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Study Objectives The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel. Conditions: Ovarian Epithelial Cancer Stage III, Stage IV Ovarian Cancer, Stage IV Breast Cancer Intervention / Treatment: DRUG: lapatinib (GW572016), DRUG: Carboplatin, DRUG: Paclitaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients. * Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease. * Ability to swallow and retain oral medications. * Measurable disease Exclusion Criteria: * Treatment with previous weekly carboplatin and paclitaxel. * No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab. * No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.
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Study Objectives This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P) combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and observation time should be about 5 months. During this time the patient should receive 18 CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be randomized into one of two CA4P dose-level groups in order to recommend a preferred dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before and after treatment with CA4P. Conditions: Cancer, Tumor Intervention / Treatment: DRUG: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Advanced malignancy where treatment with carboplatin and paclitaxel is warranted. * Minimum 28-day interval from any surgical, chemotherapy or immunotherapy treatment and a 14-day interval from radiotherapy treatment. * Radiologically measurable disease to meet MRI perfusion criteria. * ECOG performance status less than or equal to 1. * Life expectancy greater than 12 weeks. * Normal ejection fraction. Exclusion Criteria: * Uncontrolled brain metastasis. * Significant cardiac abnormalities. * Prior radiotherapy at the tumor site. * Symptomatic peripheral vascular or cerebrovascular disease. * Uncontrolled hypertension.
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Study Objectives Head and neck cancer squamous cell carcinoma (HNSCC) is a disease with poor survival, especially for African Americans, despite intense treatment including surgery, radiation, and chemotherapy. Delays between surgery and the start of postoperative radiation therapy (PORT) are common, cause excess mortality, and contribute to worse survival in African Americans. Our research team has developed NDURE (Navigation for Disparities and Untimely Radiation thErapy), a novel theory-based patient navigation (PN) intervention to decrease delays and racial disparities starting PORT. In this single-site, open label, single-arm trial, adults with surgically-managed, locally advanced HNSCC, will be enrolled in NDURE to assess the feasibility and acceptability of NDURE as a novel approach to decreasing delays and racial disparities starting PORT after surgery for HNSCC. The investigators will collect information about the accrual rate and NDURE completion rate. Participants will also complete validated questionnaires at baseline and post-intervention to evaluate the feasibility of outcome assessment for NDURE. Post-intervention, patients and providers will undergo interviews to obtain in-depth understanding of the content, format, timing, and delivery of NDURE to optimize the intervention in preparation for a future multi-site study. NDURE could provide the first effective intervention to improve the delivery of timely, equitable PORT after HNSCC surgery, thereby improving survival for patients with HNSCC, decreasing racial disparities in mortality, and developing new standards of clinical care. Conditions: Squamous Cell Carcinoma of Head and Neck Intervention / Treatment: BEHAVIORAL: NDURE Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: Patient and disease characteristics * Age > 18 years at the time of screening * Histologically or pathologically confirmed invasive SCC (or histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity. a. In situations in which the patient fulfills all other inclusion criteria but the biopsy shows SCC in-situ or moderate/severe dysplasia (without definitive evidence of invasive SCC), but the patient is scheduled to undergo curative intent surgery by the treating oncologic surgeon due to clinical suspicion of invasive SCC, the diagnosis of SCC-in situ or moderate/severe dysplasia is sufficient to full the pathologic diagnosis enrollment criterion. * American Joint Committee on Cancer (AJCC) clinical stage grouping III-IV (8th edition) for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx, larynx, paranasal sinuses, and nasal cavity; or AJCC clinical stage grouping III-IV (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary. 1. At screening, AJCC clinical stage grouping should be determined based on a combination of physical exam, diagnostic evaluation with cross sectional imaging of the neck (computerized tomography (CT) and/or magnetic resonance imaging (MRI)) and/or 18-F-fluoro-deoxyglucose positron emission tomography (FDG PET) CT within 30 days 2. In situations in which the patient fulfills all other inclusion criteria but the biopsy shows SCC in-situ or moderate/severe dysplasia (without definitive evidence of invasive SCC), but would otherwise have an appropriate clinical stage grouping as defined in criterion 5, the diagnosis of SCC-in situ or moderate/severe dysplasia is sufficient to full the staging enrollment criterion. * No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings Surgery and adjuvant therapy eligibility * Plan for curative intent surgery at MUSC a. At screening, plan for curative intent surgical resection of the HNSCC at MUSC must be deemed likely by the treating surgeon and/or multidisciplinary tumor board, which must include a fellowship-trained head and neck oncologic surgeon * Plan for PORT (at MUSC or non-MUSC) with or without concurrent chemotherapy following curative intent surgery a. At screening, plan for adjuvant therapy following curative intent surgical resection of the HNSCC at MUSC must be deemed likely by the treating surgeon and/or multidisciplinary tumor board, which must include a fellowship-trained head and neck oncologic surgeon, based on the clinical expectation of at least one of the following adverse features on final pathologic evaluation: extranodal extension (ENE), pathologic T3 or T4 primary, N2 or N3 nodal disease, nodal disease in levels IV or V, perineural invasion (PNI), or lymphovascular invasion (LVI) Exclusion Criteria: * Self-identified Hispanic ethnicity * Presence of cognitive impairment that precludes participation * Failure to undergo curative intent surgery at MUSC * Lack of indication for PORT (with or without concurrent chemotherapy) per National Comprehensive Cancer Network (NCCN) Guidelines based on the presence of at least one of the following adverse features on final pathologic evaluation: ENE, positive margin, pathologic stage T3 or T4 primary, pathologic stage N2 or N3 nodal disease, nodal disease in levels IV or V, perineurial invasion, or lymphovascular invasion * Synchronous untreated malignancy
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Study Objectives The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study. Conditions: Smoking, Nicotine Dependence Intervention / Treatment: BEHAVIORAL: Gain-Framed counseling & Gain-framed materials, BEHAVIORAL: Standard care counseling + standard materials Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: SINGLE
Inclusion Criteria: * Adults (18+ years) * New York State residents * English-speaking * Current smokers who utilize Quitline services seeking quitting assistance for themselves Exclusion Criteria: * Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county
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Study Objectives In this study, the investigators propose to systematically collect and analyse epigastric lymph nodes during complete cytureductive surgery in patients with colorectal carcinomatosis, in order to define their role in the dissemination of colorectal metastases Conditions: Colorectal Carcinomatosis Intervention / Treatment: PROCEDURE: Epigastric lymph node biopsy Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: BASIC_SCIENCE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Patients who will undergo complete cytoreductive surgery for peritoneal metastases from colorectal origin * Patients with complete cytoreductive resection (R1) and a PCI< 20 Exclusion Criteria: * Minor patients * Patients unable to give written informed consent * Previous surgery for colorectal cancer with iliac lymphadenectomy
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Study Objectives The study will investigate if implementation of "see and treat" in the outpatient clinic can optimize the diagnosis, clinical follow-up and treatment of older women with positive cervical screening test. Conditions: Cervical Dysplasia, Cervical Lesion, Cervix Disease Intervention / Treatment: PROCEDURE: Cone biopsy Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Women ≥ 45 years with a positive screening test (abnormal cytology and/or persistence HPV positive) who are referred to the Department of Obstetrics and Gynecology. * Type 2 or 3 transformation zone (a partly or invisible transformation zone). Exclusion Criteria: * Type 1 transformation zone (fully visible) * Current or previous diagnosis of cervical cancer. * Pregnancy or pregnancy wish. * Previously cone biopsy
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Study Objectives The purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is effective in the surgical treatment of simultaneous liver and right lung metastases from colorectal cancer Conditions: Colon Cancer Liver Metastasis, Multiple Pulmonary Nodules Intervention / Treatment: PROCEDURE: Surgery of liver and lung Location: Italy Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Controlled primary disease; * No extrahepatic lesion other than resectable pulmonary metastases at preoperative investigation; * No lymph-node metastases except for those eventually present at the hepatic hilum; * Disregarding number and distribution of liver metastases, technical resectability leaving at least a remnant liver volume of at least 40% of the total liver volume (calculated excluding the tumoral volume) featured by preserved inflow, outflow and biliary drainage. Zero mm free margin was considered acceptable in case of contact or close adjacency (< 5 mm) with 1st or 2nd order portal pedicles and/or major hepatic veins at their caval confluence; * Disregarding number and distribution of lung metastases, all of the detected nodules could be completely removed preserving enough functioning remnant lung based on the results of the preoperative cardio-pulmonary functional tests; * Patients eligible for a J-shaped thoracophrenolaparotomy because carrier of liver metastases located at the caval confluence, or in the paracaval portion of segment 1 or in the upper right segments (4 superior, 7 and 8), or presenting strong-adhesion or infiltration of the diaphragm. Exclusion Criteria: * Patients not suitable for surgery
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Study Objectives This study is aimed at evaluating the effects of intermittent hormonal treatment with complete androgen suppression (Leuprorelin 3.75 milligram \[mg\] sustained release \[SR\] and Flutamide) in patients presenting with stage D2 or Tx Nx M1 ≠ M1a metastatic prostrate cancer, with a prostate specific antigen (PSA) level 5-fold higher than normal (PSA greater than or equal to \[≥\] 20 nanogram per milliliter \[ng/mL\], as quantitated by the Hybritech radioimmunoassay) and with a subsequent decline to normal (PSA less than \[\<\] 4 ng/mL) during the initial 6 months of induction treatment. The results will be compared with those obtained after continuous hormonal therapy with complete androgen suppression. Conditions: Prostatic Neoplasms Intervention / Treatment: DRUG: Leuprorelin, DRUG: Flutamide Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Histologically confirmed metastatic cancer of the prostate (stage D2 or Tx Nx M1 ≠ M1a) with measurable bone or visceral (lung, liver, etc.) metastases (radiographic conformation was necessary in the event of a questionable bone scan detection in conjunction with only slightly elevated PSA levels \[at least 20 ng/mL or less than or equal to 50 ng/mL\]). The prostatic carcinoma could have been diagnosed at an earlier stage and treated without castration. * Metastatic cancer of the prostate requiring first-line therapy. * Pre-assessment PSA 5-fold or higher than the standard level set by the central laboratory, that is, PSA greater than or equal to (≥) 20 ng/mL as quantitated by the Hybritech radioimmunoassay (normal is less than \[<\] 4 ng/mL). * ECOG performance status of no more than 2. * Normal testosterone levels according to the central laboratory standards. * Aspartate transaminase (AST) and alanine transaminase (ALT) < 2.25-fold higher than the standard levels set by the central laboratory (except when liver metastases were present). * Anticipated life expectancy greater than 9 months. * Written informed consent given to participate and collaborate in the study. Inclusion Criteria for Continuous or Intermittent Treatment Phase * Subjects who meet the pre-assessment criteria and who has PSA < 4 ng/mL after 6 months of induction therapy. Exclusion Criteria: * Subject refuse to sign the informed consent form or is likely to be uncooperative or not to comply with the obligations set out in the study protocol. * Subject has received prior hormonal (and neoadjuvant) treatment prompting medical castration (estrogens, hormone-releasing hormone agonists, androgens) or has undergone surgical castration. * Subject has undergone bilateral suprarenalectomy or hypophysectomy. * Subject had another cancer (except basiloma) with the past 5 years. * Subject has serious unstable progressive disease (renal, hepatic, cardiovascular, psychological, etc). * Subject is receiving or has received another experimental treatment within 3 months prior to inclusion. Exclusion Criteria for Continuous or Intermittent Treatment Phase *Subjects who met the pre-assessment criteria and who, after 6 months of induction therapy, had PSA ≥ 4 ng/mL and/or on-treatment signs of disease progression.
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Study Objectives This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Conditions: Fungal Infection, Hematopoietic and Lymphoid Cell Neoplasm Intervention / Treatment: DRUG: Caspofungin Acetate, DRUG: Fluconazole, OTHER: Laboratory Biomarker Analysis, DRUG: Voriconazole Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Age * For centers that will use fluconazole as the antifungal comparator: * Age >= 3 months and < 21 years * For centers that will use voriconazole as the antifungal comparator: * Age >= 2 years and < 21 years * The patient must be undergoing allogeneic HCT from any donor (including matched related) with any stem cell source for any underlying condition * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age * Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/gender as follows: * 0.4 mg/dL (1 month to < 6 months of age) * 0.5 mg/dL (6 months to < 1 year of age) * 0.6 mg/dL (1 to < 2 years of age) * 0.8 mg/dL (2 to < 6 years of age) * 1.0 mg/dL (6 to < 10 years of age) * 1.2 mg/dL (10 to < 13 years of age) * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age) * 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age) * Total bilirubin < 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert's syndrome * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) < 5 x upper limit of normal (ULN) for age * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Within 90 days of enrollment: * Patients with a proven or probable invasive mold infection are not eligible * Patients with an incompletely treated invasive yeast infection are not eligible * Patients with an elevated galactomannan level (>= 0.5 index) within 30 days prior to time of enrollment (if performed) must have a full evaluation for invasive aspergillosis (including a negative chest computed tomography \[CT\] scan) during that time period to be eligible for enrollment * Patients receiving treatment for an IFI are not eligible * Patients with a history of echinocandin or azole hypersensitivity are not eligible * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation * Lactating females are not eligible unless they have agreed not to breastfeed their infants
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Study Objectives Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney. Interruption of renal blood flow via pedicle clamping is often necessary during partial nephrectomy, especially for complex tumors with deep parenchymal invasion. Ischemia-reperfusion injury is a complex process involving several mechanisms including renal vasoconstriction, extensive tubular damage and glomerular injury. The investigators will examine the postoperative renal function of patients who received intraoperative ketorolac and remote ischemic preconditioning during partial nephrectomy. Conditions: Renal Cell Carcinoma Intervention / Treatment: DRUG: Ketorolac tromethamine and remote ischemic preconditioning Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE
Inclusion Criteria: * ASA l and ll * age 20-65 * patients undergoing partial nephrectomy Exclusion Criteria: * preoperative liver or renal dysfunction, * coagulopathy, * chronic alcoholism, * hypersensitivity of NSAID, * history of warfarin, * history of gastric ulcer
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Study Objectives TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC. Conditions: Carcinoma, Renal Cell, Clear-cell Metastatic Renal Cell Carcinoma Intervention / Treatment: BIOLOGICAL: Nivolumab/Ipilimumab Location: Czechia, Spain, Italy, Germany, France, Belgium, Austria, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Signed Written Informed Consent * Subjects must have signed and dated an 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. * Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study. * Target Population * Histological confirmation of RCC with a clear-cell component. * Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC * One (anti-angiogenic or temsirolimus) \[to be eligible for 2nd line tier\] or no prior systemic therapy for RCC \[to be eligible for 1st line tier\] with the following exception: * One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors as well as CTLA-4- or PD-1/PD-L1 immune checkpoint inhibitors, respectively, and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy. * KPS of at least 70% * Measurable disease as per RECIST v1.1 * Tumor tissue (FFPE archival or recent acquisition) must be received by the central vendor (block or unstained slides). (Note: Fine Needle Aspiration \[FNA\] and bone metastases samples are not acceptable for submission). * Patients with intermediate and poor risk categories will be eligible for the study. * To be eligible as intermediate or poor-risk, at least one of the following prognostic factors as per the International Metastatic RCC Database Consortium (IMDC) criteria must be present: * KPS equal to 70% * Less than 1 year from initial diagnosis of RCC (eg, nephrectomy or first diagnostic biopsy) to registration (1st line) or to start of first-line targeted therapy (2nd line), respectively * Hemoglobin less than the lower limit of normal (LLN) * Corrected calcium concentration greater than the upper limit of normal (ULN) * Absolute neutrophil count greater than the ULN * Platelet count greater than the ULN * If none of the above factors are present, subjects are not eligible (favorable-risk). * Age and Reproductive Status * Males and Females, ≥ 18 years of age * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. * Women must not be breastfeeding * Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo five half-lives. The terminal half lives of nivolumab and ipilimumab are up to 25 days and 18 days, respectively. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo five half-lives. The terminal half lives of nivolumab and ipilimumab are up to 25 days and 18 days, respectively. Males who receive nivolumab combined with ipilimumab who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. * Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as described in this section. Exclusion Criteria: * Target Disease Exceptions * Any history of or current CNS metastases. Baseline imaging of the brain by MRI (preferred) or CT scan is required within 28 days prior to registration. * Medical History and Concurrent Diseases * Prior systemic treatment with more than one of the following drugs: mTOR, VEGF or VEGF receptor targeted therapy (including, but not limited to, temsirolimus, everolimus, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab). * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. * Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll. * Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS). * Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection. * Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results. * Major surgery (eg, nephrectomy) less than 28 days prior to the first dose of study drug. * Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug. * Presence of any toxicities attributed to prior anti-cancer therapy, other than alopecia, that have not resolved to Grade 1 (NCI CTCAE v4) or baseline before administration of study drug. * Physical and Laboratory Test Findings * Any of the following laboratory test findings: * WBC < 2,000/mm3 * Neutrophils < 1,500/mm3 * Platelets < 100,000/mm3 * AST or ALT > 3 x ULN (> 5 x ULN if liver metastases are present) * Total Bilirubin > 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) * Serum creatinine > 1.5 x upper limit of normal (ULN) or creatinine clearance < 40 mL/min (measured or calculated by Cockroft-Gault formula) * Allergies and Adverse Drug Reaction * History of severe hypersensitivity reaction to any monoclonal antibody or any constituent of the product. * Other Exclusion Criteria * Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts. * Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
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Study Objectives The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion. Conditions: Hepatocellular Carcinoma Intervention / Treatment: RADIATION: PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Patients> 18 years old * First diagnosis of HCC (no previous treatments received) * Diagnosis of HCC according to The European Association for the Study of the Liver (EASL) 2012 criteria by "non-invasive" imaging on cirrhosis or by histology on cirrhosis or non-cirrhotic liver * BCLC tumor stage A to C (excluding BCLC C with extrahepatic metastases) according to conventional imaging * Will be able to have a PET scanner within 4 weeks after the inclusion visit * Ability to stay 20 minutes longer for PET-CT scans * Need for oral, intra-uterine or mechanical contraception for women of childbearing age * Written consent for participation in the study * Having medical insurance coverage Exclusion Criteria: * Patients classified BCLC stage 0 (single HCC less than 2 cm) * Patients classified as BCLC stage C with extrahepatic metastases * Decreased cirrhosis (Child Pugh C) and / or patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 2 to 4 not candidates for liver transplantation * Uncontrolled diabetes (defined by blood glucose> 1.7 g / L at the time of inclusion) * Hypersensitivity to 18F Fluorocholine or 18F-FDG or any of the excipients * Creatinine clearance <40 mL / min * Contraindication to MRI: pacemaker or implantable cardiac defibrillator not compatible with MRI, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip, intraocular or cerebral metallic foreign bodies, insulin pump * Pregnant or lactating woman * Patient under tutorship or curatorship or safeguard of justice * Known allergy to iodine * Patient deprived of liberty by judicial or administrative decision * Patients with care "State Medical Aid"
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Study Objectives There are different types of hormonal therapy medicines for the treatment of hormone-receptor-positive breast cancer. The purpose of this study is to determine the evolution of two types of hormonal treatment (the drug called "tamoxifen" and a group of medicines called "aromatase inhibitors") during two time periods of 12 months each, in years 2006 and 2008, in the northeast Italian regions. The study will include post-menopausal women who have initiated hormonal therapy medicines in 2006. The study will also verify the rate of implementation of the updated national and international recommendations for the use of adjuvant hormonal therapy in the hormone-receptor-positive breast cancer. Conditions: Post Menopausal, Breast Cancer Location: Italy Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Post-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy between January 2006 and December 2006 or between January 2008 and December 2008 * Documented evidence of the way adjuvant hormonal treatment was initiated. Exclusion Criteria: * Pre- or peri-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy * Patients already enrolled in clinical studies aimed at investigating hormone therapies
13,986
Study Objectives This phase I trial is studying the side effects and best dose of vorinostat in treating patients with metastatic or unresectable solid tumors or lymphoma and liver dysfunction. (closed for accrual as of 04/05/2010) Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vorinostat may have different effects in patients who have changes in their liver function. Conditions: Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Primary Central Nervous System Hodgkin Lymphoma, Primary Central Nervous System Non-Hodgkin Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Adult T-cell Leukemia/Lymphoma, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult T-cell Leukemia/Lymphoma, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, Stage IV Small Lymphocytic Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific, Waldenström Macroglobulinemia Intervention / Treatment: DRUG: vorinostat, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable * Patients with a liver mass, elevated α-fetoprotein level (≥ 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis * Standard curative or palliative measures do not exist or are no longer effective * Patients who have not received any prior therapy for malignancy are also eligible if they are ineligible for standard therapy due to hepatic dysfunction * Patients with abnormal liver function will be eligible * No distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes * Patients with biliary obstruction for which a shunt has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first dose of vorinostat (SAHA) and liver function has stabilized * Two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function * No evidence of biliary sepsis * Patients with gliomas or brain metastases who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for 1 month prior to study enrollment * Patients with known brain metastases should have had brain irradiation (whole brain or gamma knife) more than 4 weeks before starting protocol treatment * Patients with unstable or untreated (non-irradiated) brain metastases should be excluded * ECOG performance status ≤ 2 (Karnofsky ≥ 60%) * Life expectancy > 3 months * Absolute neutrophil count > 1,500/mm\^3 * Platelets ≥ 100,000/mm\^3 * Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * HIV-positive patients without an AIDS-defining diagnosis who are not receiving agents with the potential for pharmacokinetic interactions with vorinostat may be eligible * Able to take oral medications on a continuous basis * No 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 * No active hemolysis * More than 3 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered * Patients who have been treated with agents that persist in the body for longer than 4 to 6 weeks (such as suramin) are ineligible during the elimination period for those agents * More than 14 days since prior major surgery * No prior vorinostat * At least 2 weeks since prior valproic acid or other histone deacetylase inhibitors * More than 4 weeks since other prior investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent therapy with enzyme-inducing anticonvulsants * No concurrent prophylactic granulocyte growth factors during the first cycle of therapy * No other concurrent investigational or commercial agents or therapies
