase 1, Multicenter, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of hSTC810 Monotherapy in Subjects With Advanced Solid Tumors", "Conditions" : ["Advanced Solid Tumor"], "Interventions" : ["Biological: hSTC810"], "Location_Countries" : ["Korea, Republic of", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors. Detailed Description The study consists of a dose-escalation phase that will evaluate 6 dosing schedules of hSTC810. The first cohort will be single participant cohort. Subsequent escalation cohorts will use a standard 3+3 design, with the ability to backfill up to an additional 6 patients in each dose cohort. #Intervention - BIOLOGICAL : hSTC810 - hSTC810 will be administered as an intravenous infusion (IV)

#Eligibility Criteria: Inclusion Criteria: * Male or female aged at 18 >= years * Capable and willing to give signed informed consent * At least one measurable lesion as determined by RECIST Ver.1.1 * ECOG PS score <= 1 * Expected survival >= 12 weeks * For female or male patients of reproductive potential: Agree to use contraception throughout the study and at least 6 months after the last dose. Exclusion Criteria: * Subject who has received anti-cancer treatment within 4 weeks prior to the first dose of study treatment. * Subject who has received radiotherapy or major surgery within 4 weeks prior to screening. * Any toxicity due to prior therapy that has not resolved to <= Grade 1 or returned to baseline by the time of starting study treatment. * Subject with known severe (>=Grade 3) hypersensitivity to any checkpoint inhibitor. * Clinically significant laboratory abnormalities. * Subject with a history of another invasive malignancy within 3 years before the first dose of study drug. * Subject with active central nervous system (CNS) metastases. * Subject who requires high dose of steroids or other immunosuppressive medications. * Subject with a history of autoimmune disease that has required systemic treatment in the past 2 years. * Subject with active infection that requires systemic antimicrobial treatment. * Subject with active HBV or HCV infection. * Subject who has a known history of HIV infection. * Subject with active tuberculosis. * Subject with a documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class IV within 6 months prior to screening. * Subject with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan. * Subject who has received a prior allogeneic stem cell or solid organ transplant. * Subject with a positive coronavirus disease (COVID) test during screening. * Subjects who have received a live attenuated vaccine within 30 days prior to screening. * Subject with another underlying medical condition. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT05231746

{ "NCT_ID" : "NCT01542944", "Brief_Title" : "TevaGastrim for Stem Cell Mobilization Sibling Donors", "Official_title" : "TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)", "Conditions" : ["Acute Myeloid Leukemia", "Myelodysplastic Syndrome"], "Interventions" : ["Drug: TevaGastrim"], "Location_Countries" : ["Israel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation. #Intervention - DRUG : TevaGastrim - TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.

#Eligibility Criteria: Inclusion Criteria: * Age between 18 and 70 years. * Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation * Written informed consent. Exclusion Criteria: * Inability to tolerate PBPC harvest. * Peripheral venous access not possible. * Positive pregnancy test for female donors. * Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR. * Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study. * Treatment with other investigational drugs. * Known sensitivity to CHO derived products. * HIV positive. * History of malignant disease or current malignancy. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT01542944

{ "NCT_ID" : "NCT03255486", "Brief_Title" : "Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)", "Official_title" : "Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy and Establishment of Preclinical Models of Resistance in Locally Advanced Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Biological: Blood sample"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer Detailed Description Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and establishment of preclinical models of resistance in locally advanced breast cancer #Intervention - BIOLOGICAL : Blood sample - Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture. These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).

#Eligibility Criteria: Inclusion Criteria: * proven invasive breast adenocarcinoma (cytology and / or biopsy). * locally advanced stage (tumor size greater than 2 cm). * neoadjuvant chemotherapy indication validated RCP * Patient eligible for neoadjuvant chemotherapy. * Performance Index according to WHO or less 1. * Patient aged 18 years and older. * Being affiliated to a social security scheme or an equivalent scheme of social protection * Obtaining signed informed consent, and that before any specific prequalification testing. Exclusion Criteria: * presence of metastatic disease at diagnosis. * Breast Cancer inflammatory. * rare histologic subtypes (non ductal lobular and not). * Other cancer (except basal cell skin carcinoma and cancer of the cervix in situ adequately treated and curative) treated in the previous 5 years. * Patient pregnant or nursing or of childbearing age without effective contraception. * Breast cancer in men. * legal incapacity or limited legal capacity. medical or psychological conditions allowing the subject to complete the study or to sign the consent (art. L.1121 <= age <= 6, L.1121 <= age <= 7, L.1211 <= age <= 8, L1211 <= age <= 9). Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03255486

{ "NCT_ID" : "NCT01437254", "Brief_Title" : "To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer", "Official_title" : "A Phase I Study of Cyclotron-produced Tc-99m Pertechnetate (CPERT) in Patients With Thyroid Cancer", "Conditions" : ["Thyroid Neoplasms"], "Interventions" : ["Drug: CPERT", "Drug: GPERT"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant validation in the independent expert review conducted by Natural Resources Canada (NRCan) in the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned I-131 Iodide treatment. Detailed Description Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate (GPERT) scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to radioactive iodine therapy. The first 10 subjects will receive a CPERT whole body scan, and and 20 subsequent case-matched controls (2 for each CPERT subject, matched for age and gender) will receive a GPERT whole body scan. CPERT safety will be assessed by pre-injection and post-imaging collection of vital signs and blood samples (haematology and biochemistry). Adverse event collection will be done for both CPERT and GPERT subjects. The whole body biodistribution pattern of CPERT will be qualitatively compared to GPERT by two independent and blinded Nuclear Medicine physicians. #Intervention - DRUG : CPERT - Single 340 MBq CPERT scan in first 10 subjects - DRUG : GPERT - Single 340 MBq GPERT scan in up to 20 case-matched controls