33,159
Study Objectives This is a phase II, Open-Label, Multicenter, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined with Pemetrexed/ Carboplatin in Patients with Brain Metastases of Non-squamous Non-small Cell Lung Cancer. The primary end point is PFS, and secondary endpoint is ORR, OS, DoR and Neurocognitive impairment. during the study, the exploratory objectives including (1) PD-L1 expression, TMB, and other potential predictive biomarkers, correlated with response to treatment (2) Progression-free survival based on intracranial response (iPFS) according to RECIST 1.1 and RANO-BM Conditions: NSCLC Stage IV, Brain Metastases, PD-1 Antibody Intervention / Treatment: DRUG: Tislelizumab, Carboplatin, Pemetrexed Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: Disease-related inclusion criteria: * Histologically confirmed metastatic (Stage IV) not amenable to curative surgery or radiotherapy, non-squamous NSCLC according to American Joint Committee on Cancer (AJCC), 8th Edition. * Radiographically confirmed brain metastases; * No prior systemic treatment for stage IV NSCLC. (Bevacizumab administered for improving radiation-induced encephaledema during irradiating intracranial lesions is not considered as systemic therapy for stage IV NSCLC) * Patients with asymptomatic BM or symptoms can be controlled by low dose corticosteroids (≤ 10 mg/day of prednisone or equivalent) or antiepileptics drugs; * Patients with previous local treatment to BMs should be stable and suitable to receive the systemic treatment; * ECOG PS: 0 \~ 1 * Extracranial measurable target lesions (per RECIST v1.1) * Life expectancy ≥ 3 months Have adequate hematology, clinical chemistry, and organ function as indicated by the following laboratory values (confirmed within 7 days prior to the first dose): * Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L. * International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal \[ULN\]. * Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. * Serum total bilirubin ≤ 1.5 × ULN (total bilirubin must be < 3 × ULN for patients with Gilbert's syndrome). * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or AST and ALT ≤ 5 × ULN for patients with liver metastases. General inclusion criteria: * Able to provide written ICF signed by patient or by his/her legally authorized representative or guardian and can understand and agree to comply with the study protocol and follow-up procedures. * Male or female, aged 18 \~ 75 years on the day of signing ICF. Female patients of childbearing potential and non-sterile male patients must be willing to use a highly effective method of birth control for the duration of the study and for at least 120 days after the last dose of tislelizumab. Exclusion Criteria: Disease-related exclusion criteria: * Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints inhibitors. * Received prior systemic chemotherapy for advanced disease. * Have EGFR mutation or ALK gene translocation. * Patients iwith BMs that have received systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other drugs to relieve or prevent symptoms of BMs. * Patients with intracranial metastases that are locally amenable. * Have received any approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 4 weeks prior to the first dose of study drug. * Have clinically uncontrolled pleural effusion or ascites that requires pleurocentesis or abdominal tapping for drainage within 2 weeks prior to the first dose of study drugs. * Active leptomeningeal metastasis. Exclusion criteria related to study drugs: * History of allergic reactions to any study drugs and their excipients. * Creatinine clearance (Ccr) < 45 mL/min. * Patients with active viral hepatitis that requires treatment as judged by the investigator: a. chronic hepatitis B virus carriers with HBV DNA ≥ 500 IU/mL (2500 copies/mL) (The HBV DNA test will be performed only for patients who have a positive antibody to hepatitis B core antigen (anti-HBc antibody) test); b. patients who have positive hepatitis C virus (HCV) RNA results (The HCV RNA test will be performed only for patients testing positive for HCV antibody). * Active autoimmune diseases that requires systemic treatment and may impact study treatment as assessed by investigator. * Any condition that required extensive chronic treatment with either corticosteroids or any other immunosuppressive medications that may impact study treatment as assessed by investigator. General exclusion criteria: * Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection, etc.; 1) Serious infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; 2) Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc. * Major surgery requiring general anesthesia within 4 weeks before first dose. * Underlying medical conditions or alcohol or drug abuse or dependence that are to be unfavorable for the administration of study drugs or may have affected the interpretation of the results or rendered the patient at high risk from treatment complications. * Concurrent participation in another therapeutic clinical study. Female patients who are pregnant, breastfeeding, or males and females patients planning to have child during the study.
22,002
Study Objectives This randomized phase II trial studies how well temozolomide with or without veliparib works in treating patients with small cell lung cancer that has returned or does not respond to treatment. Temozolomide works by damaging molecules inside the cancer cells, such as deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may stop the growth of tumor cells by blocking proteins that are needed for repairing the damaged DNA and it may also help temozolomide to kill more cancer cells. It is not yet know whether temozolomide is more effective with or without veliparib in treating patients with relapsed or refractory small cell lung cancer. Conditions: Recurrent Small Cell Lung Carcinoma Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, OTHER: Placebo, DRUG: Temozolomide, DRUG: Veliparib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE
Inclusion Criteria: * Patients must have histologically or cytologically confirmed small cell lung cancer; confirmation will be done at Memorial Sloan-Kettering Cancer Center (MSKCC) or locally for participating sites * Patients' disease has relapsed or progressed after one or two prior chemotherapy regimens, one of which must have been an etoposide-platinum doublet; eligible patients will be defined as follows: * "Sensitive" disease: patients who had one previous line of chemotherapy and maintained an appropriate response for > 60 days * "Refractory" disease: those patients with either (a) no response to first-line chemotherapy or progression =< 60 days after completing treatment, or (b) "sensitive" or "refractory" disease in need of third-line therapy (i.e. completed or failed two previous lines of chemotherapy) * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) * Patients with asymptomatic brain metastases that do not require immediate whole brain radiation therapy and are on stable doses of steroids are allowed * Patients must have measurable disease, which is defined as at least one lesion that can be accurately measured in at least one dimension on a computed tomography (CT) scan as per RECIST version 1.1; brain metastases can be considered measurable disease if they meet this criterion * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Hemoglobin >= 8.5 g/dL; the use of transfusion to achieve this criterion should be at the discretion of the investigators * Total bilirubin =< 1.5 mg/dL x institutional upper limit of normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 3.0 x institutional upper limit of normal * Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 50 mL/min/1.73 m\^2 for patients with creatinine levels >= 1.5 x upper limit of institutional normal * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting temozolomide and ABT-888 * Ability to understand and the willingness to sign a written informed consent document * Able to swallow pills * Patients will not be excluded based on the diagnosis of acquired immune deficiency syndrome (AIDS); given the increased risk of infection, these patients should have cluster of differentiation (CD)4 counts above 200 cells/mm\^3; patients with AIDS or human immunodeficiency virus (HIV) not receiving agents with the potential for pharmacokinetic interactions with ABT-888 may be eligible Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study * Patients who have not recovered from adverse events due to agents administered more than 3 weeks earlier; toxicities should have resolved to baseline or to within one grade level of their baseline (not to exceed grade 2) * Patients who have been administered ABT-888, any other PARP-inhibitor, or temozolomide * Patients may not be receiving any other investigational agents * Patients with leptomeningeal involvement * Patients with active seizures or a history of seizures * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or temozolomide * 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; breastfeeding should be discontinued if the mother is treated with ABT-888; these potential risks also apply to temozolomide * Patients with either AIDS or HIV on combination antiretroviral therapy are ineligible * Patients with a synchronous active malignancy requiring treatment
5,258
Study Objectives The purpose of this study is to determine the safety, toxicity and patient tolerance of STA-5312 administered intravenously to patients with relapsed or refractory hematological malignancies and patients with solid tumors. Conditions: Hematological Malignancies, Leukemia, Lymphoma, Metastatic or Unresectable Solid Tumors Intervention / Treatment: DRUG: STA-5312 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Male and female patients 18 years or older with one of the following malignancies: * Histologically or cytologically confirmed hematological malignancy (other than Acute Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically indicated, or, * Histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available. * Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations \[e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)\], and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not currently being considered for re-treatment with conventional regimens * Patients with CLL and other leukemic malignancies will be staged according to the modified Rai staging criteria \[low-risk, intermediate-risk and high risk\]. All patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk patients (Stage I and II) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible * ECOG Performance Status of 0-2 * Life expectancy of greater than 12 weeks. * Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator. * Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and ≥1,500 cells/ul for patients with solid tumors * Platelets greater than 100,000/ul * Hgb greater than 8.5 g/dL * Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal * AST (SGOT) < 2.5 times the upper limit of normal * ALT (SGPT) < 2.5 times the upper limit of normal * Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine clearance greater than 50 mL/min) * Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator. * NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing. * The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Women who are pregnant or lactating. * Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry. * Patients with prior peripheral blood stem cell rescue or bone marrow transplantation. * History of primary brain tumors or active brain metastases. (Patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment) * History of stroke or other significant neurologic limitations within 6 months prior to study enrollment * Use of any investigational agents within 4 weeks of study enrollment. * History of severe allergic reactions to excipients (e.g. Tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312. * 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, as determined by the investigator. * History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection. * Grade 2 or higher sensory or motor neuropathy at screening. * Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.
2,695
Study Objectives The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression. Conditions: Epithelial Ovarian Cancer Intervention / Treatment: BIOLOGICAL: MUC1 Dendritic Cell Vaccine (Cvac) Location: United States, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Female patients ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003 * Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have available Cvac doses) * Were enrolled in CAN-003 and met protocol criteria for progressive disease * Wish to remain in the study and, in the investigator's judgment, the potential benefit of Cvac treatment outweighs the risk * Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion * Able to provide written informed consent * White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL, hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm\^3 Exclusion Criteria: * Pregnant or breastfeeding * Other medical conditions which preclude study participation, in the opinion of the investigator * Receiving treatment with any other investigational product
2,027
Study Objectives The consortium aims to commercialise the MMpredictor as a personalised medicine tool that predicts the most effective treatment strategy for individual Multiple Myeloma (MM) patients. MM is the second most common form of blood cancer contributing to 15% of all blood cancers and \~1,5% and 2% of all cancer deaths annually in the EU and US, respectively. Patients show a large variability in treatment response and side effects due to tumour heterogeneity and the patient's intrinsic characteristics. Therefore, not every treatment will be suitable for each patient, and treatment strategies are often based on trial-and-error. The availability of multiple (\>20) treatment options complicates treatment decision-making even more. With the current development of many more promising treatments, there is an urgent unmet clinical need for a diagnostic assay that supports personalised cancer treatment in order to improve patient health outcomes, prevent side effects and reduce healthcare costs. SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that can subtype MM patients and reliably predict MM patient survival (prognosis). In this project, the test's clinical value will be expanded to include the prediction of treatment effectiveness in individual patients based on Gene Expression Profiling. An addendum for new intended use will be filed to the current in vitro diagnostic (IVD) registration, while renaming the test to MMpredictor. The project will also focus on positioning the test as a cost-effective IVD test for personalised medicine, that will increase health outcome and quality of life of patients and reduce healthcare costs. The consortium consists of a life science SME specialised in molecular diagnostics, clinical centres with world renowned KOLs, a leading health economic institute, and a European MM patient advocacy organisation combining all the required complementary expertise to successfully bring the MMpredictor to market. Conditions: Multiple Myeloma Intervention / Treatment: DIAGNOSTIC_TEST: Gene Expression Profiling Location: Italy Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * The bio-banked MM patient samples and clinical data will be obtained from previous European clinical trials that have been conducted over the past 5 years within the participating clinical centres and other clinical centers. The samples were not collected for the purposes of this project. The subjects from which the data was initially taken cannot be identified from the data/records. However, the patients from the above mentioned trial have explicitly consented for the use of their samples for other (future) clinical research purposes. Exclusion Criteria: *
2,568
Study Objectives The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available. Conditions: Advanced Solid Tumors, Recurrent Solid Tumors Intervention / Treatment: DRUG: ONO-4538 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * The treatment phase has been completed in the ONO-4538-13 study Exclusion Criteria: * The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study. * It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.
38,044
Study Objectives This study is being done in patients that have tumors to find out how well sentinel lymph nodes (SLNs) can be found with a special dye called indocyanine green (ICG). Conditions: Pediatric Patients With Solid Tumors Intervention / Treatment: PROCEDURE: Sentinel Lymph Node Biopsy, DRUG: indocyanine green (ICG) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Patients <30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy * Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. * Patients who are cleared for surgery Exclusion Criteria: * History of reaction to ICG, iodides, or technetium radiocolloid * Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN * Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage * Patients unwilling or unable to sign informed consent * Women who are pregnant or breast-feeding
8,571
Study Objectives Patients at risk for having prostate cancer usually undergo a biopsy of their prostate. This is most often done in the private urology office. Recent studies have suggested that injection of local anesthesia (lidocaine) near the nerves of the prostate will improve pain sensation during the biopsy procedure. Local anesthesia can be given through a separate needle through the rectal probe just prior to biopsy. However, many urologists to date perform their biopsies without anesthesia. Some claim that the needle used for anesthesia causes pain itself. Others claim that the pain is so minimal that the additional use of lidocaine (and extra time) is not necessary. We plan to reexamine the use of lidocaine and perform the first study where each patient will receive lidocaine and placebo on separate sides of their prostate. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Lidocaine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE
Inclusion Criteria: * Patients who are undergoing prostate ultrasound-guided biopsy from the practice of Drs. Diokno and Hollander. * Patients must speak English. * Patients must sign consent form. Exclusion Criteria: * Patients having received prior radiation to the pelvic area. * Patients with any neurologic disorder that may interfere with pain sensation during biopsy. * Allergy to Lidocaine * Patients requiring additional anesthesia (e.g. anxiolytics)
21,243
Study Objectives This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1 prior systemic drug therapy for HCC. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: CF102, DRUG: Placebo Location: United States, Serbia, Bulgaria, Israel, Romania Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE
Inclusion Criteria: * Males and females at least 18 years of age. * Diagnosis of HCC: * For subjects without underlying cirrhosis at the time of diagnosis, diagnosis of HCC documented by cytology and/or histology. * For subjects with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Appendix E). * HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative. * Receipt of 1 previous systemic drug therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3). * Prior systemic treatment was discontinued for at least 2 weeks prior to the Baseline Visit. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B). * Cirrhosis classified as Child-Pugh Class B (Appendix C). * The following laboratory values must be documented within 3 days prior to the first dose of study drug: * Absolute neutrophil count (ANC) ≥ 1.5 × 109/L * Platelet count ≥ 75 × 109/L * Serum creatinine ≤ 2.0 mg/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper limit of normal (ULN) * Total bilirubin ≤ 3.0 mg/dL * Serum albumin ≥ 2.8 g/dL * Prothrombin time (PT) no greater than 6 seconds longer than control. * Life expectancy of ≥ 6 weeks. Exclusion Criteria: * Receipt of no, or of >1, prior systemic drug therapies for HCC. * Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids > 20 mg/day prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial. * Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to ≤ Grade 1, as determined by CTCAE v 4.0. * Locoregional treatment within 4 weeks prior to the Baseline Visit. * Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit. * Use of any investigational agent within 4 weeks prior to the Baseline Visit. * Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy. * Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit. * Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention. * Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness. * Liver transplant. * Active malignancy other than HCC. * Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B). * Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug. * History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females. * Pregnant or lactating female. * Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the subject inappropriate for entry into this trial.
12,185
Study Objectives This phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab with combination chemotherapy may work better in treating participants with classic Hodgkin lymphoma. Conditions: Classic Hodgkin Lymphoma, Lugano Classification Stage III Hodgkin Lymphoma AJCC v8, Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8 Intervention / Treatment: DRUG: Bleomycin, DRUG: Dacarbazine, DRUG: Doxorubicin Hydrochloride, BIOLOGICAL: Rituximab, DRUG: Vinblastine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV * International Prognostic Score of > 2 (patient must have > 2 of the following risk features: Male, >= 45 years of age, stage IV, albumin < 4, white blood cell count \[WBC\] >= 15, lymphocytes < 8% or < 600, hemoglobin \[Hgb\] < 10.5) * Must sign a consent form * Absolute neutrophil count (ANC) >= 1,500/microL * Platelet > 100,000/microL * Left ventricular ejection fraction (LVEF) >= 50% by multigated acquisition (MUGA) scan or echocardiogram * Serum creatinine < 2 mg/dl * Serum bilirubin < 2 mg/dl * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit of normal (ULN) * Bi-dimensionally measurable disease Exclusion Criteria: * Lymphocyte predominant Hodgkin's lymphoma * Known human immunodeficiency virus (HIV) infection * Pregnant women and women of child bearing age who are not practicing adequate contraception * Prior chemotherapy or radiation therapy * Severe pulmonary disease as judged by the principal investigator (PI) including chronic obstructive pulmonary disease (COPD) and asthma * Active infection requiring treatment with intravenous therapy * Presence of central nervous system (CNS) lymphoma * Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix) * Active hepatitis B or C infection
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Study Objectives The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma Conditions: Advanced Solid Malignancies, Malignant Lymphoma Intervention / Treatment: DRUG: AZD1208 Location: United Kingdom, Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study * Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist * Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks. * Patients who have at least one lesion that can be accurately assessed Exclusion Criteria: * Patients who have recently received or are receiving prohibited medications or treatments * Patients who have any unresolved side effects of previous treatments * Patients who have spinal cord compression or brain metastases * Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus \[HIV\] infection) * Patients with significant abnormal ECG findings
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Study Objectives This study will examine a new imaging technique called digital breast tomosynthesis (DBT) compared to standard mammography in women under 60 presenting with signs of breast cancer. The reason that we need to do this study is that standard mammography fails to detect the cancer in approximately 20% of these women because younger women have denser breast tissue. We hope that DBT will be more sensitive in detecting breast cancer than standard mammography. Conditions: Breast Cancer Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Female * Under 60 years old * Clinical or ultrasound suspicion of breast cancer Exclusion Criteria: * Unable to give informed consent * Male * Obvious advanced breast cancer * Obvious medical problems meaning surgery would not be an option
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Study Objectives Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of T staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. All these will translate into better clinical outcome, and also avoid unnecessary surgery in situations of unresectable cancers. Conditions: Pancreatic Cancer Location: Singapore Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Consecutive patients over a 1-year period referred for EUS examination due to suspected pancreatic lesions will be enrolled. * Age 21 years and above. * Ability to provide informed consent Exclusion Criteria: Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded. These conditions are: * Right-to-left, bi-directional, or transient right-to-left cardiac shunts; * Worsening or clinically unstable congestive heart failure; * Acute myocardial infarction or acute coronary syndromes; * Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval; * Respiratory failure; * Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature; * Hypersensitivity to DEFINITY™ or its components.