#Eligibility Criteria: Inclusion Criteria: * If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required. * Have confirmed well differentiated thyroid cancer, post-thyroidectomy and pre-RAI * Biochemical parameters as measured are required to be within 5 times the normal limits for age * white blood cell count (WCB) > 3.0/µL * absolute neutrophil count (ANC) > 1.5/µL * Platelets > 75,000/µL * Hemoglobin > 10 g/dL * Able and willing to follow instructions and comply with the protocol * Provide written informed consent prior to participation in the study * Karnofsky Performance Scale score of 50 - 100 Exclusion Criteria: * Nursing or pregnant females * Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the pre-treatment scan * White blood cell count (WCB < 3.0/µL) * absolute neutrophil count (ANC) < 1.5/µL * Platelets < 75,000/µL * Haemoglobin < 10 g/dL * unable and unwilling to follow instructions and comply with the protocol * unable or unwilling to provide written informed consent prior to participation in the study * Karnofsky Performance Scale score <50 Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01437254

{ "NCT_ID" : "NCT02680184", "Brief_Title" : "Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy", "Official_title" : "A Multicenter, Two Part Open-Label, Phase 1B Clinical Study of CMP-001 Administered Either in Combination With Pembrolizumab or as a Monotherapy in Subjects With Advanced Melanoma", "Conditions" : ["Melanoma"], "Interventions" : ["Drug: Pembrolizumab", "Drug: CMP-001"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This study will be conducted in two parts: Part 1 will be conducted using a Dose Escalation and Expansion design. The Part 1 Dose Escalation Phase of this study will identify a safe and tolerable dose to be further evaluated in the Part 1 Dose Expansion phase. Part 2 of the study will be conducted in parallel with the Part 1 Dose Expansion Phase and will evaluate the safety and efficacy of CMP-001 when administered as a monotherapy. A Treatment Extension to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy will be available to those who are currently being treated in either Part 1 or Part 2 of this study at the time of protocol Amendment 9, v10.0. Detailed Description Former Sponsor Checkmate Pharmaceuticals The primary objective of Part 1 of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of CMP-001 when given in combination with pembrolizumab in participants with advanced melanoma. The primary objective of Part 2 of the study is to assess and describe the safety profile of CMP-001 when administered as monotherapy. The primary objective of the Treatment Extension is to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy in the Treatment Extension. Participants enrolled into either Part 1 or Part 2 will continue study treatment as long as they do not experience unacceptable toxicities and when continued treatment, is in the participant's best interest according to the Investigator. Participants may continue therapy beyond progression based upon Investigator judgement of potential benefit. #Intervention - DRUG : CMP-001 - CMP-001 will be administered as per the dose and schedule specified in the respective arms. - Other Names : - vidutolimod - DRUG : Pembrolizumab - Pembrolizumab will be administered as per the schedule specified in the respective arms. - Other Names : - Keytruda