8,529
Study Objectives The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug can be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or pancreatic cancer without causing unacceptable side effects. Conditions: Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Pancreatic Cancer Intervention / Treatment: DRUG: ABR-217620 Location: United Kingdom, United States, Norway Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Patients with histologically or cytologically confirmed non-small cell lung cancer, which is refractory to (progressed on or following) currently available standard therapies. Patients must have received (or declined) at least one standard regimen for advanced/metastatic disease. * ECOG performance status of 0 or 1. * Adequate bone marrow function as defined by absolute neutrophil count greater than or equal to 1500/mm3, and platelets greater than or equal to 100,000/mm3, and hemoglobin greater than or equal to 10 g/dL. * Adequate renal function: creatinine less than or equal to 1.5 x upper limit of normal. * Adequate hepatic function: bilirubin less than or equal to 2 x upper limit of normal, and SGOT (S-ASAT) and SGPT (S-ALAT) less than or equal to 2.5 x upper limit of normal. * Life expectancy greater than 3 months. Exclusion Criteria: * Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used. * A serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment. * History of or any concurrent malignancy, with the exception of the following malignancies, which may still be included: non-melanoma skin cancer, cervical cancer in situ, DCIS or LCIS of breast, past history of resected melanoma without clinical evidence of recurrent melanoma, past history of prostate cancer without clinical evidence of disease (includes patients receiving hormonal therapy). * History of brain metastases, unless stable for more than 4 weeks, and not requiring steroid therapy and without clinical symptoms of brain metastases. * Acute illness or evidence of infection, including unexplained fever (temperature greater than 100.5 degrees Fahrenheit or 38.1 degrees Celsius). * Significant symptomatic cardiac disease including: history (within the past 6 months) or current unstable angina, congestive heart failure, or myocardial infarction; or patients with uncontrolled hypertension, or hypertension that is controlled only with multiply drugs (control by monotherapy is permitted). * History of or current arrhythmias requiring treatment, with the exception of non-specific, asymptomatic ST-T wave changes or extrasystoles. * History of cerebrovascular accident within the past 5 years. * Seizure disorder requiring therapy. * Treatment with beta-blockers, including topical therapy for glaucoma, during the 6-day treatment period (5 days' treatment + 1 day in patient follow-up), and within five days prior to start of treatment. * Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment. * Treatment with systemic or inhaled corticosteroids within 2 weeks prior to the start of treatment. * Treatment with anticoagulants, except when used to maintain the patency of a central venous line. * Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis. * Chemo/radio/immunotherapy less than 4 weeks (6 weeks for mitomycin C and nitrosoureas) before start of treatment. * Major surgery less than 3 weeks. * Known positive serology for HIV (patients with a known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in the immunocompromised host). * Known chronic Hepatitis B or C. * Previous exposure to murine monoclonal antibody (with HAMA titer above detection limit at baseline) or known hypersensitivity to murine proteins. * Patients currently on renal dialysis treatment. * Known allergy or hypersensitivity to aminoglycosides e.g. kanamycin.
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Study Objectives The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine plus rituximab, to subjects with select relapsed/refractory hematologic malignancies. Conditions: Lymphoma, Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, T-cell Lymphoma Intervention / Treatment: DRUG: IPI-145, DRUG: Rituximab, DRUG: Bendamustine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Dose Escalation Phase Arm 1 and Arm 2: Limited to subjects diagnosed with low grade CD-20 positive B-Cell NHL with at least one prior anticancer treatment. * Dose Expansion Phase Arm 1 Cohort A: Limited to subjects with CD-20 positive CLL with at least one prior anticancer treatment. Arm 1 Cohort B: Limited to subjects with diagnosis of CD-20 positive NHL with at least one prior anticancer treatment. Arm 2 Cohort A: Limited to subjects with CD-20 positive CLL with at least one prior anticancer treatment. Arm 2 Cohort B: Limited to subjects with diagnosis of CD-20 positive NHL with at least one prior anticancer treatment. * Disease status requirement: * CLL subjects: symptomatic disease that mandate treatment; * Indolent NHL subjects: symptomatic disease requiring treatment according to the clinical judgment of the investigator; * Other lymphoma subjects: disease requiring treatment according to the judgment of the investigator. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤2. * Subject must have measurable disease using the disease-specific response criteria for NHL or CLL * Age ≥ 18 years. * Subject has recovered from all clinically significant toxicities related to prior antineoplastic therapies with the exception of alopecia and bone marrow and organ functions. * Adequate organ system function ≤2 weeks prior to Day 1, defined as follows: * Absolute neutrophil count (ANC) ≥1.0 x 109/L unless related to underlying CLL or indolent NHL bone marrow involvement, and then ANC ≥500 x 109/L permitted. * Platelets ≥100 x 109/L unless related to underlying CLL or indolent NHL bone marrow involvement, and then platelets ≥75 x 109/L permitted. * Subjects receiving IPI-145 plus rituximab with bone marrow involvement may enroll with platelets ≥40 x 109/L. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x ULN and total bilirubin ≤1.5 times the upper limit of normal (ULN) (except for subjects with Gilbert's disease) * Serum creatinine ≤1.5 x ULN * Life expectancy of ≥12 weeks. * Women of child-bearing potential (WCBP) must have a negative serum or urine pregnancy test. * Ability to understand the nature of this study and give written informed consent. Exclusion Criteria: * Prior allogeneic hematopoietic stem cell transplant (HSCT). * Prior autologous transplant or radioimmunotherapy ≤6 months prior to the first dose of trial treatment. * Subject has a high grade lymphoma such as Burkitt's, lymphoblastic or small non-cleaved cell lymphomas. Subjects with intermediate grade lymphoma (such as diffuse large B-cell lymphoma) are eligible. * Subjects with diffuse B-cell lymphoma must either not be eligible for autologous bone marrow transplant (BMT) or relapsed after autologous BMT. * More than three previous cytotoxic chemotherapy regimens for subjects treated on the arm containing bendamustine. * Subjects who have had a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibodies. * Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), radiation therapy (other than whole brain irradiation \[WBI\]) surgery or ablative therapy or investigational drugs/devices ≤28 days before first dose of trial treatment. * Subjects receiving high doses of corticosteroids must have been tapered to a stable dose at least 7 days before the first dose of trial treatment. * Tyrosine kinase inhibitor within 7 days prior to the first dose of trial treatment. * Subjects with overt leptomeningeal leukemia or central nervous system (CNS) lymphoma. Subjects must be free of CNS disease for a minimum of 2 months. Subjects with symptoms of CNS disease must have a negative diagnostic lumbar puncture prior to study enrollment. * Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months. * Baseline QTcF >480 ms. Note: This criterion does not apply to subjects with a left bundle branch block. * Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria: * Have been on a stable dose of anticoagulation for <1 month. * Have had a Grade 2, 3 or 4 hemorrhages in the last 30 days. * Are experiencing continued symptoms for their venous thromboembolic event. * Subjects with a history of liver disease as a result of alcohol abuse, chronic hepatitis, or other chronic liver disease (other than metastatic disease to the liver). * Subjects with positive HBsAg, HBcAb or HCV are excluded. * Subjects with a history of tuberculosis within the preceding two years. * Prior surgery affecting drug absorption or any gastrointestinal dysfunction that could alter drug absorption. * Subjects with a known hypersensitivity to bendamustine or rituximab. * Presence of active infection within 72 hours of treatment. Subjects with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications. * Known diagnosis of human immunodeficiency virus (HIV). * Concurrent administration of medications or foods that are strong or moderate inhibitors or inducers of CYP3A. * Women who are pregnant or lactating. * 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 or would impart excessive risk associated with study participation that would make it inappropriate for the subject to be enrolled. * Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
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Study Objectives To investigate the body fat distribution in chinese women with polycystic ovary syndrome (PCOS) and the association of those distribution with metabolic parameters, microeconomics, hormone profiles and psychological state. Conditions: Polycystic Ovary Syndrome (PCOS) Intervention / Treatment: OTHER: Clinical data collection Location: China Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Age 18 to 45 years * For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL Exclusion Criteria: * Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia. * Type I diabetes or not well controlled type II diabetes * Stage 2 hypertension (resting blood pressure ≥160/100mmHg) * Psychiatric diagnoses or using psychiatric medications including antidepressants * Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months. The control group are non- PCOS normal women (age 18-45) and meet the same exclusion criteria.
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Study Objectives Vertebral column is the most prevalent location of bone metastases. Besides axial pain, vertebral metastases cause pathological fracture and neurological dysfunction by spinal cord compression. Although the median overall survival of patients with bone metastases is only 7-9 month, half of them live longer and will require palliative treatment for their symptoms. Treatment options are radiotherapy and /or surgical treatment such as laminectomy, vertebroplasty or kyphoplasty. Various studies have shown the superiority of postoperative external beam radiotherapy after kyphoplasty in spinal metastases compared to surgery or radiotherapy alone. Nevertheless postoperative radiation schedules last 2-4 weeks. Moreover many patients present visceral and bone metastases simultaneously and require urgent systemic therapy. However, due to potentiated toxicity, concurrent therapy with full dose chemotherapy and radiotherapy is rarely possible. The investigators have therefore established a novel method for intraoperative radiotherapy (IORT) during kyphoplasty which enables immediate stability, sterilization of the metastasis and immediate initiation of chemotherapy. The kyphoplasty itself is performed according to the standard procedure with some minor modifications. In short under general anaesthesia, a bipedicular approach into the affected vertebra is chosen with insertion of specially designed metallic sleeves to guide the electron drift tube of the miniature X-ray generator (INTRABEAM®). To perform the IORT during a kyphoplasty with this device a new applicator was designed. This sterile applicator consists of a plastic head, which is needed to attach it to the X-ray source and a stainless steel tube. This tube protects the probe from bending. Under fluoroscopic guidance the applicator including the drift tube is guided through the metallic sleeves in the vertebral body. A dose of 8 Gy in 5 mm distance is delivered. After IORT the INTRABEAM system is removed. The kyphoplasty balloon is inflated and PMMA-cement is injected. Afterwards the sleeves are removed and the wound is closed as usual. Aim of this study is the definition of the maximum tolerable dose (MTD) for IORT during a kyphoplasty using specific MTD-criteria and evaluating the effectiveness of this combined treatment procedure. To determine the MTD 3 levels with increasing doses are planned: 8 Gy in 5 mm distance, 8 Gy in 8 mm distance and 8 Gy in 10 mm distance. Conditions: Tumors Intervention / Treatment: RADIATION: intraoperative radiotherapy Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * ≥ 50 years * Karnofsky Index ≥ 60 * histological or by imaging proven spinal metastases (2 cm diameter as the upper limit) inferior TH 3, which are accessible for kyphoplasty * written informed consent obtained * use of adequate contraceptive method by female patients of reproductive potential to minimize risk of pregnancy Exclusion Criteria: * uncontrolled intercurrent medical disorder - including but not limited to ongoing or active infection (including infections in the area of the treated spinal segment, for example, spondylitis / osteomyelitis / skin infections) or mental illness / social situation which affect the compliance of study requirements * prior radiation of the same vertebra * patients could not receive anaesthesia or surgery for medical reasons * history of coagulation disorder associated with bleeding * existing contraindications for MRI- or CT-scans * pregnant or breast-feeding women
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Study Objectives Rationale: Patients diagnosed with hepatocellular carcinoma (HCC) at an intermediate or advanced stage (according to the BCLC classification system) are not amenable of curative treatment. According to EASL and AASLD guidelines patients with an intermediate stage HCC are treated with trans-arterial chemoembolization (TACE) while patients with an advanced stage HCC are treated with molecular targeted drugs or other combinations according to their liver function. The median survival expected for patients in intermediate-advanced stages ranges from 11 to 20 months. Purpose of the Study: The purpose of this prospective phase II study is to determine whether or not Radioembolization with Yttrium-90 microspheres (TheraSphere®) provides an anti-tumoral effect and a sensible benefit in terms of time-to-progression (TTP) and survival in patients with good liver function (Child A-B7) and a confirmed diagnosis of Intermediate or Advanced (because of the presence of neoplastic portal thrombosis) Hepatocellular Carcinoma (HCC). Conditions: Hepatocellular Carcinoma, Liver Cancer Intervention / Treatment: DEVICE: Yttrium-90 microspheres (Therasphere MDS Nordion) Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Diagnosis of HCC confirmed by histology or non-invasive criteria (EASL/AASLD) * Intermediate stage (BCLC-B) HCC: patients with a large or multinodular HCC (single HCC > 5 cm or multiple HCC defined as > 3 nodules > 3 cm), a Child Pugh class A or B7 and no cancer related symptoms (PS=0-1). * Advanced stage (BCLC-C) HCC: patients with hepatic vascular involvement (at any tumor number and diameter), a Child Pugh class A or B7, no cancer related symptoms (PS=0-1) and absence of extra-hepatic tumor spread. * Cancer-related symptoms within the ECOG 0-1 score * Liver function within Child B-7 class * Platelets > 50.000/µL * WBC > 1500/µL * AST/ALT < 5 times the upper limit of normal (U/L) * Creatinine < 2.0 mg /dL * No indication for any possible curative treatment after multidisciplinary assessment (resection, ablation, transplantation) * Signed informed consent Exclusion Criteria: * Child-Pugh class higher than B-7 at entry * ECOG performance score ≥ 2 at entry * Tumor volume ≥ 50% of liver volume * Extrahepatic tumor spread * Pulmonary insufficiency * Life expectancy of less than 3 months due to HCC or less than 6 months due to any other disease * Previous chemoembolization procedure (TACE) * Evidence on 99mTc-MAA scan of vascular shunts that can not be corrected by angiographic coil embolization * Evidence on 99mTc-MAA scan of lung shunting, with a potential absorbed dose of radiation to the lungs > 30 Gy
1,016
Study Objectives Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas. Conditions: Colorectal Cancer Intervention / Treatment: PROCEDURE: colonoscopy, PROCEDURE: faecal test Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * asymptomatic 55-64 years subjects Exclusion Criteria: * already studied for colorectal cancer, severe comorbidities
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Study Objectives To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: PF-06863135 monotherapy IV or SC, DRUG: PF-06863135 + dexamethasone, DRUG: PF-06863135 + lenalidomide, DRUG: PF-06863135 + pomalidomide Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE
Inclusion Criteria: * Relapsed/refractory multiple myeloma * Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody * Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma) * Adequate bone marrow, hematological, kidney and liver function * Resolved acute effects of any prior therapy to baseline severity * Not pregnant Exclusion Criteria: * Recent history of other malignancies * History of active autoimmune disorders * Any form of primary immunodeficiency * Active and clinically significant bacterial, fungal, or viral infection * Evidence of active mucosal or internal bleeding * History of severe immune-mediated adverse event with prior immunomodulatory treatment * Major surgery within 4 weeks of study treatment start * Radiation therapy within 2 weeks of study treatment start * History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment * Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry * Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy * Requirement for systemic immune suppressive medication except as permitted in the protocol * Current requirement for chronic blood product support
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Study Objectives Only a few clinical trials evaluating the potential benefits of exercise have been conducted in adolescents and young adults (AYA) with cancer and, no prior studies have evaluated the potential effects of 'cybercycling' (exergaming on a stationary bike) in AYA cancer survivors. Therefore, the study aims to conduct a pilot trial to determine feasibility (adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise program on fitness, body composition, quality of life, sleep and cognition. Conditions: Adolescent and Young Adult Cancers Intervention / Treatment: BEHAVIORAL: CyberCycling, BEHAVIORAL: Stretching, BEHAVIORAL: Resistance Bands Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * histologically confirmed cancer * completed primary treatment * approved to be contacted by the treating oncologist/nurse practitioner * meet screening criteria Exclusion Criteria: * patients unable to provide informed consent * patients not available for follow-up testing * patients with any pre-existing medical conditions that would be a contraindication to exercise.