#Eligibility Criteria: Inclusion Criteria: * Histopathologically confirmed diagnosis of metastatic, or unresectable, malignant melanoma. Ocular melanoma participants are not eligible * Participants who are currently receiving treatment with any anti-programmed cell death-1/programmed death-ligand 1 (anti-PD-1/PD-L1) antibody, either alone or in combination and who are progressing. Participants must have received at least 4 doses of anti-PD-1/PD-L1 before enrolling into the CMP-001 <= age <= 001 study; or * Participants who have previously received any anti-PD-1/PD-L1 therapy, alone or in combination and progressed, regardless of the best overall response to prior anti-PD-1/PD-L1 based therapy. Participants must have received at least 4 doses of anti-PD-1/PD-L1 (Inclusion criterion for Part 1 only) * Participants must have at least one tumor lesion with a longest diameter of greater than or equal to (>=)0.5 centimeter (cm) that can be easily palpated or detected by ultrasound to facilitate intratumoral injection of CMP-001 (that is [i.e.], tumor in skin, muscle, subcutaneous tissue or accessible lymph node) * Participants must have measurable disease by RECIST version 1.1. * Capable of understanding and complying with protocol requirements * A life expectancy of greater than 24 weeks at Screening * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Most recent laboratory values (within 3 weeks prior to Week 1 Day 1) before study entry meet the following standards: * Bone marrow function: neutrophil count >=1,000/cubic millimeter (mm^3); platelet count >=75,000/mm^3 and hemoglobin concentration >8.0 grams per deciliter (g/dL). * Liver function: total bilirubin less than or equal to (<=) 1.5 times the upper limit of normal (ULN) ranges of each institution, with the following exception: participants with Gilbert Disease serum bilirubin > 3*ULN; and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 times the ULN range of each institution * Lactate dehydrogenase (LDH) <=2.0 times the ULN range of each institution * Renal function: serum creatinine <=1.5 times the ULN range of each institution * The participant must sign a written informed consent form prior to the initiation of any study procedures. Adult participants unable to provide written informed consent on their own behalf will not be eligible for the study Part 1 Dose Expansion Phase participants must also meet the following inclusion criterion: * At least one additional lesion that is measurable and is not intended for injection (to allow an assessment of systemic antitumor effect). These lesions not intended for injection may be located in any metastatic site. Exclusion Criteria: * Pregnant or breastfeeding * Received investigational therapy (that is, small molecule or biologic) within 30 days prior to the start of CMP-001 dosing on Week 1 Day 1. Received prior therapy with anti- cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody within 30 days (within 45 days for Part 2 participants) prior to the start of CMP-001 dosing on Week 1 Day 1. However, if an investigational therapy has a short half-life, a reduced wash out period may be acceptable with Sponsor approval * Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). If there is no known or documented history of HIV, Hepatitis B or Hepatitis C, the site is not required to do additional testing for these values at Screening * Developed autoimmune disorders of Grade 4 while on prior immunotherapy (Exclusion criterion for Part 1 only). Participants who developed autoimmune disorders of Grade <=3 may enroll if the disorder has resolved to Grade <=1 and the participant has been off systemic steroids at doses > 10 milligrams per day (mg/day) for at least two weeks * Require systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone; replacement doses, topical, ophthalmologic and inhalational steroids are permitted. Participants who have a history of adrenal insufficiency and are receiving greater than 10 mg/day corticosteroid may be eligible but only after Sponsor consultation. Participants who are currently receiving steroids at a dose of <=10 mg/day do not need to discontinue steroids prior to enrollment * Active (i.e., symptomatic or growing) central nervous system (CNS) metastases. However, participants with active CNS metastases are eligible for the trial if * the metastases have been treated by surgery and/or radiotherapy, * the participant is off corticosteroids >10 mg/day and is neurologically stable for at least 2 weeks prior to Screening * brain imaging (by CT, positron emission tomography [PET], MRI, or per site standards) completed within 3 months of screening (required for all participants) * Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the participant unable to cooperate or participate in the trial * Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA) * Requires prohibited treatment (i.e., non-protocol specified anticancer pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor) * Women of child-bearing potential who are unable or unwilling to use an acceptable method of contraception Main Criteria for Inclusion: Treatment Extension (CMP-001 alone or in combination with pembrolizumab) * Actively being treated in either Part 1 or Part 2 of this study. * Subject has signed an additional written ICF for Protocol Amendment 9 (v10.0) prior to receiving the first dose of CMP-001 and/or pembrolizumab in the Treatment Extension. Adult subjects unable to provide written informed consent on their own behalf will not be eligible for the study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02680184

{ "NCT_ID" : "NCT02460237", "Brief_Title" : "HPV Self-Test Intervention in Ohio Appalachia", "Official_title" : "Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia", "Conditions" : ["Cervical Carcinoma", "Human Papillomavirus Infection"], "Interventions" : ["Other: Educational Intervention", "Other: Survey Administration", "Procedure: Disease Screening", "Other: Laboratory Biomarker Analysis", "Other: Informational Intervention"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SCREENING", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test intervention among women from Ohio Appalachia in order to determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy. The intervention group will receive culturally appropriate materials and the control group will receive standard materials with their HPV self-test device. Detailed Description PRIMARY OBJECTIVES: I. To determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy and obtain preliminary efficacy data of culturally appropriate materials on self-test use. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing. ARM II: Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing. Participants are followed up at 4 weeks for return of their HPV self-test device and then for 2 months after notification letters are sent. #Intervention - PROCEDURE : Disease Screening - Complete HPV self-test - Other Names : - Disease Screening Procedure, Screening, Screening Intervention - OTHER : Educational Intervention - Receive culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing - Other Names : - Education for Intervention, Intervention, Educational - OTHER : Informational Intervention - Receive standard instructions and information sheet - OTHER : Laboratory Biomarker Analysis - Correlative studies - OTHER : Survey Administration - Ancillary studies

#Eligibility Criteria: Inclusion Criteria: * Ages 30 <= age <= 65 * No Pap test in the last 3 years * Resident of an Ohio Appalachia county * Not currently pregnant or was not pregnant in the last 3 months * No history of invasive cervical cancer * No history of hysterectomy; women will not be eligible for the pilot randomized controlled trial (RCT) if they participated in the focus groups that helped develop this study (focus groups were institutional review board [IRB] approved as Protocol 2014C0086) or the preliminary device test; we will also require women to read and understand English and have the ability to provide informed consent, which will be inferred upon completion and return of the study eligibility, consent, and Health Insurance Portability and Accountability Act (HIPAA) forms Sex : FEMALE Ages : - Minimum Age : 30 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02460237

{ "NCT_ID" : "NCT02733068", "Brief_Title" : "A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.", "Official_title" : "A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of HPV-16/18 Vaccine in Healthy Females Aged 18-30 Years", "Conditions" : ["Human Papilloma Virus Infection Type 16", "Human Papilloma Virus Infection Type 18", "Cervical Intraepithelial Neoplasia"], "Interventions" : ["Biological: HPV-16/18 vaccine", "Biological: HPV-16/18 placebo"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years. Detailed Description This is a multi-centre, randomized, double blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent. This study planned to enrol 12000 healthy female aged 18-30 in 10 study sites. Each participants will received a three-dose schedule of vaccine or placebo randomly but with the proportion controlled as 1:1 for vaccine group and placebo group. After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. Blood samples will be collected before the first inoculation, and one month after the final injection, blood samples will also be collected in a group of participants containing 800 people to detect antibody titer. Follow-up visit will be conducted 14 times: month 0, month 0 + 8 days, month 2, month 2 + 8 days, month 6, month 6 + 8 days, month 7, month 12, month 18, month 24, month 30, month 36, month 48, month 60. When cervical intraepithelial neoplasia grade 2+ (CIN2+) is indicated, the participant will receive standard treatment and drop out from the study. #Intervention - BIOLOGICAL : HPV-16/18 vaccine - 0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months). - BIOLOGICAL : HPV-16/18 placebo - 0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).