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Study Objectives This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma. Conditions: Metastatic Cancers Location: Spain Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma * Written informed consent granted Exclusion Criteria: * Do not fulfill one or more inclusion criteria
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Study Objectives Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group . Conditions: Acute Leukaemia in Relapse Intervention / Treatment: OTHER: Supportive /palliative care intervention Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * > 18 years old * acute lymphoblastic or myeloblastic leukemia at first relapse and diagnosed within 8 weeks before inclusion. * Patients in whom a curative strategy (transplant) is not considered. * patients older that 75 years at the diagnosis * informed signed consent Exclusion Criteria: * unable to answer the questionnaire * psychiatric disorders other than depression * persons under guardianship
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Study Objectives This phase I/II trial studies the side effects and best dose of leflunomide in treating patients with multiple myeloma that has come back (relapsed) or has not responded to previous treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Conditions: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: Leflunomide, OTHER: Pharmacological Study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE
Inclusion Criteria: * All subjects must have the ability to understand and the willingness to sign a written informed consent * Patients must have a life expectancy of > 3 months * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Patients must have a diagnosis of multiple myeloma * Serum M-protein >= 0.5 g/dL * Urine M-protein >= 200 mg/24 hr * Serum free light chain >=10 mg/dL provided the free light chain (FLC) ratio is abnormal * 10% plasma cells in bone marrow * Patients must be relapsed or are refractory to at least 3 prior lines of therapy, including both a proteasome inhibitor an immunomodulatory drug (IMiD), and for whom a transplant is not recommended (induction therapy and stem cell transplant +/- maintenance will be considered as one regimen) * At least 2 weeks from prior therapy to time of start of treatment; prior therapy includes steroids (except prednisone or equivalent - up to 10 mg per day is allowed) * Platelet count >= 50,000/uL; platelet transfusions are not allowed within 14 days of platelet assessment * Absolute neutrophil count (ANC) >= 1000/mm\^3; growth factor is not permitted within 14 days of neutrophil assessment * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.0 x upper limit of normal (ULN) * Total Bilirubin < 1.5 x ULN * Calculated creatinine clearance (CrCl) >= 30 mL/min per 24 hour urine collection or the Cockcroft-Gault formula * Negative serum or urine beta-human chorionic gonadotropin (B-HCG) test (female patient of childbearing potential\* only), to be performed locally within the screening period * Negative for tuberculosis antigen (e.g. T-Spot test) * Negative for hepatitis A, B, or C infection * Adequate pulmonary function as defined by forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted by pulmonary function testing * Agreement by females of childbearing potential\* and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for three months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately \* A female of childbearing potential is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months Exclusion Criteria: * Prior treatment with leflunomide * Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period * Current or planned growth factor or transfusion support until after initiation of treatment; if growth factor or transfusion support is provided between screening and start of treatment, the participant will no longer be eligible * Prior diagnosis of rheumatoid arthritis * Prior allogenic transplant * Acute active infection requiring systemic therapy within 2 weeks prior to enrollment * Pre-existing liver disease * Known human immunodeficiency virus (HIV) infection * History of allergic reactions attributed to compounds of similar chemical or biologic composition to leflunomide or cholestyramine * Non-hematologic malignancy within the past 3 years aside from the following exceptions: * Adequately treated basal cell or squamous cell skin cancer * Carcinoma in situ of the cervix * Prostate cancer < Gleason grade 6 with a stable prostate specific antigen (PSA) * Successfully treated in situ carcinoma of the breast * Clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or the patient's ability to give informed consent * Pregnant women and women who are lactating; breastfeeding should be discontinued if the mother is enrolled on this study * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc * NONCOMPLIANCE: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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Study Objectives The purpose of this study is to study whether immune cells capable of killing tumors that express proteins associated with paraneoplastic neurologic syndrome (PNS) can be found in small cell lung cancer and ovarian cancer patients. The presence of these cells may play a role in tumor immunity in these patients. The protocol involves neurological examinations and collection of blood. Conditions: Cancer Location: United States Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Males and females ages 25 -75 * If leukapheresis: Hepatitis B surface antigen negative if tested\* Hepatitis C antibody negative if tested\* HIV antibody negative if tested\* Venereal disease reaction level (VDRL) negative if tested\* No known IV drug users Hemoglobin > 8.5 White blood cell count > 3,800 Platelets > 120,000 International normalized ratio (INR) < 2 (verified only if clinically indicated) * If large blood draw (1/2 to 1 unit) in lieu of leukapheresis: Hepatitis B surface antigen negative if tested\* Hepatitis C antibody negative if tested\* HIV antibody negative if tested\* VDRL negative if tested\* No known IV drug users HgB > 10.0 WBC > 3,800 Platelets > 120,000 INR < 2 (verified only if clinically indicated) Exclusion Criteria: No known neurologic disease 2. No known central nervous system (CNS) metastasis on clinical exam 3. No chemotherapy within 1 month 4. No New York Heart Association class III/IV status 5. No pulmonary disease which limits daily activities 6. No anticoagulation therapy
37,065
Study Objectives 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. Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: Sentinel Node Biopsy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
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
161
Study Objectives The study is a first in man, dose escalation study to evaluate the safety, tolerability and how the drug works in the body in patients with all solid tumours. The aim of this study is to determine the most effective dose of the study drug that can then be further investigated in patients with advanced melanoma. Conditions: Melanoma, Cancer Intervention / Treatment: DRUG: CCT3833 Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * 18 years or over. * Written (signed and dated) informed consent and willing and capable of co-operating with study procedures, treatment and follow-up. * Histologically proven advanced or metastatic solid tumours. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least 12 weeks. * Haematological and biochemical indices (within 7 days before the first dose of CCT3833) within the ranges shown below: 1. Haemoglobin (Hb) ≥ 9.0 g/dL. 2. Absolute neutrophil count ≥ 1.5 x 109/L. 3. Platelet count ≥ 100 x 109/L. 4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x (ULN) (or ≤ 5 x ULN if elevated due to tumour). 5. Calculated creatinine clearance > 50 mL/min (based on Cockcroft-Gault calculation). * Negative pregnancy test for females of child-bearing age. Inclusion criteria: dose expansion cohort Patients must meet ALL of the above criteria and additionally meet the following criteria: * Histologically proven locally advanced (unresectable) or metastatic melanoma. * Documented presence of either BRAF or RAS mutations, as established by validated mutation testing from tumour biopsy. * Evidence of measurable disease (according to RECIST v1.1) Exclusion Criteria: Patients who meet ANY of the following criteria will not be eligible to participate. Patients who have had any of the following within the last 4 weeks: * Radiotherapy (except for palliative reasons), endocrine therapy (except luteinizing hormone releasing hormone (LHRH) agonists for prostate cancer), immunotherapy or chemotherapy (6 weeks for nitrosoureas, Mitomycin-C and 4 weeks for other investigational medicinal products (IMP)) before treatment. (For patients recruited to Part B (dose expansion) from Part A (dose escalation), prior treatment with CCT3833 during Part A (dose escalation) is permissible.) * Major surgery within the last four weeks. * Has been a participant in another interventional research study (involving an IMP) within the last 4 weeks, or plans to participate in one whilst taking part in this study. Participation in an observational study would be acceptable. Patients who have any of the following: * High medical risk because of non-malignant systemic disease including active, uncontrolled infection. * Known allergy to any pharmaceutical excipients. * Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). Testing for these viruses is not mandatory. * Impaired cardiac function or clinically significant cardiac diseases, including any of the following: 1. History or presence of ventricular tachyarrhythmia. 2. Presence of unstable atrial fibrillation (ventricular response > 100 bpm); patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria. 3. Repeated presence of a prolonged QTc interval > 450 ms at baseline (as calculated by Fridericia method). 4. Unstable angina pectoris or acute myocardial infarction in the last 12 months prior to starting study drug. 5. Other clinically significant heart disease (e.g., symptomatic congestive heart failure (LVEF < 50%); uncontrolled arrhythmia; history of labile hypertension or poor compliance with an antihypertensive regimen). * Uncontrolled hypertension that remains uncontrolled on > 1 antihypertensive agent. * Symptomatic brain metastases (if present they must have been stable for > 3 months). Such patients must not be requiring systemic corticosteroid or enzyme-inducing anticonvulsant therapy. * Inability to take oral medication; impairment of GI function or GI disease that could interfere with drug absorption. * Have taken potent inducers/inhibitors of CYP3A4 and CYP2C8 liver enzymes within 2 weeks of the first administration of study drug, or have conditions that require the concomitant usage of such drugs during the course of the study. * Are taking warfarin as an oral anticoagulant; patients anticoagulated with low molecular weight heparin are not excluded from the trial. * Female patients who are pregnant or lactating, or have the ability to become pregnant. However, those female patients who have a negative serum or urine pregnancy test before enrolment and are using highly-effective contraception during the study and for 6 months afterwards, are considered eligible. Highly-effective contraception methods include: 1. Total abstinence. 2. Male or female sterilization. 3. A combination of any two of the following: i. Oral, injected or implanted hormonal contraception. ii. Placement of an intrauterine device (IUD) or intrauterine system (IUS). iii. Barrier methods of contraception: condom or diaphragm with spermicidal foam/gel/film/cream/vaginal suppository. * Male patients with partners of child-bearing potential, unless they agree to take measures not to father children by using one form of highly effective contraception as defined above, during the study and for 6 months afterwards. Men with pregnant or lactating partners should be advised to use barrier method contraception to prevent exposure to the foetus or neonate. * Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical study.
5,675
Study Objectives This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant. Conditions: Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, PROCEDURE: Leukapheresis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * HIV positive * Treatment with highly active antiretroviral therapy (HAART) for at least 1 month * Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy * Hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated * Approval for allogenic regimen given at Patient Care Conference * DONOR: Autologous or allogeneic gene modified cells allowed Exclusion Criteria: * A medical history of noncompliance with HAART or medical therapy * Inability to provide informed consent * DONOR: Allogeneic donors must not have HIV infection
6,873
Study Objectives This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors Conditions: Solid Tumors Intervention / Treatment: DRUG: EC D-3263 HCl Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists * measurable or evaluable disease * >= 18 years of age * ECOG of 0, 1 or 2 * no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot LHRH agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of EC D-3263 HCl Exclusion Criteria: * Clinically significant coronary artery disease or conduction system abnormality * Coagulation disorder * Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl * Any major surgery within 28 days prior to receipt of EC D-3263 HCl
9,692
Study Objectives Patients with metastatic cancer have a substantial symptom burden and may receive aggressive care at the end of life. There is evidence that the use of chemotherapy near the end of life is not related to its likelihood of providing benefit and the overuse of aggressive anticancer therapies near the end of life may result in more toxicity than clinical benefit. Moreover, proposing new lines of treatment after successive therapeutic failures may be a way of avoiding discussion of prognosis and advance care planning. It has been proposed that systems not providing overly aggressive care near the end of life would be the ones in which less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the first consultation between patient and oncologist is ruled in France by the first "Plan Cancer" and the "Dispositif d'annonce" (announcement planning). Oncologists are supposed to explain the diagnosis of cancer and to present a treatment plan. In routine practice for metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and its side effects are explained. The use of chemotherapy has been associated with the worsening of two major competitive life-threatening conditions for cancer patients: cachexia and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is hardly explained in routine practice. This study proposes to examine in a monocentric interventional prospective randomized trial, the impact of a particular way for the oncologist to present chemotherapy at the diagnosis stage on the easiness of timely chemotherapy interruption at the end of life. The main objective is to determine whether or not the explanation of the potential role of anticancer chemotherapy in worsening life-threatening conditions impacts the proportion of patients receiving chemotherapy in the last 30 days of life compared with usual presentation. Secondary objectives are to determine the impact of this communication strategy on overall survival and other indicators of aggressiveness of care and palliative care resources use. The hypothesis is that the intervention will allow 15% of patients receiving anticancer therapy during the last 30 days of life, as compared to 30% in the control group. The investigators expect that the intervention evaluated in this study will reduce the rate of patients receiving chemotherapy during the last 30 days of life hopefully improving the quality of end of life care. A secondary objective is overall survival and this study will therefore verify that the intervention arm is not associated with poorer overall survival. But more probably investigators expect patients in the intervention arm to have an improved overall survival mainly link to a decrease in harms due to chemotherapy given near the end of life and to better palliative care. In effect the hypothesis is that showing the life-threatening risks associated with chemotherapy and thus reducing for patients the importance of this treatment will leave room for improved palliative care as shown notably by earlier and more frequent referral to palliative care specialists. If this trial is positive, it will prove the capital role of patient-doctor communication in cancer care and that few differences in communication strategy could improve end of life care and maybe even survival. The impact on the oncology community would be major since the intervention could be easily transposed in all practices at no additional cost. It would also emphasize the importance of communication skills and human relationship in the very technical field of medical oncology. Conditions: Stage IV Lung Cancer Intervention / Treatment: BEHAVIORAL: Truthful information on chemotherapy risks, BEHAVIORAL: Standard of information Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE
Inclusion Criteria: * stage IV lung cancer, histologically proven * > 18 years old * diagnosed during the last 8 weeks * systemic therapy indicated Exclusion Criteria: * prior systemic therapy for metastatic disease * comorbidity not compatible with the inclusion according to the investigator * patient has not given its non-objection or not being able to give * patient unaffiliated or not beneficiary of a social security scheme
13,417
Study Objectives The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese female subjects. Conditions: Uterine Leiomyomata (Fibroids) Intervention / Treatment: DRUG: PRA-027 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE
INCLUSION CRITERIA * Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. * Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at least 45 kg. * Healthy as determined by the investigator on the basis of screening evaluation. EXCLUSION CRITERIA * Any significant cardiovascular, hepatic, renal, respiratory, gynecologic gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. * Use of any investigational drug within 90 days before study day 1, use of any prescription drug within 30 days before study day 1, consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages within 48 hours before study day 1, consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1, use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1, or the donation of blood within 90 days before study day 1.
11,653
Study Objectives This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs \>1), prior gastrectomy, and center. Conditions: Gastric Cancer Intervention / Treatment: DRUG: S-1, DRUG: S-1 plus CDDP, DRUG: 5-FU plus CDDP Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Non-prior chemotherapy treated advanced gastric adenocarcinoma * Age 18 and over * Performance status 0, 1, or 2 (ECOG) * Life expectancy 3 months * Hematopoietic WBC lower limit of normal-12,000/mm\^3 Absolute granulocyte count ≥ 2,000/mm\^3 Platelet count ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL * Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL * Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min Exclusion Criteria: * Interstitial pneumonia, pulmonary fibrosis * Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure * Intestinal paralysis, intestinal obstruction, uncontrollable diabetes
1,021
Study Objectives This observational clinical cohort study aims to evaluate the clinical utility of LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will enable further developments in scanning protocols and software, and clearly define the relevance of applying this technology as part of the pre-operative assessment of the patient being considered for liver resection or TACE. Conditions: Liver Cancer, Surgery, Liver Regeneration, Colorectal Cancer Metastatic Intervention / Treatment: DIAGNOSTIC_TEST: Multiparameter magnetic resonance imaging Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Patients being considered for liver resection Exclusion Criteria: * i. Patients under the age of 18 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Persons unable to have an MRI scan (including but not limited to claustrophobia, implanted metallic devices, metal foreign body) iv. Adults with incapacity v. Non-provision of consent
19,457
Study Objectives The study wants to define the efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal cancer. Conditions: Palliative Care Intervention / Treatment: RADIATION: Short course radiotherapy Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * histologically proven advanced esophageal cancer * excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status * age > 18 years * Eastern Cooperative Oncology Group (ECOG) <3 Exclusion Criteria: * prior radiotherapy to the same region
23,939
Study Objectives The AML18 Pilot Trial will evaluate the feasibility of three interventions that are planned to be included in the forthcoming NCRI AML18 Trial. One intervention will be to evaluate combining the Tyrosine Kinase Inhibitor AC220 with three courses of standard DAE (Daunorubicin, Ara-C, Etoposide). AC220 will be given following each treatment course, daily by mouth for 7, 14 or 21 days. AC220 will be evaluated at 3 dose levels of 60, 90 and 135 mg flat dose. A 4th dose level of 40 mg will be introduced should patients not respond well to 60 mg. The second intervention to be tested is the combination of the CXCR4 inhibitor Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin, Clofarabine). Patients/investigators will be able to choose which intervention to enter. Depending on recruitment requirements, only one intervention might be available at any one time. The third intervention Patients will receive 3 treatments of 100 mg of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib. Conditions: Acute Myeloid Leukaemia, High Risk Myelodysplastic Syndrome Intervention / Treatment: DRUG: Plerixafor, DRUG: AC220, DRUG: Ganetespib Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * They have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia or CML in blast crisis as defined by the WHO Classification (Appendix A) - this can be any type of de novo or secondary AML - or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2). * Serum creatinine ≤ 1.5 × ULN (upper limit of normal) * White cell count of <30 x 109/L at diagnosis (for Plerixafor option only). If WCC is >30 x 109/l patients in the Plerixafor pilot should have the WCC reduced to <30 x 109/L using Hydroxycarbamide to avoid the risk of hyperleucocytosis * Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits, and every effort should be made to keep potassium at institutional normal limits, and every effort should be made to keep potassium concentrations above 4.0 mEq/dL, and serum calcium at normal concentration. * Total serum bilirubin ≤ 1.5 × ULN (upper limit of normal) and serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 × ULN * Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP). * Over 60 years of age * Provided written informed consent Exclusion Criteria: * They have previously received cytotoxic chemotherapy for AML. \[Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion\]. * They are in blast transformation of chronic myeloid leukaemia (CML). * They have a concurrent active malignancy excluding basal cell carcinoma. * They are pregnant or lactating. * They have Acute Promyelocytic Leukaemia * Known infection with human immunodeficiency virus (HIV) Patients are not eligible for the AC220 option if they have: * Uncontrolled or significant cardiovascular disease, including : * A myocardial infarction within 12 months * Uncontrolled angina within 6 months * Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is ≥ 45% (or institutional lower limit of normal value). * Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes \[TdP\]); any history of arrhythmia will be discussed with the Sponsor's Medical Monitor prior to patient's entry into the study. * Prolonged QTcF interval on pre-entry ECG (≥450 ms) - this will be the average of 3 readings within a 2 hour period. * Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker). * Heart rate < 50/minute on pre-entry ECG * Uncontrolled hypertension * Obligate need for a cardiac pacemaker * Complete left bundle branch block * Atrial fibrillation
3,943
Study Objectives he percentage of retroperitoneal sarcomas (RPS) among all soft tissue sarcomas ranges from 10%-15%. Surgery remains the gold standard for RPS. In this study, we analyzed the impact of surgical treatment for primary RPS on recurrence and overall mortality at a Chinese institution and identified and evaluated prognostic variables. Conditions: Primary Retroperitoneal Sarcoma Intervention / Treatment: OTHER: WANG DAORONG Location: China Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * The inclusion criteria were as follows: (1) diagnosis of primary retroperitoneal sarcoma, (2) pathological conformity, (3) no prior surgical resection, (4) complete clinicopathological data, and (5) age of ≥18. Exclusion Criteria: * Patients with benign retroperitoneal tumors, gastrointestinal stromal tumors, Ewing, desmoid-type fibromatosis, pheochromocytomas/paragangliomas, or any other subtypes other than RPS were not included. The ethics committee of the Northern Jiangsu People's Hospital approved the study.
1,585
Study Objectives The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive or invasive adenocarcinoma following surgical section of Stage 1 NSCLC. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: BIOLOGICAL: QBKPN SSI Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Male or female who is at or above the age of consent * Histologically confirmed original diagnosis of lung cancer * Life expectancy greater than 12 months * ECOG performance status 0, 1, or 2 at screening * Female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug * Male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug Exclusion Criteria: * Extra-thoracic lung cancer progression * Any active malignancies * Any uncontrolled or major organ dysfunction * Any past or current radiation or systemic therapies for the treatment of lung cancer * Known HIV infection or other immunosuppressive disorder * Concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening
26,531
Study Objectives Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor Intervention / Treatment: DRUG: temsirolimus, OTHER: laboratory biomarker analysis, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Histologically confirmed grade 4 astrocytoma at primary diagnosis or recurrence * Gliosarcoma allowed * Evidence of tumor progression by MRI or CT scan after radiotherapy or first-line chemotherapy * Measurable or evaluable disease by MRI or CT scan * Performance status - ECOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 3 times upper limit of normal * Creatinine no greater than 2.0 mg/dL * No myocardial infarction within the past 6 months * No congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias * Cholesterol no greater than 350 mg/dL * Triglycerides no greater than 400 mg/dL * Willing to provide correlative laboratory samples * No uncontrolled infection * No known hypersensitivity to any components of CCI-779, diphenhydramine hydrochloride, or other similar antihistamines * No other medical reason that would preclude diphenhydramine premedication * No other active malignancy * No other severe disease that would preclude study participation * Not immunocompromised unless due to corticosteroids * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * See Disease Characteristics * Prior adjuvant chemotherapy allowed * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No more than 1 prior chemotherapy regimen for recurrent/progressive disease * No prior polifeprosan 20 with carmustine implant (Gliadel) * Must be on fixed dose of corticosteroids (or no corticosteroids) at least 1 week prior to baseline scan * See Disease Characteristics * At least 12 weeks since prior radiotherapy * No prior stereotactic radiosurgery or interstitial brachytherapy unless there is a separate lesion on MRI that is outside of the previously treated field * No prior resection since last chemotherapy or radiotherapy unless there is unequivocal tumor growth on neuro-imaging study since surgery or there is a separate lesion not present in the surgical bed * More than 4 weeks since prior investigational agents
35,920
Study Objectives It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day), i.e. until the cytogenetic analysis. Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator. Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years. Conditions: Chronic Myeloid Leukemia Intervention / Treatment: DRUG: Imatinib mesylate 100 mg (Glivec) Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Old < 18 years, male or female. * Chronic myeloid leukaemia confirmed on the cytogenetic level by the presence of the translocation t(9; 22) (q34; q11) or by the presence of transcript BCR-ABL in the event of absence of description of the translocation t(9; 22) (q34; q11). * Chronic phase of a chronic myeloid leukaemia * Absence of extra-medullary disease (except for a hepatomegaly and/or of a splenomegaly). * Absence of any former treatment of chronic myeloid leukaemia except for hydroxyurea. * Stop of hydroxyurea at least week before the beginning of the imatinib mesylate. * Diagnosis of chronic myeloid leukaemia in chronic phase recent (less than 2 months). * Score of Lansky ≥ 60. * Effective contraception among patients in age to procreate. * Written voluntary informed consent of the two parents or the legal guardian. Exclusion Criteria: * Patients with grade 3 / 4 cardiac disease. * Pathology cardiac, pulmonary, hepatic, renal or neurological of grade > 2 (WHO). * Participation in a clinical trial in the 28 days preceding the beginning by the treatment. * Impossible Follow-up during at least 2 years, patient not compliant. * Expectant mother or nursing.