#Eligibility Criteria: Inclusion Criteria: * 18 <= age <= 30 healthy female * enable to provide an legal identification * have the ability to understand and sign the Informed Consent Form * confirmed by the investigator that the participant has the ability to comply with the protocol requirements * agreed to use effective contraceptive method in 7 months or has no plan of pregnancy * can avoid vaginal sex within two days (48 hours) before every interview; don't employ a vaginal douche or any other intervention which can influence the gynecological examination and sample collection Exclusion Criteria: * has received HPV vaccine previously; have received other research or unregistered product (drug or vaccine) within 30 days before the first injection * within three months before the first injection, has had received a whole-blood, plasma or immunoglobulin treatment, or planed to receive such treatments during the research period; within 28 days before the research, has had received attenuated live vaccine; or within 14 days has had received inactivated vaccine * has a history of allergic reaction which requires medical intervention; has allergic reaction for vaccine or vaccine-containing elements; has serious adverse effect history for vaccine * has a history of epilepsy, convulsion or has a family history of mental diseases * has immunodeficiency diseases including: AIDS, HIV infection, lymphoma, leukemia, Systemic Lupus Erythematosus, rheumatoid arthritis, Juvenile Rheumatoid Arthritis, inflammatory bowel disease * used immunosuppressor for treatment or corticosteroid drugs for systemic medication in 6 months * asplenia, functional asplenia, or splenectomize * liver and kidney diseases, serious cardiovascular diseases, diabetes, history of malignant tumor * coagulation disorders * in menstrual period or acute diseases * pregnant, or less than 8 weeks after delivery * has a history of sexual transmitted disease * had total hysterectomy or pelvic radiotherapy * has cervical abnormalities * abnormal screening results for cervical cancer or had CIN in two years * according to the judgement of investigator, participant has conditions that were not suitable for this trial * planning to move out of the clinical trial site during the research period * never has vaginal sexual activity Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02733068

{ "NCT_ID" : "NCT00042939", "Brief_Title" : "Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer", "Official_title" : "Phase II Trial of Irinotecan/Docetaxel for Advanced Pancreatic Cancer, With Randomization Between Irinotecan/Docetaxel and Irinotecan/Docetaxel Plus C225 a Monoclonal Antibody to the Epidermal Growth Factor Receptor (EGF-r)", "Conditions" : ["Pancreatic Cancer"], "Interventions" : ["Biological: cetuximab", "Drug: irinotecan hydrochloride", "Drug: docetaxel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells. PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer . Detailed Description OBJECTIVES: * Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms of objective response rate, in patients with metastatic adenocarcinoma of the pancreas. * Determine the time to progression and overall survival of patients treated with these regimens. * Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm A: Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1, 8, 15, and 22. * Arm B: Patients receive docetaxel and irinotecan as in arm A. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then periodically thereafter. PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) #Intervention - BIOLOGICAL : cetuximab - Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks. - Other Names : - Erbitux, C225 - DRUG : docetaxel - Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution. - Other Names : - Taxotere - DRUG : irinotecan hydrochloride - After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. - Other Names : - Camptosar

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed metastatic adenocarcinoma of the pancreas * Sufficient tumor tissue from fine needle aspiration, core biopsy, or open biopsy available for epidermal growth factor receptor testing * At least 1 unidimensionally measurable primary or metastatic lesionge * Age of 18 and over * ECOG performance status 0 <= age <= 1 * Negative pregnancy test * Fertile patients must use effective contraception * Creatinine clearance > 60 mL/min * LVEF normal * Absolute neutrophil count > 1,500/mm^3 * Platelet count > 100,000/mm^3 * Bilirubin <= upper limit of normal (ULN)* * SGOT or SGPT and alkaline phosphatase must meet the criteria for 1 of the following*: * SGOT or SGPT <= 2.5 times ULN AND alkaline phosphatase <= ULN * SGOT or SGPT <= 1.5 times ULN AND alkaline phosphatase > ULN but <= 2.5 times ULN * SGOT or SGPT <= ULN AND alkaline phosphatase > 2.5 but <= 4 times ULN NOTE: *Percutaneous stenting or endoscopic retrograde cholangiopancreatography may be used to normalize liver function tests Exclusion Criteria: * History of uncontrolled arrhythmias * History of congestive heart failure * History of uncontrolled angina pectoris * Prior chemotherapy * Pre-existing neuropathy >= grade 2 * Prior hypersensitivity to polysorbate 80 * Pregnant or nursing Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00042939

{ "NCT_ID" : "NCT00733824", "Brief_Title" : "Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma", "Official_title" : "A Phase I/II Study of Intravenous AMD3100 Added to a Mobilization Regimen of G-CSF to Increase the Number of Autologous Peripheral Blood Stem Cells Collected From Patients With Lymphoma", "Conditions" : ["Lymphoma, Non-Hodgkin", "Hodgkin Disease"], "Interventions" : ["Procedure: Apheresis", "Drug: G-CSF", "Drug: AMD3100"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for lymphoma. The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg. Detailed Description Autologous stem cell transplantation (ASCT) is indicated for patients with non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who have primary progressive disease or who relapse after a chemotherapy-induced complete remission. For these patients, as for other patients undergoing autologous transplantation, the number of CD34+ cells collected is a reliable predictor of neutrophil and platelet (PLT) engraftment after transplantation. AMD3100 (plerixafor) is a promising new mobilizing agent that has demonstrated efficacy in patients with NHL, HL, and multiple myeloma (MM). Although efficacious, the subcutaneous dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis, which can present logistical problems. Intravenous dosing of AMD3100 may result in a faster rise in peripheral CD34+ cell count, so that the drug can be administered the same day as apheresis. Intravenous dosing may also increase the peak CD34+ cell count, improving the number of CD34+ cells collected via apheresis. This Phase I/II study will evaluate the safety and efficacy of intravenous AMD3100 added to the standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for Hodgkin and non-Hodgkin lymphomas. #Intervention - DRUG : AMD3100 - Other Names : - Plerixafor - DRUG : G-CSF - Other Names : - Neupogen, Filgrastim - PROCEDURE : Apheresis - Other Names : - Leukopheresis

#Eligibility Criteria: Inclusion Criteria: * Age 18 <= age <= 75 * Diagnosis of HL or NHL eligible for autologous transplantation * 30 days since last cycle of chemotherapy * ECOG performance status of 0 or 1 * The patient has recovered from all acute toxic effects of prior chemotherapy * WBC >3.0 X 109/l * Absolute PMN count >1.5 X 109/l * PLT count >100 X 109/l * Serum creatinine <= 2.2 mg/dl * AST (SGOT), ALT (SGPT) and total bilirubin < 2X upper limit of normal (ULN) * Left ventricle ejection fraction > 45% (by ECHO or MUGA scan) * FEV1 > 60% of predicted or DLCO > 45% of predicted * Negative for HIV on standard transplant workup * Signed informed consent * Are surgically or biologically sterile or willing to practice acceptable birth control, as follows: * Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence. * Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period Exclusion Criteria: * A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications * Patients who have failed previous collections * A residual acute medical condition resulting from prior chemotherapy * Acute infection * Fever (temp >38C/100.4F) on the day of start of treatment * Positive pregnancy test in female patients * Lactating females * Patients of child bearing potential unwilling to implement adequate birth control * Patients whose actual body weight exceeds 150% of their ideal body weight * History of ventricular arrhythmias * Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization phase * Patients who have deterioration of their clinical status or laboratory parameters between the time of enrollment and transplantation such that they no longer meet entry criteria may be removed from study at the discretion of the treating physician, principal investigator, or sponsor Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00733824

{ "NCT_ID" : "NCT05291494", "Brief_Title" : "A Study on the Effectiveness of WeChat-based Online Education to Reduce Perioperative Anxiety in Breast Cancer Patients", "Official_title" : "A Study on the Effectiveness of WeChat-based Online Education to Reduce Perioperative Anxiety in Breast Cancer Patients: a Prospective Randomized Controlled Study", "Conditions" : ["Breast Cancer Female"], "Interventions" : ["Behavioral: regular preoperative visits and education by ward nurses.", "Behavioral: follow the WeChat public platform to watch the education videos"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Patients who meet the enrollment criteria will be randomly assigned to the WeChat education group and the regular group. In addition to the regular preoperative visits, the WeChat education group will also watch science videos through WeChat before the surgical procedures. The regular group only received regular preoperative visits and education by ward nurses. The main observation indicator is the incidence of preoperative anxiety defined as the scores of State Anxiety Inventory more than 40 points. Detailed Description Patients who meet the inclusion criteria will be randomly assigned to the WeChat online education group or the regular group. Two researchers will conduct preoperative education, preoperative evaluation and postoperative follow-up respectively.The patients in WeChat group will be first assessed by a researcher on admission about anxiety and sleep (base on the State-Trait Anxiety Inventory (STAI) scale and the sleep quality scale (SQS)). Once the assessment completed, the patients are required to follow the WeChat public platform to watch the education videos when they are free. The content of the videos is jointly decided by the breast surgeon, anesthetists, and ward nurse including the overall prognosis, surgical approach, postoperative rehabilitation exercises, preparation for anesthesia, anesthesia approach and possible effects of anesthesia, which covers all aspects of surgery, anesthesia, and perioperative care. The videos are presented in an easy-to-understand pattern to ensure participants of all ages and levels of education comfortably understand the content. Participants can simply click on the video dialogue box in the public platform for playback and watch it unconditionally.Patients in regular group will be also assessed by the same researcher on admission for anxiety and sleep (base on State-Trait Anxiety Inventory (STAI) scale; sleep quality scale (SQS) scale). Upon completion of the assessment, they received oral instruction from the ward nurse covering the same contents as above instead of the education video. #Intervention - BEHAVIORAL : follow the WeChat public platform to watch the education videos - In addition to the regular preoperative visits, the WeChat education group will watch science videos through WeChat before the surgical procedures. - BEHAVIORAL : regular preoperative visits and education by ward nurses. - received oral instruction from the ward nurse covering the same contents as above instead of the education video.