14,541
Study Objectives The purpose of this study is to find out if the effect of mometasone furoate is any different from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing the skin from peeling, or reducing the amount of irritation the patient reports during treatment. Conditions: Invasive Breast Cancer Intervention / Treatment: OTHER: Eucerin, OTHER: Mometasone Furoate 0.1% Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE
Inclusion Criteria: * Age ≥18 years * Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC * Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT * ECOG Performance Status of 0 or 1 Exclusion Criteria: * Male * Patients with clinical evidence of gross disease * Patients who are pregnant or breastfeeding * Prior radiation therapy to the ipsilateral chest wall or thorax * Patients requiring a chest wall boost * Concurrent chemotherapy (biologic agents are allowed) * Psychiatric illness that would prevent the patient from giving informed consent * Inability or unwillingness to comply with skin care instructions and follow-up * Allergy to either Eucerin or MF * Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT * Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) * Treatment with palliative or pre-operative radiation
17,159
Study Objectives This is an open label phase 1 feasibility and safety dose escalation study. The main objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML. Conditions: Acute Myeloid Leukemia (AML), Leukemic Dendritic Cell Vaccination Intervention / Treatment: BIOLOGICAL: DCP-001 Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Patients with AML, in second complete remission of AML (all FAB-subclasses), not eligible for additional intensification therapies e.g. allogeneic (allo) PSCT \[independent of age\]; OR * Patients with relapse (smouldering) AML not eligible for additional intensification therapies e.g. alloPSCT; OR * Patients with de novo (smouldering) AML not eligible for intensive treatment according to current HOVON trials. * Patients >65 years of age with de novo AML in first CR and off protocol of current HOVON trials. * WHO performance of 0, 1, or 2. * Male or female patients at least 18 years of age and <80 years by date of enrolment. * Patients not treated within current HOVON or other AML trials. * Ability and willingness to give informed consent. * HLA-A2.1 positive patients (only for cohort 4). Exclusion Criteria: * Uncontrolled active infection. * Previous immunotherapy in last 3 months (except for anti-CD33 targeted therapy). * Previous allogeneic PSCT. * Inadequate bone marrow function: absolute neutrophile count (ANC) < 0.5x10E9/L, or platelet count < 20x10E9/L or active bleeding with platelet count > 20x10E9/L. * Inadequate liver function, defined as: * Serum (total) bilirubin > 1.5 x the upper limit of normal (ULN) * AST/SGOT or ALT/SGPT > 2.5 x ULN * Alkaline phosphatase levels > 2.5 times the ULN at baseline. * Inadequate renal function, defined as: * Serum creatinine > 1.5 x ULN * Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. * Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. * Women of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). * Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment. * Minor surgical procedures, within 24 hours prior to the first study treatment. * Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA) / stroke within ≤ 6 months prior to the first study treatment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia requiring medication. * Known hypersensitivity to any of the study drugs or excipients. * Evidence of an other medical condition (such as psychiatric illness, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications. * Eligibility for the HOVON-93 study (intensification program ± allogeneic stem cell transplant).
23,483
Study Objectives To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Acalabrutinib, DRUG: acalabrutinib and pembrolizumab combination Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Women ≥ 18 years of age. * Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. * Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane. * Platinum-sensitive ovarian cancer defined by recurrence or progression of disease > 6 AND < 24 months after completion of the most recent platinum-based therapy. * Measurable disease as defined by RECIST 1.1. * ECOG performance status of 0 or 1. * Completion of all therapy for the treatment of cancer 2 weeks before the start of study therapy and recovered. Exclusion Criteria: * Evidence of platinum-refractory ovarian cancer defined as recurrence or progression during the first 6 cycles of or < 6 months after the beginning of first-line platinum based chemotherapy. * Evidence of platinum-resistant ovarian cancer defined as recurrence or progression within 6 months after completing the most recent platinum-based therapy. * More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer. * Prior malignancy (other than ovarian cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years. * Breastfeeding and pregnant. * Known central nervous system metastases and/or carcinomatous meningitis. * Subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months.. * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction.
2,612
Study Objectives The purpose of this study is to test metallic markers in the breast tissue after breast conserving surgery and to observe the metallic markers' stability in the breast for use as tumor bed markers and positioning devices for radiation treatment. Conditions: Breast Cancer Intervention / Treatment: DEVICE: Non-contrast Computed Tomography (CT) Scans (Metallic Markers), DEVICE: Non-contrast CT Scans (Metallic Markers) Location: United States Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Pathologically confirmed stage 0, I or II bilateral or unilateral breast cancer * Any invasive adenocarcinoma or intraductal carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Surgical treatment with lumpectomy (partial mastectomy) * Successful placement of intraparenchymal metallic markers at last breast surgery * Pathologic tumor size < 5.0 cm (Microscopic multifocality is allowed if total pathologic tumor size is within 5 cm) * Axillary sampling (sentinel node or axillary dissection) performed for axillary nodal staging for all invasive cancers. No axillary sampling is required for ductal carcinoma in situ) * Negative margins of excision. * Radiation treatment to begin within 8 weeks after last surgery or last dose of chemotherapy * Negative post-biopsy mammogram if presented with mammographically detected microcalcifications to ensure removal of suspicious calcifications * History of prior cancers is allowed if patient is without evidence of disease at the time of study entry * Ability to understand and the willingness to sign written informed consent document Exclusion Criteria: * Pregnant or breast feeding at time of study entry. Note: Radiation therapy is teratogenic. Women of child bearing potential must agree to use adequate contraception (abstinence, hormonal or barrier method of birth control) prior to and during study participation. Should a woman become pregnant, she should inform the treating physicians immediately. * Prior in-field irradiation * Stage III or IV breast cancer * Inability to place intraparenchymal metallic markers due to excessive bleeding or other intraoperative complication so that the surgeon deems it inadvisable to place the marker * Pathologic tumor size >= 5 cm * Positive or unassessed margins of surgical resection * Diffuse calcifications on mammogram pre- or post-operatively * Positive or suspicious post-lumpectomy mammogram or breast magnetic resonance imaging (MRI) * Multicentric carcinoma in more than one quadrant of the breast * Non-epithelial breast malignancy; Paget's disease of the nipple * Personal history of collagen vascular disease clinically judged to be a contraindication to radiation therapy * Recurrent disease or prior history of ipsilateral breast cancer * Psychiatric or addictive disorders that impair patient's voluntary ability to participate in informed consent or protocol procedures
23,897
Study Objectives A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of oxygenation and protection of airway damage. However, there is a lack of study about the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation . Conditions: Lung Cancer Intervention / Treatment: PROCEDURE: Vaporizing humidifier Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Allocation: NA Interventional Model: SINGLE_GROUP Masking: DOUBLE
Inclusion Criteria: * ASA physical status class I,II * Unilateral lung lobectomy * Use of one-lung ventilation Exclusion Criteria: * COPD * CAOD * Unstable cardiovascular status * Peak inspiratory pressure > 30 mmHg
11,016
Study Objectives The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following Taxotere based regimens. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Irofulven, DRUG: Prednisone, DRUG: Mitoxantrone, DRUG: Capecitabine, DRUG: Irofulven Location: Chile, United States, Romania, Russian Federation, France, Brazil, Canada, Croatia, Peru Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: To be included in the study, patients must meet the following criteria: * Cancer of the prostate confirmed by a biopsy sample. * 18 years of age or older. * Disease must have spread beyond the prostate as proven by chest x ray, abdominal and pelvic computed tomography (CT) scan, bone scan or clinical examination. * At least one prior hormonal treatment with documented disease progression during hormone therapy. * One previous line of chemotherapy that included Taxotere® (as monotherapy or in combination). This could be in addition to estramustine single agent therapy. * Disease progression during prior Taxotere-based therapy or within 3 months of discontinuing. * Recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery. * Recovered from any toxic effects associated with other investigational drugs, if applicable. * Signed informed consent obtained prior to initiation of any study-specific procedures or treatment. Exclusion Criteria: Patients cannot participate in the study if any of the following apply: * Unable to use prednisone. * Prior treatment with irofulven, capecitabine (Xeloda), continuous/protracted infusion 5-FU (5-fluorouracil) (infusion duration greater than or equal to 24 hours), other fluoropyrimidines or mitoxantrone. * Ongoing treatment with a corticosteroid at a prednisone-equivalent dose > 10 mg/day. * More than 1 prior treatment with either 153Sm or 89Sr, or radioisotope treatment within 8 weeks prior to entering this study. * Initiation of treatment with bisphosphonate agents (e.g., pamidronate, etidronate) within 2 months of entering the study. Pre-existing treatment with bisphosphonate agents is to be continued during this study. * Treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period. Please note: There are additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail and answer any questions. Patients can then decide if they wish to participate.
8,433
Study Objectives This randomized clinical trial studies how well website application (web app) based education and text messaging works in improving skin wound care in patients undergoing Mohs surgery (a surgical procedure used to treat skin cancer). Website application and text messaging based education may help patients stick to wound care instructions before and after surgery, lower anxiety level, and may help monitor their activity. Conditions: Malignant Skin Neoplasm Intervention / Treatment: PROCEDURE: Mohs Surgery, OTHER: Internet-Based Intervention, BEHAVIORAL: Telephone-Based Intervention, OTHER: Educational Intervention, BEHAVIORAL: Exercise Intervention, OTHER: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment, OTHER: Questionnaire Administration, OTHER: Survey Administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE
Inclusion Criteria: * The patient is undergoing Mohs surgery * Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed * The subject is able to complete the study and comply with study instructions, including attending all study visits * The patient has a cell phone capable of receiving text messages Exclusion Criteria: * The patient is not indicated for Mohs surgery * Inability to complete all study-related visits * Non-English speaking patients * The patient cannot receive text messages
8,792
Study Objectives uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma Conditions: Nasopharyngeal Carcinoma Intervention / Treatment: DEVICE: ultrasensitive positron emission tomography Location: China Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Patients must be informed of the investigational nature of this study and given written informed consent. * Aged between 18-65, male/female. * Histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III).. * Fertile women should practice contraception during the study period. * HGB ≥90g/L ,WBC ≥4\*109/L , PLT ≥100\*109/L, * With normal liver function test (ALT and AST ≤2.5\*ULN, TBil ≤2.0\*ULN) * With normal renal function test (serum creatinine ≤1.5\*ULN) Exclusion Criteria: * Women in pregnancy or lactation * Patients with diabetes * Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ. * Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance. * Already involved in other clinical trial. * Mental disorder, civil disability, limited capacity for civil conduct.
10,627
Study Objectives This phase Ib/II trial studies the side effects and best dose of venetoclax when given together with enzalutamide and to see how well they work in treating patients with castration resistant prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgens made by the body. Venetoclax may target a special group of prostate cancer cells that is known to lead to resistance to treatment. Giving enzalutamide and venetoclax may work better in treating patients with castration resistant prostate cancer. Conditions: Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Metastatic Prostate Carcinoma in the Soft Tissue, Prostate Carcinoma Metastatic in the Bone, PSA Progression, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8 Intervention / Treatment: DRUG: Enzalutamide, DRUG: Venetoclax Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Histological or cytological documentation of diagnosis of prostate cancer. * Documented progressive metastatic castrate resistant prostate cancer (mCRPC) based on at least one of the following criteria: * Prostate specific antigen (PSA) progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL. * Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. * Progression of bone disease (evaluable disease) or, new bone lesion(s), by bone scan. * If on an anti-androgen, must have documented progression 6 weeks after stopping anti-androgen therapy. * Willing to undergo a biopsy, if readily available biopsy site present (i.e., nodal or visceral metastasis). * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. * Have testosterone level of < 50 ng/dL. Note: Patients must continue primary androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy. * White blood cells >= 1.5 x 10\^9/L (obtained within 14 days prior to treatment start) * Platelets (UNVPLT) >= 100 x 10\^9/L (obtained within 14 days prior to treatment start) * Hemoglobin (HGB) >= 9 g/dL (obtained within 14 days prior to treatment start) * Potassium (K), total calcium (CA) (corrected for serum albumin), magnesium, sodium (NA) and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start) * Total calcium (CA) (corrected for serum albumin) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start) * Magnesium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start) * Sodium (NA) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start) * Phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start) * Institutional normalized ratio (INR) =< 1.5 (obtained within 14 days prior to treatment start) * Adequate renal function as demonstrated by a creatinine clearance >= 30 mL/min; calculated by the Cockcroft Gault formula * Aspartate aminotransferase (aspartate transaminase \[AST\]) and alanine aminotransferase (alanine transaminase \[ALT\]) =< 3 X upper limit of normal (ULN). If the patient has liver metastases, ALT and AST must still be =< 3 x ULN. Patients with liver metastases and AST/ALT above this limit will not be enrolled (obtained within 14 days prior to treatment start) * Total serum bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert?s syndrome or of non-hepatic origin); or total bilirubin (TBILI) =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert?s syndrome (obtained within 14 days prior to treatment start) * Ability to swallow and retain oral medication (without crushing, dissolving or chewing tablets). * Phase Ib only: Prior enzalutamide treatment and/or other approved treatments for CRPC are acceptable * Phase II only: Participants MUST be treatment naive in the CRPC setting: i.e., no prior exposure to abiraterone acetate other specific CYP-17 inhibitors; no prior exposure to enzalutamide or investigational androgen receptor (AR) targeted agents; and no prior exposure to chemotherapy and or RAD-223. * Sexually active males must agree to use a condom during intercourse while taking the study drug and for at least 3 months after stopping study treatment. Sexually active males should not father a child during this period. A condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. * Participant or legal representative must understand the investigational nature of this study and voluntarily sign and date an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * Phase II only: Prior exposure to abiraterone acetate. * Phase II only: Prior exposure to BCL-2 inhibitors agents like venetoclax. * Phase II only: Prior chemotherapy for castration resistant disease. Chemotherapy given in the castration-sensitive setting is permissible if stopped at least 4 weeks prior to treatment start. * Phase II only: Prior isotope therapy with strontium-89, samarium or radium-223 within 12 weeks of treatment start. * Subject has acute promyeloctyic leukemia * Subject has known active CNS involvement with AML * Participants with known symptomatic brain metastases. * Participant has a concurrent malignancy or malignancy within 3 years of treatment start, with the exception of adequately treated, basal or squamous cell carcinoma, nonmelanomatous skin cancer or curatively resected cervical cancer. * Participant has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory); * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate * Uncontrolled and/or active systemic infection (viral, bacterial or fungal). * Participant has clinically significant, uncontrolled heart disease and/or recent events including any of the following: * History of acute coronary syndromes (including myocardial infarction, unstable angina, uncontrolled hypertension, uncontrolled arrhythmia, stroke, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to treatment start * Cardiac history of CHF requiring treatment or Ejection fraction ≤ 50% or chronic stable angina * A cardiovascular disability status of New York Heart Association Class > 2 * Class 2 is - Defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or angina pain * On screening 12 lead electrocardiography (ECG), any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec or, Fridericia's correction formula (QTcF) > 450 msec. Congenital long QT syndrome or family history of long QT syndrome. * DLCO <=65% or FEVI <= 65\& * Treatment with any of the following within 7 days prior to the first dose of study drug: * Steroid therapy for anti-neoplastic intent * Moderate or strong cytochrome P450 3A (CYP3A) inhibitors * Moderate or strong CYP3A inducers * Medications that have a known risk to prolong the QT interval or induce Torsades de Pointes * Herbal preparations/medications * Participants receiving any medications or substances that are inhibitors or inducers of CYP2C8 enzymes are ineligible. * Administration or consumption of any of the following within 3 days prior to the first dose of study drug: * Grapefruit or grapefruit products * Seville oranges (including marmalade containing Seville oranges) * Star fruit. * Patient who has received radiotherapy =< 4 weeks prior to start of treatment or limited field radiation for palliation =< 2 weeks prior to treatment start and, who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 30% of the bone marrow was irradiated. * Patients with central nervous system (CNS) involvement. * Patients with seizure disorder. * Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) grade < =1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study). * Participant has any other concurrent severe and/or uncontrolled medical condition that would cause, in the investigator's judgment, an unacceptable safety risk. * Unwilling or unable to follow protocol requirements. * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.