#Eligibility Criteria: Inclusion Criteria: * female patients scheduled for elective breast cancer resection; * aged 18 <= age <= 80,; * American Society of Anesthesiologists (ASA) physical status I-III. Exclusion Criteria: * patients diagnosed with primary breast cancer combined with malignant tumors of other organs (such as lung, kidney, intestine, etc.); * patients with tumor recurrence after reoperation; * patients failing to cooperate with the study for any reason, such as communication disorders. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT05291494

{ "NCT_ID" : "NCT03338959", "Brief_Title" : "Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma", "Official_title" : "A Pilot Study of Pembrolizumab and Neoadjuvant Radiation for Large, High-Risk Soft Tissue Sarcomas", "Conditions" : ["Soft Tissue Sarcoma", "Recurrent Soft Tissue Sarcoma"], "Interventions" : ["Radiation: Radiation Therapy", "Biological: Pembrolizumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I/II trial studies pembrolizumab and radiation therapy in treating patients with intermediate or high-grade soft tissue sarcoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy may work better in treating patients with soft tissue sarcoma. Detailed Description OUTLINE: Patients receive pembrolizumab intravenously (IV) per institutional standard at the Seattle Cancer Care Alliance as an outpatient therapy. Cycles repeat every 3 weeks, up to a maximum of three doses, for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks beginning on Day 1 of Week 2. After completion of study treatment, patients are followed up at 30 days after last dose, 90 days after last dose, 30 days after post-operative visit (wound care follow-up), and then every 12 weeks for up to 1 year, then every 6 months up to 5 years. #Intervention - BIOLOGICAL : Pembrolizumab - Given IV - Other Names : - Keytruda, Lambrolizumab, MK-3475, SCH 900475 - RADIATION : Radiation Therapy - Undergo radiation therapy - Other Names : - Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, NOS, Energy Type

#Eligibility Criteria: Inclusion Criteria: * Be willing and able to provide written informed consent for the trial * Be >=18 years on day of signing informed consent documents * Have measurable disease based on RECIST 1.1 * Have newly diagnosed disease or localized recurrent or oligometastatic lesions that are candidates for radiation * NOTE: Subjects may not have any prior systemic therapy or radiation for this sarcoma. They may have received systemic therapy and/or radiation for a different cancer * NOTE: Oligometastatic disease will be defined as 3 or fewer detectable lesions with plans to radiate all detectable disease with conventionally fractionated radiation prior to resection * Have an intermediate- or high-grade soft tissue sarcoma at the discretion of the reviewing Sarcoma pathologist * The tumor must be at least 3 cm in maximum dimension for intermediate-grade tumors, or 1.5 cm in maximum dimension for high-grade tumors * Have plans to undergo neo-adjuvant radiation and surgery with curative intent. A minimum of 45 Gy is necessary, planned to be administered over a minimum of 25 fractions * Be willing to provide tissue from a newly obtained core incisional or excisional biopsy of a tumor lesion. Archival tissue from a recent clinical or research biopsy (within 90 days prior to Week 1 treatment) may be used in place of a fresh tissue biopsy * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale or > 70% on the Karnofsky scale. Evaluation of performance status is to be performed within 7 days prior to the date of enrollment * Absolute neutrophil count (ANC) >= 1,500/mcL (performed within 28 days of enrollment) * Platelets >= 100,000/mcL (performed within 28 days of enrollment) * Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (performed within 28 days of enrollment) * Criteria must be met without erythropoeiten dependency and without packed red blood cell (pRBC) transfusion within last two weeks * Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (performed within 28 days of enrollment) * Creatinine clearance should be calculated per institutional standard * Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 28 days of enrollment) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN (performed within 28 days of enrollment) * Albumin >= 2.5 mg/dL (performed within 28 days of enrollment) * International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (performed within 28 days of enrollment) * Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (performed within 28 days of enrollment) * Female subjects of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication * All individuals of child-bearing potential must be willing to use an adequate method of contraception, from the first dose of the study medication through 120 days after the last dose of study medication Exclusion Criteria: * Has had prior radiation to affected area * Has one of the following sarcoma subtypes where neoadjuvant chemotherapy is established as practice at our institution: extra-skeletal Ewing's sarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma * NOTE: Pleomorphic rhabdomyosarcoma is allowed. Bone sarcomas including osteosarcoma, Ewing's sarcoma and chondrosarcoma are not allowed. Extra-skeletal Osteosarcoma is considered a soft tissue sarcoma and is allowed. * Has a diagnosis of immunodeficiency or has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) * Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment * Has a known history of active TB (Bacillus tuberculosis) * Hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients * Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers * Has current or a history of any distant metastatic disease (including brain) *NOTE: An isolated or oligo-metastatic regional recurrence may be allowed if all other criteria are met, curative attempt is being pursued * Has known history of (non-infectious) pneumonitis that required steroids, or has current evidence of pneumonitis * Has an active infection requiring systemic therapy * Has known psychiatric or substance abuse disorders that would interfere with adherence to the requirements of the trial * Is pregnant (positive urine pregnancy test within 72 hours prior to enrollment) or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required * Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-CTLA4 or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory 1-cell receptor (eg, CTLA-4, OX 40, CD137) * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of Hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection * Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed. Note: Any licensed coronavirus (COVID-19) vaccine (including for emergency use) is allowed in the study as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (i.e., those not licensed or approved for emergency use) are not allowed. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate, in the opinion of the treating investigator or has not adequately recovered from any major surgery or has ongoing surgical complications * Has had an allogenic tissue/solid organ transplant Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03338959

{ "NCT_ID" : "NCT03009318", "Brief_Title" : "MRS and 11C-methionine PET/CT in the Diagnosis of Glioma", "Official_title" : "Combination of 11C-MET PET and MRS in the Diagnosis of Glioma.", "Conditions" : ["Glioma"], "Interventions" : ["Other: tumors are confirmed by surgery and pathology"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary MET PET and MRS are often performed as imaging tool for the differential diagnosis of gliomas. But both techniques have limitations causing misdiagnosis; thus, the investigators tried to combine these two imaging tools to study whether the combination of MET PET and MRS could raise the diagnosis ability of the radiological diagnosis of gliomas. #Intervention - OTHER : tumors are confirmed by surgery and pathology - Each patient undergoes both MRS and MET PET scan before surgery. The lesion will be considered as a glioma when either MRS or MET PET results indicated the diagnosis. Pathologic diagnosis will be performed to confirm the final diagnosis.

#Eligibility Criteria: Inclusion Criteria: * Patients with non-enhancing supratentorial lesions shown by contrast-enhanced MRI * No surgery, chemotherapy or radiotherapy history * All patients gave written informed consent. Exclusion Criteria: * Patients with infratentorial Neoplasms * Patients with enhancing supratentorial lesions * Recurrent gliomas after surgery * Primary gliomas with history of radiotherapy or chemotherapy * History of malignant tumours at any body site * Inability to give informed consent Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03009318

{ "NCT_ID" : "NCT02206308", "Brief_Title" : "Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.", "Official_title" : "A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.", "Conditions" : ["B-cell Non Hodgkin's Lymphoma"], "Interventions" : ["Biological: Chimeric anti-CD20 monoclonal antibody"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma #Intervention - BIOLOGICAL : Chimeric anti-CD20 monoclonal antibody - Other Names : - SCT400

#Eligibility Criteria: Inclusion Criteria: * aged from 18 <= age <= 75 * having histologically confirmed NHL expressing CD20 antigen * having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 according to WHO scale, and expected survival of at least >= 3 months * signed an informed consent form which was approved by the institutional review board of the respective medical center Exclusion Criteria: * single measurable lesion >=7 cm in diameter * with serious hematologic dysfunction (white blood cell count of <3.0×103/μL; absolute neutrophil count of <1.5×103/ μL; platelet count of < 75×103/μL; hemoglobin level of < 8.0 g/dL; serum immunoglobulin G(IgG) level of <600 mg/dL);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN (>=5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×ULN ) * having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy * had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment * had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry * with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease * having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus * with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days ) * with a history of allergic reaction or protein product allergy including murine proteins * pregnant or lactating or not accepted birth control methods including male patients Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02206308

{ "NCT_ID" : "NCT00364676", "Brief_Title" : "Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease", "Official_title" : "A Phase 1 Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease", "Conditions" : ["Tumors", "Hodgkins Disease", "Non-Hodgkins Lymphoma"], "Interventions" : ["Drug: VLI"], "Location_Countries" : ["Canada", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease. Detailed Description The objectives of this study are: * To assess the safety and tolerability of treatment with VLI. * To determine the maximum tolerated dose (MTD) of VLI. * To characterize the pharmacokinetic (PK) profile of VLI. * To explore preliminary tumor response of VLI. #Intervention - DRUG : VLI - Patients are dosed on Day 1 and Day 8 of a 21-day cycle. - DRUG : VLI - Patients are dosed on Day 1 of a 21-day cycle.

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease * Adequate hematologic, hepatic and renal functions as defined by laboratory tests. * At least 18 years. * Have a life expectancy of at least 12 weeks. * Patients must give written informed consent. * ECOG or Zubrod performance status of 0, 1, or 2. Exclusion Criteria: * Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless patient is stable without requirement of steroids and/or antiseizure medications for at least 3 months) or leptomeningeal tumor involvement. * Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C). * Planned concurrent systemic therapy and/or radiotherapy drug study treatment. * Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study. * Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment. * Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa). * Female patients who are pregnant or lactating. * Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00364676

{ "NCT_ID" : "NCT01297452", "Brief_Title" : "BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors", "Official_title" : "A Phase I Study of BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors", "Conditions" : ["Solid Tumors"], "Interventions" : ["Drug: BKM120 (days 1-21) + paclitaxel (day 1) + carboplatin (day 1)", "Drug: BKM120, Paclitaxel + Carboplatin", "Drug: BKM120 days 1 - 21 plus paclitaxel + carboplatin", "Drug: BKM120 (days 1 - 28, ) plus paclitaxel + carboplatin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to find out the good and bad effects that occur when BKM120 is added to standard chemotherapy with carboplatin and paclitaxel. #Intervention - DRUG : BKM120 days 1 - 21 plus paclitaxel + carboplatin - Patients will receive oral daily BKM120 (days 1 - 21, per dose escalation scheme) plus paclitaxel (175 mg/m2 intravenously, day 1) + carboplatin (AUC 5 intravenously, day 1)on a 21-day cycle. Pegfilgrastim (6 mg/subcutaneously) will be administered on day 2 of each cycle. - DRUG : BKM120 (days 1 - 28, ) plus paclitaxel + carboplatin - Patients will receive oral daily BKM120 (days 1 - 28, per dose escalation scheme) plus paclitaxel (80 mg/m2 intravenously, days 1, 8 and 15) + carboplatin (AUC 5 intravenously, day 1) on a 28-day cycle. - DRUG : BKM120 (days 1-21) + paclitaxel (day 1) + carboplatin (day 1) - BKM120 100 mg (days 1 - 21, per dose escalation scheme) plus paclitaxel (200 mg/m2 intravenously, day 1) + carboplatin (AUC 6 intravenously, day 1) on a 21-day cycle. After enrollment to Groups 1 and 2 has been completed and all patients in Group 1 and 2 have completed the DLT monitoring period, up to 6 additional patients will be enrolled in this EXPANSION COHORT.A - DRUG : BKM120, Paclitaxel + Carboplatin - BKM120 100 mg per oral, days 1 - 21 Paclitaxel (175 mg/m2) intravenously on Day 1 Carboplatin (AUC 5) intravenously on Day 1 EXPANSION COHORT B