21,777
Study Objectives This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms as well as functional impairment and quality of life of patients with chemotherapy induced peripheral neuropathy Conditions: Neoplasm, Adult Disease, Neuropathy Intervention / Treatment: PROCEDURE: Acupuncture, BEHAVIORAL: Orientation group Location: Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: Cancer adult patients with CIPN - Exclusion Criteria: Other neuropathy *
14,502
Study Objectives Title of study: An observational, multicenter study on the safety and efficacy of Femara® (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed adjuvant Tamoxifen or Toremifen treatment Objectives: The major objective of the study is to assess safety and efficacy of Femara® in women who had undergone resection of a primary breast cancer and subsequently received prior adjuvant tamoxifen or toremifen therapy for 5 years in real-life condition. The study aims at the following objectives: 1. To identify unknown adverse reactions, especially serious adverse reactions 2. To evaluate incidence and descriptions of adverse reactions under the routine drug use 3. To identify factors that may affect the safety of Femara® 4. To identify factors that may affect the efficacy of Femara® Methodology: This will be an open-label, multi-center, single-arm, observational phase IV study. Number of centers \& patients: Approximately 610 (planned No. of patients for total study period) patients from 4 centers will be enrolled in this study. Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment with Tamoxifen or Toremifen for 5 years after curative surgery as "indications" described in local product labeling. Investigational drug: Femara® will be administered orally as described in "dose \& administration" of local product labeling up to 3 years. Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3 years with renewal of contract on yearly basis. Conditions: Breast Cancer, Letrozole Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Written informed consent form * Postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study * Age ≥50 years with cessation of menses and Age <50 years Postmenopausal status defined by one of the following: * FSH level > 30-40 IU/L * cessation of menses over the past 1 year * are/become amenorrheic due to either chemotherapy or LHRH, are/become amenorrheic due to surgical ovarian ablation * The tumor was to be ER and/or PgR-positive or the receptor status could have been unknown * No evidence of recurrence of the disease at entry * Patient must be accessible for follow-up Exclusion Criteria: * Those patients known to have had receptor-negative primary tumors * Any concurrent malignancy * Patients who previously received hormone replacement therapy (HRT) during 5 years of adjuvant therapy with tamoxifen or toremifen * Patients who are currently receiving other aromatase inhibitors, or chemotherapy * Patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results * Life expectancy < 12 months
30,740
Study Objectives Butyrylcholinesterase (BChE) is an α-glycoprotein synthesized in the liver. BchE's serum level decreases in many clinical conditions such as acute and chronic liver damage, inflammation, injury and infections, and malnutrition. The Investigators prospectively evaluate patients undergoing elective procedures for colorectal diseases. Blood samples are collected preoperatively (at day 0), post-operatively in the recovery room (day 1), and on the subsequent four days (days 2, 3, 4, and 5) for assessment of BChE, C-reactive protein, and white blood cell concentrations. The same surgical team operates all patients and is blinded to the study. Patients are monitored for post-operative infection by using standard laboratory and clinical methods. If surgical site infection (SSI) is suspected the wound is swabbed and empirical antibiotics are started. The aim of the current trial is to study whether BChE is a reliable marker for the presence of SSI in patients undergoing colorectal surgery. Conditions: Colorectal Disorders, Colorectal Neoplasms Intervention / Treatment: COMBINATION_PRODUCT: Butyrylcholinesterase Location: Greece Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Operation for colorectal disease * Older than 18 years old Exclusion Criteria: * Younger than 18 years old
3,890
Study Objectives Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia. Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma Intervention / Treatment: BIOLOGICAL: apolizumab, OTHER: laboratory biomarker analysis, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * One of the following diagnoses: * Histologically confirmed chronic lymphocytic leukemia (CLL) or non-contiguous stage II or stage III-IV small lymphocytic lymphoma (SLL) * Previously treated with at least 1 form of chemotherapy or immunotherapy * Histologically confirmed acute lymphoblastic leukemia (enrolled after the maximum tolerated dose (MTD) is determined) * Must have failed 1 prior therapy * Ineligible for allogeneic stem cell transplantation * Histologically confirmed acute myeloid leukemia (enrolled after the MTD is determined) * Primary refractory or relapsed (within the past year) disease * Ineligible for potential curative therapy * Express Hu1D10 antigen * Greater than 2 times the mean fluorescence intensity of the control by flow cytometry (blood or bone marrow cells) OR * Positive by immunohistochemical staining (lymph node) * Presenting with one of the following indications for treatment unless early bone marrow transplantation is planned (CLL or SLL patients only): * Disease-related progressive symptoms * Progressively worsening anemia or thrombocytopenia * Progressively worsening lymphadenopathy * Massive splenomegaly or hypersplenism * Hyperlymphocytosis (WBC greater than 200,000/mm3) or lymphocyte doubling time less than 12 months * Marrow failure secondary to marrow infiltration by leukemia or lymphoma * Performance status - ECOG 0-2 * At least 2 years * See Disease Characteristics * Platelet count at least 50,000/mm\^3 (without transfusion) * Bilirubin no greater than 3 mg/dL (unless elevated secondary to tumor) * Creatinine no greater than 2.0 mg/dL * No prior decompensated congestive heart failure, unstable angina, or myocardial infarction within the past 6 months not corrected by percutaneous transluminal coronary angioplasty or surgery * No active infection requiring oral or IV antibiotics * No other malignancy that would limit life expectancy * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * See Disease Characteristics * At least 1 month since prior rituximab or alemtuzumab (unless CD20 or CD52 antigen is expressed on tumor cells) * No prior monoclonal antibody Hu1D10 * See Disease Characteristics
3,556
Study Objectives This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Cyclophosphamide, DRUG: GVAX Pancreatic Cancer Vaccine, DRUG: Pembrolizumab, RADIATION: SBRT Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Locally advanced pancreatic adenocarcinoma * Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment. * Age >18 years * No metastatic disease * ECOG Performance Status of 0 to 1 * Adequate organ function as defined by study-specified laboratory tests * Patients must be able to have fiducials placed for SBRT * Must use acceptable form of birth control through the study * Signed informed consent form * Willing and able to comply with study procedures Exclusion Criteria: * Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days * Patients who have had more than one line of chemotherapy * Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements * Patient who have had prior treatment with IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies * Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug * Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 14 days of study drug administration * Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematous (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin. * Patients who have known history of infection with HIV, hepatitis B, or hepatitis C * Patients with evidence of interstitial lung disease * Patients on home oxygen * Patients with oxygen saturation of <92% on room air by pulse oximetry * Pregnant or lactating * Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
11,394
Study Objectives The objectives of this randomized controlled trial are to compare insulin sensitivity following true acupuncture + placebo metformin (Group 1) vs sham acupuncture + placebo metformin (Group 2) vs sham acupuncture + metformin (Group 3) in women with PCOS and IR. Conditions: Polycystic Ovary Syndrome, Insulin Resistance Intervention / Treatment: OTHER: true acupuncture, OTHER: sham acupuncture, DRUG: metformin, DRUG: Placebo metformin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE
Inclusion Criteria: * Chinese women aged from 18 to 40 years. * BMI ≥18.5kg/m2. * Confirmed diagnosis of PCOS according to modified Rotterdam criteria in 2003 including at least two of the following three features: ①Oligo-(an intermenstrual interval >35 days or <8 cycles in the past year), amenorrhea (an intermenstrual interval>90 days) and/or; ② polycystic ovarian morphology, i.e. presence of >12 antral follicles (≤ 9mm) and/or ovarian volume >10 ml on transvaginal scanning and/or; ③clinical and/or biochemical hyperandrogenism. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5 ; biochemical hyperandrogenism is total testosterone (T) > 2.6 nmol/l and free testosterone ≥6.0 pg/ml. * Presence of IR as defined by the homeostatic model assessment (HOMA-IR: \[fasting insulin (μU/mL) × fasting glucose (mmol/L)\] / 22.5). A value ≥ 2.14 will be considered to be indicative of IR. * No immediate fertility wish and willingness to use barrier methods to contraception for one year. * Willingness to sign the consent form. Exclusion Criteria: * Exclusion of other endocrine disorders: ① Uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL). A normal level within the last year is adequate for entry. ② Poorly controlled of Type I or Type II diabetes (defined as a HbA1c level > 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; Patients currently receiving metformin XR (extended release) for a diagnosis of Type I or Type II diabetes or for PCOS are alsoexcluded. * Cushing's syndrome (define as an archetype of MetS. High glucocorticoid levels lead to muscle, liver and adipocyte insulin resistance. 17-OHCS>55umol/24h or UFC>304nmol/24h) ④ Congenital adrenal hyperplasia (define as patients with known 21-hydroxylase deficiency or other enzyme deficiency leading to the phenotype of congenital adrenal hyperplasia. 17-OHP>10 ng/ml in ACTH 1-24 h excited test (after 60 min)) ⑤ Suspected androgen secreting adrenal or ovarian tumor. * Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome the last 2 months. * Receiving acupuncture in the past 2 months. * Within 6 weeks pregnancy. * Post-abortion or postpartum within the past 6 weeks. * Breastfeeding within the last 4 months. * Not willing to give written consent to the study. * Having a bariatric surgery procedure within the past 12 months or being in a period of acute weight loss. * Additional exclusion criteria including: * Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins. * Heart disease ③ Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. * Patients enrolled into other studies that require medications. ⑤ Patients taking longer than a one month break during the protocol should not be enrolled.
31,551
Study Objectives The purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual disease extent in patients who have completed neoadjuvant therapy (NAT). Conditions: Breast Cancer Intervention / Treatment: DIAGNOSTIC_TEST: Breast Magnetic Resonance Imaging (MRI), DIAGNOSTIC_TEST: Contrast Enhanced Mammography (CEDM) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram * Surgery (mastectomy or BCT) planned within 60 days of the MRI Exclusion Criteria: * Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level > 1.3 or eGFR ≥45) * Known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the MRI is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy * Pregnant women * Male patients * Presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication * Known or suspected renal impairment. Requirements for GFR prior to MRI as determined by local site standard practice * Women who have already had their standard of care post-NAT mammogram and/or breast MRI
1,267
Study Objectives To evaluate the efficacy and safety of preoperative olaparib monotherapy and preoperative olaparib plus pembrolizumab combination therapy in patients with untreated stage III, IV high-grade serous or Grade 3 endometrioid ovarian cancer with Homologous Recombination Deficiency (HRD) positivity. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Olaparib, DRUG: Pembrolizumab Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Has given signed informed consent to participate in the clinical trial of her own will. * Is aged 20 years or older on the day of signing the informed consent. * Has been diagnosed with histologically confirmed, Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer by the International Federation of Gynecology and Obstetrics (FIGO) staging system (2014), with a histological type of high-grade serous or Grade 3 endometrioid carcinoma. * Have measurable disease based on RECIST 1.1. * Is a candidate for debulking surgery. * Has an HRD-positive tumor. * Has an ECOG Performance Status of 0 or 1. * Laboratory test results within 21 days prior to enrollment have met the following organ function criteria. However, measurements within 14 days of blood transfusion or administration of granulocyte-colony stimulating factor (G-CSF) are excluded. * Neutrophil count ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin ≥ 9.0 g/dL * Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min * T-Bil ≤ 2.0 mg/dL * ALT and AST ≤ 100 U/L (≤ 200 U/L if liver metastasis is present) * A woman of childbearing potential must agree to use contraception after signing the informed consent, throughout the study period, and until at least 120 days following the last dose of the study drug Exclusion Criteria: * Has received previous allogeneic bone-marrow transplantation. * Has concurrent interstitial lung disease/pneumonitis, or a history of (noninfectious) interstitial lung disease/pneumonitis that required treatment with steroids. Interstitial lung disease/pneumonitis includes radiation pneumonitis. * Has received prior antitumor therapy (e.g., chemotherapy, molecular-targeted therapy, therapeutic antibody, endocrine therapy, immunotherapy, and investigational therapy). * Has received surgery under general anesthesia within 28 days prior to enrollment. However, surgery to diagnose ovarian/fallopian tube/peritoneal cancer performed under general anesthesia is allowed. * Has received radiation or radioactive isotope therapy within 28 days prior to enrollment. * Has uncontrolled pericardial effusion, pleural effusion, or peritoneal effusion. * Has a history of cerebral infarction, cerebral hemorrhage, or transient cerebral ischemia within 180 days prior to enrollment. * Has a history of deep vein thrombosis or pulmonary embolism. * Is receiving systemic glucocorticoid therapy or systemic immunosuppressive therapy. * Has a history of autoimmune disease. * Is infected with human immunodeficiency virus (HIV). * Is infected with active\* hepatitis B or hepatitis C. \*: Active hepatitis B is defined as HBs antigen positive. * Has a symptomatic infection within 14 days prior to enrollment. * Has received a live vaccine within 28 days prior to enrollment. * Has clinically critical cardiac disease (has a history of myocardial infarction or angina pectoris within 180 days prior to enrollment or has New York Heart Association \[NYHA\] class II or higher cardiac failure, uncontrolled arrhythmia, or QTc prolongation defined as QTc > 470 msec). * Has active brain metastasis or a tumor causing spinal cord compression. * Is pregnant or breastfeeding. * Has a history of severe allergy, anaphylaxis, or hypersensitivity induced by humanized chimeric antibodies. * Is allergic to biologics produced from Chinese hamster ovary (CHO) cells, carboplatin, or paclitaxel. * Has a known or suspected active malignancy that is different from the disease of interest in the clinical trial or has a history of other malignancy within 3 years prior to enrollment. However, cutaneous basal cell carcinoma and cervical carcinoma in situ are not part of this exclusion criterion. * Is unwilling to or unable to comply with the protocol. * Is not eligible to enroll in the clinical trial based on the judgment by the Investigator or Sub-investigator.
1,899
Study Objectives Researchers at the John Wayne Cancer Institute (JWCI) at Providence Saint John's Health Center (PSJHC) are trying to examine whether acupuncture reduces joint pain in patients being treated with aromatase inhibitor (AI) therapy for breast cancer and whether the reduction in pain happens by lowering inflammation. Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: Acupuncture Therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Female * Must be on aromatase inhibitor therapy continuously for breast cancer treatment for at least the preceding two months * Must have experienced increased or new onset joint pain daily to a degree equal to or greater than 4 on a pain scale of 0-10 after starting aromatase inhibitor therapy * Able to read and write English * Able to give written informed consent to participate in the study Exclusion Criteria: * Have a known autoimmune disease or acute infection * Have had acupuncture treatment within 6 months of study enrollment * Known needle phobia * Known metal allergies * Have an implantable device, such as pacemaker, defibrillator or other device contraindicated with electrical stimulation * Use of nonsteroidal antiinflammatory drugs (NSAIDs) or narcotics within 7 days of study enrollment and during study period (15 weeks) * Receipt of prior chemotherapy, immunotherapy or radiation therapy within 90 days * On anticoagulant therapy * Receiving physical or occupational therapy concurrently * Taking herbs or herbal teas within 7 days of study enrollment and during study period (15 weeks) * Have an immune-compromising medical condition or currently receiving immune-modulating therapies (including corticosteroids) * Enrolled in any other active cancer treatment protocols * Bone fracture or surgery of an affected extremity within 6 months
35,773
Study Objectives Routine video recording of the colonoscopy examination has been proposed as a simple and easy to implement method that could improve the quality of colonoscopy. The purpose of this study is to investigate whether implementation of routine video recording of screening colonoscopy withdrawal is effective as a means of supporting quality performance of colonoscopy. The study will be performed in 8 screening centers within the framework of a national colonoscopy screening program in Poland (the Polish Colonoscopy Screening Platform; PCSP). Individuals aged 55-64 years are eligible to participate in the PCSP. In the run-in period colonoscopy quality measures will be monitored through a dedicated joint database. Then eligible screening centres will be randomly assigned in a 1:1 ratio to the video recording group or the control group. Screening centres assigned to the video recording group will receive videorecorders and DVDs and will be asked to video record all screening colonoscopies (only withdrawal). Control group will be allowed to record colonoscopies on demand only. Then , the colonoscopy quality measures will again be monitored through a dedicated joint database. All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team. Conditions: Colorectal Cancer Intervention / Treatment: PROCEDURE: Implementation of routine videorecording, BEHAVIORAL: No routine videorecording Location: Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE
Inclusion Criteria: * Screening centres participating in the Polish Colonoscopy Screening Platform (PCSP) between 2012 and 2013, in which no routine video recording of screening colonoscopies is performed * Screening centres which will sign informed consent
19,118
Study Objectives The purpose of this study is to determine if the combination of bevacizumab and pemetrexed have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at progression and survival at 6 months. Conditions: Ovarian Carcinoma, Primary Peritoneal Carcinoma Intervention / Treatment: DRUG: Pemetrexed, DRUG: Bevacizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Recurrent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the primary tumor is required. Patients with borderline tumors are not eligible. * Patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in one dimension (longest dimension to be recorded). Each lesion must by > 20 mm when measured by conventional imaging techniques, including plain radiography, computed tomography and MRI or > 10 mm when measured by spiral CT. * Patients must have at least one "target lesion" to assess response by RECIST criteria. Lesions within a previously irradiated field will be considered "non-target" lesions. * Patients must have a GOG performance status of 0 or 1. * Patients must have the ability to interrupt non-steroidal anti-inflammatory (NSAID) treatment 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed. * Patients must have the ability to take folic acid, vitamin B12 and dexamethasone as described per protocol. * Recovery from effects of recent surgery, radiotherapy or chemotherapy. * Patients should be free of active infection requiring antibiotics. * Any hormonal therapy directed at the tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy (HRT) is permitted. * Any other prior therapy directed at the malignant tumor, including immunologic agents and cytotoxic agents, must be discontinued at least three weeks prior to registration. * Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment. * Patients must have had one prior regimen containing a taxane compound. Patient may have received first-line treatment either intravenously or intraperitoneally. * Patients must NOT have received prior therapy with pemetrexed or bevacizumab. * Patients may have received a total of < 2 prior cytotoxic chemotherapy regimens (adjuvant therapy plus one additional regimen). Consolidation or extended therapy as part of first line treatment will be considered as a single regimen. * Bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTC) grade 1; Platelets greater than or equal to 100,000/ul. * Creatinine clearance must be greater than 45 ml/min. * Hepatic function: bilirubin less than or equal to 1.5 x ULN. AST and alkaline phosphatase less than or equal to 2.5 x ULN. * Neurologic function: neuropathy (sensory and motor) less than or equal to CTC grade 1. * Coagulation: prothrombin time (PT) such that the international normalized ratio (INR) is < 1.5 (INR may be between 2 and 3 if a patient is on stable dose of therapeutic warfarin) and a PTT < 1.2 times control. * Patients must have signed informed consent. * Patients must meet pre-entry requirements. * Patients of childbearing potential must have a negative serum pregnancy test prior to study entry, be practicing an effective form of contraception, and cannot be lactating. * Patients may have received prior radiotherapy (to less than 25% of bone marrow), but must start at a Level 1 dose reduction. Exclusion Criteria: * Patients with serious, non-healing wound, ulcer or bone fracture. * Patients with clinically significant cardiovascular disease: * Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) * Any prior history of hypertensive crisis or hypertensive encephalopathy. * Unstable angina within 6 months prior to study enrollment. * New York Heart Association (NYHA) grade II or greater congestive heart failure. * Serious cardiac arrhythmia requiring medication. * Grade II or greater peripheral vascular disease. Patients with claudication within 6 months. * History of myocardial infarction within 6 months. * Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels. * Patients with the presence of ascites or other third space fluid which cannot be controlled by drainage. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study or anticipation of need for major surgical procedure during the course of the study. * Patients with history or evidence upon physical examination of central nervous system disease, including primary brain tumor, brain metastases, seizure not controlled with standard medical therapy, history of cerebrovascular accident (CVA, stroke), or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study. * Minor surgical procedures, other than central venous access placement, such as fine needle aspiration or core biopsy within 7 days prior to day 1 of study. * Patients with proteinuria. At baseline patients will undergo a urine protein-creatinine ratio (UPCR) (Appendix IV). Patients with a UPCR > 1.0 at screening should be excluded. Urine dipstick for proteinuria may also be used. Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible). * Patients whose circumstances do not permit completion of the study or the required follow-up. * Patients who are pregnant or nursing. * Patients under the age of 18. * Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer within the last 5 years or whose previous cancer treatment contraindicates this protocol. * Prior therapy with anti-angiogenic agents or pemetrexed. * Patients with active infection requiring parenteral antibiotics. * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months. * Partial or complete small or large bowel obstruction demonstrated radiographically within 3 months prior to study. * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study. * Known hypersensitivity to any component of bevacizumab. * Inability to comply with study and/or follow-up procedures. * Life expectancy of less than 12 weeks.
189
Study Objectives In this study our hypothesis is that infusion of donor lymphocyte immune cells from the subject's bone marrow donor will activate the subject's immune system to attack their cancer. Conditions: Leukemia, Myeloid, Chronic, AML, MDS, Leukemia, Lymphocytic, Acute Intervention / Treatment: PROCEDURE: Donor Lymphocyte Infusion Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Patients with CML, AML, MDS or ALL relapsed after related or unrelated donor allogeneic marrow transplantation. * Patients must be within one year of identification of relapse or if beyond that time period, must have some evidence of donor DNA by RFLP or cytogenetics. * Patients may have evidence of relapse based on molecular, cytogenetic or morphologic criteria. * CML patients must have cytogenetic evidence of relapse or if Ph negative to start, obvious evidence of relapse other than minimal residual disease. * Patients must have <30% marrow blasts on a marrow biopsy performed within two weeks of the first donor lymphocyte infusion. * Patients with >30% blasts can become eligible for donor lymphocytes after reinduction with any standard therapy regimen. * Patients with AML, MDS or ALL achieving a CR with standard therapy regimens are eligible for this protocol. * Patients who relapse with their initial disease or develop a second malignancy after related or unrelated donor allogeneic marrow transplantation with other initial diagnoses (such as but not limited to CLL, lymphoma, myeloma, juvenile CML, sarcoma, breast cancer) may also be included in this protocol. Patients will be eligible with or without other adjunct chemotherapy or radiation therapy. Post-transplant lymphomas (often referred to as EBV-associated lymphomas) will be eligible for donor leukocyte infusions on this protocol. Treatment with donor leukocytes under this protocol is restricted to malignant diseases only. Graft failure or relapse of non-malignant disorders is excluded from receiving donor leukocyte infusions on this protocol. Autologous transplant patients who relapse are not eligible for this protocol. Patients with malignant diseases amenable to other curative therapy are not eligible (i.e. skin cancers). Exclusion Criteria: * Patients with concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible. * Patients with >30% marrow blasts at the time of therapy will be ineligible. * Patients on prednisone, cyclosporine, Imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of GVHD. * CML patients in complete cytogenetic remission who are bcr/abl positive by PCR only are not eligible.
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Study Objectives This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy. This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV) Conditions: Colonic Adenoma, Colonic Polyp, Colonoscopy Intervention / Treatment: DEVICE: Endocuff Vision (ECV) second generation Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Patient scheduled for total colonoscopic exploration, during the period study * Patient over or equal to 18 years * ASA 1, ASA 2, ASA 3 * No participation in another clinical study * Certificate of non opposition signed Exclusion Criteria: * Patient under 18 years old * ASA 4, ASA 5 * Pregnant woman * Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress. * Inflammatory bowel disease * Known colonic stenosis * Diverticulitis less than 6 weeks old * Patient unable to give consent or protected by law * Opposition expressed for inclusion in the study
18,431
Study Objectives This is a Phase I clinical trial evaluating crenolanib (CP-868,596), an inhibitor of Platelet Derived Growth Factor Receptor (PDGFR)-kinase in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) or in recurrent, progressive or refractory High Grade Glioma (HGG) including DIPG (Stratum B). This study drug targets the most commonly amplified region of genome found in DIPG and pediatric high grade glioma (HGG) which encodes for the PDGF receptor kinase. An oral investigational agent crenolanib will be administered daily during and after local radiation therapy (RT) in Diffuse Intrinsic Pontine Glioma DIPG (Stratum A), or daily for children with recurrent/refractory HGG (Stratum B). Conditions: Diffuse Intrinsic Pontine Glioma, Progressive or Refractory High-Grade Glioma Intervention / Treatment: DRUG: Crenolanib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Age must be ≥ 18 months and < or equal to 21 years * Body surface Area (BSA) ≥ 0.55 m\^2 * Lansky (for research participants ≤ 16 years) or Karnofsky (for research participants > 16 years) performance score ≥ 40 at the time of study enrollment * Adequate organ function at the time of study enrollment as follows: * Bone marrow: Absolute neutrophil count (ANC) ≥ 1,000/μL, platelet count ≥ 75,000/μL (transfusion independent), hemoglobin concentration ≥ 8g/dL (may be transfused) * Renal: Normal serum creatinine concentration based on age as shown below or glomerular filtration rate (GFR) > 70 ml/min/1.73m\^2 * Age (years): < or equal to 5 and the maximum serum creatinine (mg/dL) is 0.8; * 5 < age < or equal to 10 and the maximum serum creatinine (mg/dL) is 1.0; * 10< age < or equal to 15 and the maximum serum creatinine (mg/dL) is 1.2; * >15 and the maximum serum creatinine (mg/dL) is 1.5; * Hepatic: Total bilirubin concentration < or equal to 1.5 times the institutional upper limit of normal for age; SGPT < or equal to 3 times the institutional upper limit of normal * Pancreatic: Serum amylase < or equal to 3 times the institutional upper limit of normal for age; lipase < or equal to 3 times the institutional upper limit of normal * Female research participants of childbearing age must not be pregnant as confirmed by a serum or urine pregnancy test within 1 week of start of treatment. Participants must not be breast-feeding. * Males or females of reproductive potential may not participate unless they have agreed to use two effective contraceptive methods. Abstinence in a non-sexually active child will be sufficient birth control. Inclusion Criteria - Stratum A * Diagnosis of DIPG or high-grade glioma originating from the brainstem. * Patients have had no previous treatment except corticosteroid use. Inclusion Criteria - Stratum B * Patients must have radiologic evidence of recurrent, refractory or progressive high-grade glioma or DIPG. Patients must have either a diagnosis of HGG within the brain and/or spinal cord including DIPG or other high-grade glioma originating from the brainstem. A histologically confirmed diagnosis of anaplastic astrocytoma (WHO grade III), anaplastic oligodendroglioma (WHO grade III), anaplastic oligoastrocytoma (WHO grade III), anaplastic ganglioglioma (WHO grade III), pleomorphic xanthoastrocytoma with anaplastic features (WHO grade III), malignant glioneuronal tumor, glioblastoma multiforme (WHO grade IV) or gliosarcoma (WHO grade IV) is required. For patients with radiologic features of DIPG histologic confirmation of diagnosis is not required. * Patients must be able to swallow pills or take pills crushed in water based juice or puree (e.g. applesauce, apple juice) by mouth or gastric tube. * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration. * Patients who are on dexamethasone must be on a stable or decreasing dose for at least one week prior to registration. * Patients must have fully recovered from the acute toxic effects of chemotherapy, immunotherapy, or radiotherapy prior to entering this study. * Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least four weeks prior to study registration or at least six weeks if nitrosourea. At least two weeks must have lapsed if patients received lower dose oral etoposide (50 mg/2) without experiencing evidence of myelosuppression (i.e. neutropenia or requiring transfusion with blood products) * Biologic agent: Patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent ≥ 7 days prior to study registration. For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration. * Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration. Such patients should be discussed with the study chair prior to registration. * Radiation: Patient has received radiation therapy prior to study registration Patients must have had their last fraction of local irradiation to the primary tumor ≥ 3 months prior to registration and their last fraction of craniospinal irradiation (>24Gy) > or equal to 3 months prior to registration. Patient has not received focal irradiation for symptomatic metastatic sites within 2 weeks prior to registration. * Bone Marrow Transplant: Patient must be ≥ 3 months since high dose chemotherapy and peripheral blood stem cell rescue prior to registration. * Growth factors: Patients must be off all colony forming growth factors(s) for at least 1 week prior to registration (filgrastim, sargramostim, erythropoietin) and at least 2 weeks for long-acting formulations (e.g. neupogen). Exclusion Criteria: * Metastatic disease outside the CNS. * Use of enzyme-inducing anticonvulsants (EIACs) within 7 days prior to registration. * Research participants with uncontrolled infection * Research participants with any concomitant significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy, or that would impair the evaluation of side effects related to this treatment, alter drug metabolism or the tolerance to this treatment * Research participants receiving any other anticancer or investigational drug therapy * Prior therapy with crenolanib Of note, the use of any concomitant medication that may affect CYP3A function except for dexamethasone, should be discussed with the principal investigator of this study (or her designee).
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Study Objectives RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. Changes in quality of life may be related to changes in immune function and neuroendocrine function. PURPOSE: This randomized phase I trial is studying how well telephone counseling works compared to standard care in reducing stress in patients who have completed treatment for stage I, stage II, or stage III cervical cancer. Conditions: Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment Intervention / Treatment: BEHAVIORAL: Psychosocial Telephone Counseling (PTC) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE
INCLUSION CRITERIA Disease Characteristics: * Diagnosis of cervical cancer between the past 3-15 months * Stage I-III disease * Completed therapy for cervical cancer ≥ 1 month ago * Not receiving ongoing treatment * More than 4 weeks since prior immunotherapy * More than 30 days since prior investigational drugs * No prior biological response modifier * No concurrent corticosteroids * No concurrent immunosuppressive therapy Patient Characteristics: * Resident of Orange, San Diego, or Imperial County in California * English or Spanish speaking * No serious acute or chronic illness * Has access to a telephone EXCLUSION CRITERIA Disease Characteristics: * Stage IV cervical carcinoma * Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment * Used investigational drugs within 30 days of execution of the informed consent * Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection * Patients with metastatic disease or ongoing treatment * Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators Patient Characteristics: * Non-English or Spanish speakers
25,658
Study Objectives This pilot, randomized clinical trial studies a web-based tailored educational program in improving nurse communication with patients about clinical trial treatment options. A web-based tailored educational program may empower and prepare nurses to discuss clinical trial treatment options with patients and may also increase patient participation in clinical trials. Conditions: Healthy, no Evidence of Disease Intervention / Treatment: OTHER: IMPACT intervention, OTHER: Online education materials, OTHER: survey administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Currently practicing nurse * Involved in direct patient care * Self-identify in one of the following primary practice roles--case managers, clinical nurse specialists, nurse practitioners, managers/coordinators, nurse navigators, patient educators, and staff nurses * Available email address Exclusion Criteria: * Research nurses, nurses without direct patient care, and nurse managers/directors (i.e. not involved in direct patient care) * Lack of email address
27,480
Study Objectives To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma. Conditions: Sarcoma, Kaposi, HIV Infections Intervention / Treatment: DRUG: Vesnarinone Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Masking: NONE
Inclusion Criteria Concurrent Medication: Allowed: * Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria. * Acyclovir as acute treatment for herpes outbreaks. Concurrent Treatment: Allowed: * Limited electron-beam radiation therapy to non-marker lesions for treatment of Kaposi's sarcoma. Patients must have: * Documented HIV infection. * Kaposi's sarcoma. * No current constitutional signs of HIV disease or AIDS-defining conditions other than Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Active malignancy other than Kaposi's sarcoma, cutaneous basal cell carcinoma, or in situ carcinoma of the cervix. * Current significant cardiac disease or anomaly (including prolonged QTC on EKG). * Abnormal cardio-thoracic ratio on chest x-ray. Concurrent Medication: Excluded: * Antiretroviral agents, including ddI, ddC, AZT, and d4T. * Immunosuppressive agents. * Investigational HIV drugs/therapies including vaccines (except those on treatment IND for approved indications). * Other anti-Kaposi's sarcoma/HIV drugs. * Corticosteroids (other than topical). * Biologic response modifiers. * Megestrol acetate. * Agents known to cause neutropenia. * Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. * Cytotoxic chemotherapy. Concurrent Treatment: Excluded: * Radiation therapy including electron beam irradiation (other than limited electron-beam radiation to non-marker lesions for treatment of Kaposi's sarcoma). Patients with the following prior conditions are excluded: * Prior history of significant cardiac disease or anomaly. * History of agranulocytosis or severe grade 3 drug-induced neutropenia or documented abnormalities in granulocyte function. Prior Medication: Excluded: * AZT within 14 days prior to study entry. * Acyclovir as prophylaxis for herpes within 48 hours prior to study entry. Excluded within 30 days prior to study entry: * Interferon. * Biologic response modifiers. * Cytotoxic chemotherapy. Prior Treatment: Excluded within 30 days prior to study entry: * Blood or cellular blood product. Active illicit drug abuse (specifically cocaine, amyl nitrate, heroin, or other cardioactive agents).
6,396
Study Objectives This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting. Participating patients at the time of registration will have measurable relapsed or primary refractory lymphoma. Conditions: Non-Hodgkin's Lymphoma, Hodgkin's Disease Intervention / Treatment: DRUG: gemcitabine, vinorelbine Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * age 18 to 70 years * relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD) * measurable disease (clinically or radiologically) * ECOG 0 - 2 * written informed consent Exclusion criteria: * bilirubin > 50μmol/litre unless secondary to lymphoma * creatinine > 2 x upper limit of normal unless secondary to lymphoma, * absolute neutrophil count <0.5 x 109/litre and / or platelets < 50 x 109/litre unless secondary to lymphoma * isolated bone marrow disease * known sensitivity to E coli derived preparations
28,693
Study Objectives The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: PF-06804103, DRUG: PF-06804103 + Palbociclib +Letrozole Location: Spain, Australia, United States, Italy, Russian Federation, Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE
Inclusion Criteria: * HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only) * HER2 positive and negative breast cancer (Part 2A) * HER2 negative breast cancer (Part 1B \& Part 2B) * Performance status of 0 or 1 * Adequate bone marrow, kidney and liver function Exclusion Criteria: * Known CNS disease including, but not limited to, metastases * History of exposure to certain cumulative doses of anthracyclines * Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy * Active and clinically significant bacterial, fungal, or viral infection * Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA * Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases
19,769
Study Objectives The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. Since receiving FDA clearance in April 2013, the NBS has been used in nearly 300 procedures conducted at approximately 20 leading institutions across the United States. This post-market, multi-center retrospective study is designed to collect long-term follow-up data on patients who were treated previously with NBS. Conditions: Primary Brain Tumor Intervention / Treatment: PROCEDURE: NeuroBlate® System Therapy Location: United States Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Patient was previously treated with NBS * Patient is willing and able to provide informed consent and authorization for release of personal health information or IRB waiver is granted to collect study information without patient consent Exclusion Criteria: There are no exclusion criteria for this study.
17,568
Study Objectives The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Breast Cancer Clinical Trials Education Program Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: TRIPLE
Inclusion Criteria: * Self-Identified as an African American or a Hispanic American female * Speak English and/or Spanish * Mentally and Physically capable of completing the consenting process Exclusion Criteria: * None
37,819
Study Objectives The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma. Conditions: Relapse/Refractory Multiple Myeloma Intervention / Treatment: DRUG: LBH589 (panobinostat), DRUG: bortezomib, DRUG: dexamethasone Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Patient had a previous diagnosis of multiple myeloma * Patient required retreatment for multiple myeloma * Patient had measurable M component in serum or urine at study screening Exclusion Criteria: * Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy) * Patient who had been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose * Patient received prior treatment with DAC inhibitors including panobinostat * Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG
5,311
Study Objectives This randomized, pilot phase I trial studies the side effects of berberine chloride in treating patients with ulcerative colitis and who are in remission (a decrease in or disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer. Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or coming back. The use of berberine chloride may keep colorectal cancer from forming in patients with ulcerative colitis. Conditions: Ulcerative Colitis Intervention / Treatment: DRUG: Berberine Chloride, OTHER: Laboratory Biomarker Analysis, OTHER: Placebo Administration Location: United States, China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE
Inclusion Criteria: * Patients with ulcerative colitis in clinical remission (UCDAI) =< 1 for at least 3 months, regardless of how long ago they were diagnosed for UC * Receiving maintenance therapy with mesalamine for at least 3 months * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) * Leukocytes >= 3,000/microliter * Absolute neutrophil count >= 1,500/microliter * Platelets >= 100,000/microliter * Total bilirubin within normal institutional limits; higher values (=< 3 x institutional upper limit of normal \[ULN\]) are acceptable in participants with: 1. known or suspected cholangitis associated with Crohn's disease, or 2, known or suspected inborn errors of metabolism that lead to increased bilirubin * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOP\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 1.5 x institutional ULN * Creatinine within normal institutional limits * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants who have had any immunomodulatory treatment in the past 3 months will be excluded * Participants who have taken any medicines that are inducers, inhibitors or substrates of select cytochrome (CYP) isozymes within the past 3 months will be excluded; participants who have consumed either grapefruit juice or Seville orange juice in the past 7 days will be excluded * Participants with dysplasia-associated mass or lesion (DALM) due to longstanding idiopathic inflammatory bowel disease will be excluded * Participants who are currently receiving any other investigational agents or have received investigational agents within the past 3 months will be excluded * Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to berberine will be excluded * Patients with 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 in the opinion of investigators would jeopardize patient safety of data integrity are excluded; individuals who are human immunodeficiency virus (HIV) positive will not necessarily be excluded, will be considered on a case-by-case basis, but will be required to meet criteria related to patient safety and data integrity, as assessed by investigators * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with berberine; women are considered to be of child-bearing potential if they are not surgically sterile or under the age 65 and have menstruated within the last two years
2,433
Study Objectives The purpose of this study is to find out what effects carfilzomib has on relapsed multiple myeloma when administered in combination with cyclophosphamide and dexamethasone. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Carfilzomib, DRUG: Cyclophosphamide, DRUG: Dexamethasone Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Relapsed symptomatic multiple myeloma as per the International Myeloma Working group criteria \[Palumbo 2009\]. * Measurable disease, as defined by one or more of the following (assessed within 21 days prior to registration): * Serum M-protein ≥ 5 g/L (0.5g/dL) * Urine Bence-Jones protein ≥ 200 mg/24 hours * Involved serum free light chain (FLC) measurement ≥ 100 mg/L (10 mg/dL), provided serum FLC ratio is abnormal (abnormal if FLC ratio is <0.26 or >1.65) * Biopsy proven plasmacytoma * For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL) * Prior treatment with at least one, but no more than three, regimens for multiple myeloma * Documented relapse or progressive disease on or after any regimen (subjects refractory to the most recent line of therapy are eligible except those who are refractory to bortezomib and cyclophosphamide as described in exclusion criteria 1. * Achieved a response to at least one prior regimen (defined as ≥ 25% decrease in M-protein) * Age ≥ 18 years. * Life expectancy ≥ 3 months. * ECOG performance status 0-2. * Laboratory Requirements (must be done within 21 days of registration): * Hematology: * Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L * Hemoglobin ≥ 8 g/dL (80 g/L) (subjects may be receiving red blood cell (RBC) transfusions in accordance with institutional guidelines) * Platelet count ≥ 50 × 10\^9/L, independent of platelet transfusions for 7 days. (≥ 30 × 10\^9/L if myeloma involvement in the bone marrow is ≥ 50%) * Biochemistry: * ALT ≤ 3.5 x UNL * Serum direct bilirubin ≤ 2 mg/dL (34 μmol/L) (only required if total bilirubin ≥ 2mg/dL (34μmol/L) * Creatinine clearance (CrCl) ≥ 30 mL/minute (Crockcroft and Gault formula) and not on dialysis. * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. * Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. * In accordance with CRO policy, protocol treatment is to begin within 2 working days of patient registration. * Women/men of childbearing potential must have agreed to use a highly effective contraceptive method. Exclusion Criteria: * Refractory to any proteasome inhibitor therapy (bortezomib, ixazomib, etc.) Refractory disease is defined as failure to respond to the proteasome inhibitor, initial response followed by progression while on a proteasome inhibitor, or relapse within 60 days of stopping proteasome inhibitor therapy. * Prior carfilzomib treatment. * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Waldenström's macroglobulinemia or IgM myeloma * Current or previous Plasma cell leukemia defined as (> 2.0 × 10\^9/L circulating plasma cells by standard differential) * Chemotherapy or investigational agent within 3 weeks prior to registration or antibody therapy within 6 weeks prior to registration * Radiotherapy to multiple sites within 28 days prior to registration; localized radiotherapy to a single site within 7 days prior to registration * Plasmapheresisis within 14 days of registration. * Pregnant or lactating females. * Major surgery within 21 days prior to registration. * Active, uncontrolled bacterial, fungal, or viral infection. * Concurrent amyloidosis * Known human immunodeficiency virus infection. * Active hepatitis B or C infection. * Myocardial infarction within 4 months prior to registration, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker. * Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to registration. * Other malignancy, including MDS, within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason Score 6 or less with stable prostate-specific antigen levels; or cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumours of the adrenal or pancreas. * Significant neuropathy (≥ grade 3, or grade 2 with pain) within 14 days prior to registration. * Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib). * Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment. * Ongoing graft-versus-host disease. * Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to registration. * Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
769
Study Objectives This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT) antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating chemotherapy. Conditions: Neuroblastoma, Ewings Sarcoma, Osteogenic Sarcoma, Rhabdomyosarcoma, Synovial Sarcoma Intervention / Treatment: BIOLOGICAL: Autologous dendritic cell vaccine with adjuvant Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Confirmed diagnosis of relapsed high-risk neuroblastoma,Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma, synovial sarcoma * Patient may have gross tumor that has been treated with multi-agent chemotherapy prior study entry, but does not need to have gross tumor prior to study entry. * Patients must have had a diagnosis of neuroblastoma or sarcoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines. * Have received standard chemotherapy and/or SCT, and are at least 6 months post-transplant. * Age: Patients must be 1 - < 25 years of age when registered on study. * Organ Function Requirements: All patients must have adequate organ function defined as: * Hematological Function: ANC ≥ 500; Platelet count ≥ 75. * Renal Function: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR A maximum serum creatinine (mg/dL) based on age/gender as follows: 1YO M\&F = 0.6, 2-5YO M\&F = 0.8, 6-9YO M\&F = 1, 10-12YO M\&F = 1.2, 13-15YO M = 1.5, 13-15YO F = 1.4, 16+ M = 1.7, 16+ F = 1.4 * Cardiac Function: Patient must have normal cardiac function documented by Ejection fraction (> 55%) documented by echocardiogram or radionuclide MUGA evaluation OR Fractional shortening (≥ 28%) documented by echocardiogram * Liver Function: Total bilirubin ≤ 1.5 x normal for age, AND SGPT (ALT) and SGOT (AST) ≤ 3 x normal for age. * Room air pulse oximetry >94%. * Male and female sexually active patients of reproductive age who wish to participate must agree to use acceptable contraception. * Lansky performance scale > 70, ECOG < 2 (Appendix I). Exclusion Criteria: * Patient is pregnant. * Patients with a positive result for any of the following diagnostic tests: Hep B Ag, Hep B Core Ab, Hep C Ab, HIV-1 Ab, HIV-2 Ab, HTLV-1 Ab, HTLV-2 Ab, RPR. * Patient has a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis. * Patient is receiving concurrent systemic steroid therapy. * Patient has a known systemic hypersensitivity to DAC, Hiltonol, or any vaccine component.