#Eligibility Criteria: Inclusion Criteria: * Pathologically confirmed recurrent or metastatic advanced solid tumor, for which there is no curative-intent treatment option. Pathology confirmation must be performed at MSKCC. * Age >= 18 years * ECOG performance status <= 1 * Life expectancy of >= 12 weeks * Adequate bone marrow function as shown by: ANC >= 1.5 x 109/L, Platelets >= 100 x 109/L, Hemoglobin > 9 g/dL * Total calcium (corrected for serum albumin) within normal limits (biphosphonate use for malignant hypercalcemia control is not allowed) * Magnesium >= the lower limit of normal * Adequate liver function. * Serum bilirubin must be within the upper limit of normal. (ULN). AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. * Serum creatinine <= 1.5 x ULN or 24-hour clearance >= 55 mL/min * Fasting plasma glucose (FPG) <=120 mg/dL or <=6.7 mmol/L * HbA1c <= 8% * Negative serum pregnancy test within 14 days before starting study treatment in women with childbearing potential * Ability to swallow oral medication * EXPANSION COHORT B ONLY: Documented genetic alteration (mutation or homozygous deletion) in the PTEN gene, identified by the MSKCC IMPACT assay platform or other CLIA-approved test. Exclusion Criteria: * Patients who have received prior treatment with a P13K inhibitor. * Patients with a known hypersensitivity to BKM120 or to its excipients * Patients with untreated brain metastases are excluded. However, patients with metastatic CNS tumors may participate in this trial, if the patient is > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy * Patients with acute or chronic liver, renal disease or pancreatitis * Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as result of patient's mood assessment questionnaire: * medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) *>= CTCAE grade 3 anxiety * At screening, mood rating scores of >= 10 on PHQ-9 and/or >= 15 on GAD-7, unless overruled by psychiatrist's assessment * Patient selects a response of '1, 2, or 3' for question 9 on PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9) Note: The psychiatric judgment overrules the mood assessment questionnaire result/investigators judgment. If mood rating scores do not meet eligibility criteria and/or the investigator deems that a patient has mood disorder that renders the patient ineligible, that patient may not be registered to the study unless there is a subsequent psychiatric clinic consultation in which the psychiatrist overrules the mood assessment questionnaire result/investigator judgment. * Patients with diarrhea >= CTCAE grade 2 * Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: * ST depression or elevation of >= 1.5 mm in 2 or more leads * Congenital long QT syndrome * History or presence of sustained ventricular arrhythmias or atrial fibrillation * Clinically significant resting bradycardia (< 50 beats per minutes) QTc > 480 msec on screening ECG * Complete left bundle branch block * Right bundle branch block + left anterior hemiblock (bifascicular block) * Unstable angina pectoris <= 6 months prior to starting study drug * Acute myocardial infarction <= 6 months prior to starting study drug * Other clinically significant heart disease such as congestive heart failure requiring treatment (NYHA Class III or IV) or uncontrolled hypertension (please refer to WHO-ISH guidelines) * Patients with uncontrolled diabetes mellitus * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). Patients with unresolved diarrhea will be excluded as previously indicated * Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) <= 2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued * Patients who are currently receiving treatment with QT prolonging medication with a known risk to induce Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug. Please refer to Appendix E for a list of prohibited drugs. * Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. Please refer to Appendix B for a list of prohibited CYP 3A4 inhibitors and inducers. * Patients who have received systemic corticosteroids <= 2 weeks prior to starting study drug. Systemic corticosteroids should not be administered with BKM120 (Usage of steroids as premedications and anti-emetics for paclitaxel and carboplatin, per MSKCC guidelines, is allowed). Steroids given as part of pre-medications for imaging studies are not exclusionary.). * Patients who have received chemotherapy or targeted anticancer therapy <= 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy (except alopecia) * Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) <= 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy (except alopecia) * Patients who have received radiotherapy within <= 4 weeks prior to registration * Patients who have undergone major surgery <= 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * Patients who are currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant. * Patient is currently being treated with olanzapine and/or other drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. * Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Double barrier contraceptives must be used through the trial by both sexes. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. * Known diagnosis of human immunodeficiency virus (HIV) infection * History of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix * Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator * More than 2 prior cytotoxic chemotherapy regimens for recurrent or metastatic disease * Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living). * Patients receiving other investigational therapies * Patients receiving herbal preparations/medications * Patients with any prior history of whole pelvic radiation therapy (WPRT) * EXPANSION COHORT A ONLY: More than one prior cytotoxic chemotherapy regimen (in the setting of recurrent and/or metastatic disease (cytotoxic chemotherapy given as part of neo-adjuvant therapy, adjuvant therapy, or concurrent chemoradiation for curative intent is not included in this exclusion item). This does not apply to Expansion Cohort B. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01297452