1,685
Study Objectives This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel before surgery may be an effective treatment for breast cancer Conditions: Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, Progesterone Receptor-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer Intervention / Treatment: DRUG: doxorubicin hydrochloride, DRUG: cyclophosphamide, DRUG: paclitaxel, BIOLOGICAL: filgrastim, DRUG: capecitabine, DRUG: methotrexate, DRUG: vinorelbine tartrate, PROCEDURE: needle biopsy, PROCEDURE: therapeutic conventional surgery, OTHER: immunohistochemistry staining method, BIOLOGICAL: trastuzumab, DRUG: tamoxifen citrate, DRUG: letrozole, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Have known tumor HER-2/neu expression; if determination is "intermediate" by immunohistochemistry, fluorescent in situ hybridization (FISH) must be performed; protocol therapy is determined by HER-2/neu result * Have histologically confirmed, operable breast cancer that is either: * Hormone receptor (estrogen receptor \[ER\] or progesterone receptor \[PR\]) positive and HER2/neu positive or * ER/PR negative * Have radiographically measurable breast cancer > 1cm (Operable lesions are T1c-T3 and N0-N2a; histologic confirmation should be by core needle biopsy only) * Be chemotherapy naïve * Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 * Absolute neutrophil count (ANC) >= 1,500 * Platelet count >= 100,000 * Serum creatinine =< 1.5 x international upper limit of normal (IULN) * Bilirubin < 2.0 * Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) =< 2 x IULN * Alkaline phosphatase =< 2 x IULN * Have staging studies and tumor assessment prior to registration; staging studies include physical exam with bidimensional tumor measurements and mammography, ultrasound, or magnetic resonance imaging (MRI) to assess tumor volume; sentinel lymph node dissection or axillary needle biopsy must be completed prior to enrollment; MRI and positron emission tomography (PET) (fluorodeoxyglucose \[FDG\], methoxyisobutylisonitrile \[MIBI\] and fluoroestradiol \[FES\]) imaging will be done before enrollment if clinically indicated to assess tumor volume or may be done within the first month of study participation on another institutional protocol * Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or multi gated acquisition scan (MUGA) prior to enrollment; patients with breast cancer that is HER-2/neu positive who will receive herceptin (trastuzumab) must have an echocardiogram or MUGA scan; the left ventricular ejection fraction (LVEF) must be within the institutional normal range; if LVEF is > 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration * Women of childbearing potential must have a negative pregnancy test within seven days prior to registration * Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures Exclusion Criteria: * Primary tumor =< 1 cm, not measurable; inflammatory disease * Pregnant or lactating; woman of childbearing potential with either a positive or no pregnancy test at baseline are excluded; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; patients must agree to continue contraception for 30 days from the date of the last study drug administration; woman of childbearing potential not using a reliable and appropriate contraceptive method are excluded * Evidence of distant metastatic disease * Prior chemotherapy or hormonal therapy for breast cancer * Except for the following no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years * Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil * Previous enrollment in an investigational drug study within the past four weeks * History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance with oral drug intake * Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible * Active cardiac disease: * Angina pectoris that requires the use of antianginal medication * Cardiac arrhythmia requiring medication * Severe conduction abnormality * Clinically significant valvular disease * Cardiomegaly on chest x-ray * Ventricular hypertrophy on electrocardiogram (EKG) * Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic > 200 mm/hg) * Current use of digitalis or beta blockers for congestive heart failure (CHF) * Clinically significant pericardial effusion * History of cardiac disease: * Myocardial infarction documented as a clinical diagnosis or by EKG or any other test * Documented congestive heart failure * Documented cardiomyopathy * Documented arrhythmia or cardiac valvular disease that requires medication or is medically significant * Major surgery within 4 weeks of the start of study treatment without complete recovery * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome * Known, existing uncontrolled coagulopathy * Unwillingness to give written informed consent * Unwillingness to participate or inability to comply with the protocol for the duration of the study
16,023
Study Objectives This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial. Conditions: Lung Cancer, Endobronchial Dysplasia Intervention / Treatment: PROCEDURE: fluorescence bronchoscopy, PROCEDURE: quantitative high resolution CT scan, DRUG: PIOGLITAZONE VS. PLACEBO 30 mg Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE
Inclusion Criteria: * Current or former smoker (at least 10 pack years); * One or more of the following: * Mild or worse sputum atypia * Airflow Limitation (FEV1/FVC<70% predicted) * Biopsy proven airway dysplasia Exclusion Criteria: * myocardial infarction (MI) with ejection fraction < 50%; * severe/unstable angina; * history of coronary or peripheral arterial bypass grafting; * New York Heart Association (NYHA) class III or IV congestive heart failure; * hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy; * life expectancy < 6 months; history of bladder cancer * pregnant or breast feeding; inability to give informed consent
21,962
Study Objectives AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without food and without any rest periods, as long as there is no evidence of disease progression or unacceptably severe adverse events (AEs) related to the study drug. Conditions: Solid Tumors Intervention / Treatment: DRUG: Compound AC220 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Males and females age ≥18 years * Understand and voluntarily sign the informed consent form for this study * Available for periodic follow-up at the investigative site * Able to swallow the liquid study drug * ECOG performance status of 0 - 2 * Histological diagnosis of a primary solid tumor malignancy that meets the following criteria: * Evidence (radiographic or tissue confirmation) that the disease is metastatic (locally advanced disease is allowable only if no surgical or local therapeutic option exists); and * Disease which has progressed on or following currently available standard therapies or for which no curative therapy exists (Prior adjuvant, neoadjuvant, and investigational therapies are permitted.) * Measurable disease by computer tomography (CT) or magnetic resonance imaging (MRI) scans per RECIST. * Prior anticancer therapy, radiotherapy, hormonal, and immunotherapy are allowed. Patients must have recovered from toxicity of prior therapy (ie, toxicity has resolved to Grade 1, or to pre-treatment baseline, or is deemed irreversible). At least 4 weeks must have elapsed since the last systemic therapy (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy, or radiotherapy and the beginning of study drug administration. For participants with GIST on approved tyrosine kinase inhibitors (TKI), at least 2 weeks must have elapsed since the last dose of TKI. * Adequate bone marrow function, defined as: * Absolute neutrophil count (ANC) (neutrophils and bands) ≥1.5 x 10\^9 cells/L * Platelet count ≥ 100 x 10\^9 cells/L * Hemoglobin ≥ 9.0 g/dL * Adequate hepatic function, defined as: * Total serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN * Adequate renal function, defined as: * Serum creatinine ≤ 1.5 x the institutional ULN * Prothrombin time or partial thromboplastin time (PT- PTT) ≤ 1.5 x the ULN * Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits, and every effort should be made to keep potassium concentrations above 4.0 mEq/dL, magnesium concentrations above 1.8 mg/dL, and serum calcium at normal concentration with the administration of oral/IV potassium and/or magnesium and/or calcium replacement during the study. If this is not possible, potassium and magnesium (and calcium) concentrations should at least be kept within institutional normal limits. * Fully recovered (≤ Grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug administration. * Baseline left ventricular ejection fraction (LVEF) ≥ 45% (or ≥ institutional lower limit of normal if institutional lower limit of normal is below 45%) as assessed by 2-dimensional ECHO or MUGA as per institutional practice. If repeat LVEF assessment is required, the same modality should be used throughout the duration of study, whenever possible. * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study in such a manner that the risk of pregnancy is minimized. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not post menopausal (defined as amenorrhea > 12 consecutive months; or who is on hormone replacement therapy \[HRT\] with documented serum follicle stimulating hormone \[FSH\] level > 35 mIU/mL). Additionally, premenopausal women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, are practicing abstinence, or whose partner is sterile (eg, vasectomy), should be considered to be of childbearing potential. * WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[hCG\]) within 72 hours prior to the start of study drug. Exclusion Criteria: * WOCBP who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy for the entire study period and for at least 3 months after the study. * Women who are pregnant or breastfeeding * WOCBP with a positive pregnancy test on enrollment prior to study drug administration * Men who are unwilling or unable to use an acceptable method of birth control if their sexual partners are WOCBP for the entire study period and for at least 3 months after completion of the study * Patients with known untreated, symptomatic or uncontrolled brain or central nervous system (CNS) metastases. Patients with treated brain or CNS metastases that are radiographically stable for 3 months or longer are eligible. * A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive study drug * Uncontrolled or significant cardiovascular disease, including: * A myocardial infarction within 12 months prior to study entry * Uncontrolled angina within 6 months prior to study entry * Congestive heart failure (CHF) New York Heart Association (NYHA) class 3 or 4, or patients with history CHF NYHA class 3 or 4 in the past, unless the screening ECHO or MUGA within 14 days prior to study entry results in a LVEF that is ≥ 45% (or ≥institutional lower limit of normal) * Diagnosed or suspected congenital long QT syndrome * Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes \[TdP\]) * Prolonged QTc interval on pre-entry ECG (≥ 450 ms) * Any history of second or third degree heart block * Uncontrolled hypertension * Obligate need for a cardiac pacemaker * Complete left bundle branch block * Atrial fibrillation * Known infection with human immunodeficiency virus (HIV) * Known active hepatitis A, B, or C or other active liver disease * Dementia or altered mental status that would prohibit the understanding or rendering of informed consent * Investigational agents during or within 4 weeks prior to the start of study drug * Use of drugs that are generally accepted to have a risk of causing prolonged QTc and/or TdP and/or are CYP3A4 inhibitors. Patients who have discontinued any of these medications must have a washout period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of study drug and should not be allowed to take these medications during the study drug dosing. * Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator or Sponsor, could jeopardize patient safety or interfere with the objectives of the study.
37,194
Study Objectives Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553). Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT mutations. Conditions: Metastatic Melanoma With KIT Aberration Intervention / Treatment: DRUG: Nilotinib Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease * Documented KIT aberration * Adequate organ function as defined by the following criteria: * Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy * Total serum bilirubin ≤ 1.5 x ULN * Absolute neutrophil count (ANC) ≥ 1500/µL * Platelets ≥ 100,000/µL * Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated) * Serum calcium ≤ 12.0 mg/dL * Serum creatinine ≤ 1.5 x ULN * Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks * May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy * At least one measurable lesion by RECIST criteria * ECOG PS 0-2 Exclusion Criteria: * Major surgery or radiation therapy within 4 weeks of starting the study treatment. * History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan. * Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2. * QTc > 470 msec on baseline EKG. * Pregnancy or breastfeeding.
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Study Objectives The purpose of this study is to test the effectiveness of a drug called erlotinib in treating the tumor. This is a multi-center pilot study that explores efficacy and molecular effects of high dose weekly erlotinib for recurrent EGFR vIII mutant malignant gliomas, and correlate molecular profile of pre-treatment tissue with outcome. Conditions: Brain Cancer Intervention / Treatment: DRUG: erlotinib, PROCEDURE: Cytoreductive Surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE
Inclusion Criteria: * Histologically confirmed intracranial malignant glioma of the following types: Glioblastoma (GBM), Gliosarcoma (GS), Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO), Anaplastic oligoastrocytoma (AOA, also called anaplastic mixed gliomas or AMG), High grade glioma not otherwise specified (NOS). * EGFRvIII mutation detected on pretreatment tissue from at least 1 prior surgery. * At least 15 unstained slides or at least 1 tissue blocks must be collected from at least one prior surgery. * Recovered from toxic effects of prior therapies. * Able to undergo contrast enhanced MRI scans (or CT scans for patients unable to tolerate MRI). * Shown unequivocal evidence for contrast enhancing tumor progression by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan. * Age > or = 18 years. * Karnofsky Performance Status > or = 60%. * Life expectancy of > 8 weeks. * Normal organ and marrow function, adequate liver function and adequate renal function before starting therapy. * Women of child-bearing potential and men must agree to use adequate contraception. * Women of childbearing potential must have a negative pregnancy test documented within 7 days prior to treatment. * Women must agree not to breast feed. * Ability to understand and the willingness to sign a written informed consent document. * Ability to swallow the tablets. Cohort A (medical) specific inclusion criteria: * Fulfill all of the general inclusion criteria. * MRI/CT must demonstrate measurable enhancing tumor of at least 1cm2 in cross-sectional area to allow assessment of radiographic response, unless: measurable disease is not present because the patient underwent gross total resection as the most recent anti-tumor therapy. * At least 3 months have elapsed between any prior brain radiotherapy and initiation of study therapy. * MRI/CT must demonstrate measureable enhancing tumor at least 1cm by 1cm squared in cross-sectional area to allow assessment of radiographic response. * Stable or decreasing dose of corticosteroids for a minimum of 5 days before the baseline MRI/CT. * The baseline MRI/CT must be performed on the 14th day or less prior to initiation of study treatment. Cohort B (surgical) specific inclusion criteria: * Fulfill all of the general inclusion criteria. * An MRI/CT scan showing progression is required. Exclusion Criteria: * Received prior treatment with convection enhanced delivery, other catheter based intratumoral treatment, or carmustine (BCNU)/Gliadel wafers. * Prior therapy that included stereotactic radiosurgery during therapy for newly diagnosed or recurrent disease, or re-irradiation of any type, must have confirmation of true progressive disease rather than radiation necrosis based upon surgical documentation of recurrent/progressive disease. * Prior treatment with an EGFR inhibitor. * Received prior treatment with direct Vascular endothelial growth factor (VEGF)/Vascular Endothelial Growth Factor Receptors (VEGFR) inhibitors. * Smoking or plan to smoke tobacco or marijuana during study therapy. * Receiving any other investigational agents concurrently with study treatment. * Taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib. * Uncontrolled intercurrent illness that would limit compliance with study requirements. * Have HIV and are receiving combination antiretroviral therapy. * Other active concurrent malignancy.
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Study Objectives The purpose of the MycarinGstudy is to evaluate the long-term safety, tolerability and long-term efficacy of rozanolixizumab in study participants with generalized myasthenia gravis (MG). Conditions: Generalized Myasthenia Gravis Intervention / Treatment: DRUG: Rozanolixizumab Location: Czechia, Spain, United States, Japan, Italy, Germany, Denmark, France, Russian Federation, Canada, Poland, Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Participant was eligible for MG0003 \[NCT03971422\] or MGC003 at the time of enrollment into either study and the participant either completed the observation Period of MG0003 or MGC003 or required rescue therapy during the Observation Period of the lead-in studies * Body weight ≥35 kg at Visit 1 * Study participants may be male or female Exclusion Criteria: * Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, if applicable, chest X-rays (posterior anterior and lateral), and TB testing by a positive (not indeterminate) QuantiFERON®-TB Gold Plus * Participant has received a live vaccination within 8 weeks prior to the Baseline visit; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of study medication * Study participant has experienced hypersensitivity reaction after exposure to other anti-neonatal Fc receptor (FcRn) drugs - Study participant with severe (defined as Grade 3 on the myasthenia gravis-activates of daily living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis * Participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at randomization, and could jeopardize or compromise the study participant's ability to participate in this study * Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria MG0003 \[NCT03971422\] or MGC003, or discontinued study medication in either study, with the exception of discontinuation due to a need for rescue treatment * Study participant is not considered capable of adhering to the protocol visit schedule, or medication intake according to the judgment of the Investigator * Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or had suicidal ideation since the last visit in MG0003 as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
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Study Objectives The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists. Conditions: Pneumothorax, Pulmonary Nodule, Solitary, Atelectasis, Subcutaneous Emphysema, Cardiomegaly, Consolidation, Pleural Effusion Intervention / Treatment: DEVICE: Carebot AI CXR Location: Czechia Study Design and Phases Study Type: OBSERVATIONAL
Inclusion Criteria: * Hospital patients > 18 years who were referred for chest radiography October 18th, 2022, and November 17th, 2022 at the Radiodiagnostic Department of the Havířov Hospital, p.o. Exclusion Criteria: * Patients < 18 years * Chest X-ray images in lateral positions * Duplicated chest X-ray images
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Study Objectives This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in Asian patients with advanced renal cell carcinoma. The trial is only being conducted in Japan, Korea, and China. Conditions: Advanced Renal Cell Carcinoma Intervention / Treatment: DRUG: Temsirolimus (CCI-779), DRUG: Temsirolimus (CCI-779) Location: Japan, Korea, Republic of, China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: * Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC. The American Joint Committee on Cancer (AJCC) staging and classification criteria will be used. * ECOG performance status of 0-1. * At least one measurable lesion per RECIST. * Age greater than or equal to 20 years. * Japanese, Chinese, or Korean ethnicity. Exclusion Criteria: * CNS metastases at screening or history or CNS metastases. * Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for the treatment of RCC within 4 weeks before first dose of test article. Subjects must have documented objective progressive disease after any prior systemic RCC treatment and have recovered to grade 1 or lower toxicities from effects of prior systemic therapy for RCC. * In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ).
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Study Objectives Proper staging of Lung cancer is of paramount concern when determining a treatment regime. Currently the assessment of surgical candidacy is performed with the staging process, mainly the mediastinoscopy. A mediastinoscopy has the ability to access samples of the paratracheal lymph node stations (Levels 2R, 2L, 3, 4R, 4L), as well as the anterior subcarinal lymph node station (Level 7). In comparison, the EBUS-TBNA technique is a real-time procedure that has the potential to access the same paratracheal and subcarinal lymph node stations associated with the mediastinoscopy, but also extending out to the hilar lymph nodes (Levels 10 and 11). Because of the possibility of extended sampling range and a reduction in procedural invasiveness, EBUS-TBNA may represent a more efficient patient centered alternative to mediastinoscopy in the staging of lung cancer patients. Additionally, patients who are have lymph nodes in the N2 region frequently undergo chemotherapy and/or radiotherapy prior to surgery. Assessment of the lymph nodes after chemo/radiation is done using CT scans, as re-mediastinoscopy is a technically difficult procedure. These patients may benefit from EBUS-TBNA. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: PROCEDURE: Endobronchial Ultrasound Guided Transthoracic Needle Biopsy Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE
Inclusion Criteria: A) Age 18 years or older B) Patients with confirmed or suspected non-small cell lung cancer who require a mediastinoscopy as part of their staging investigations of the mediastinum to determine suitability for lung cancer resection will be considered for the trial. C) Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required. Exclusion Criteria: A) Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy or a mediastinoscopy or who are not suitable for definitive surgical resection by thoracotomy will be excluded. B) Patients who have verified stage IV disease or who are not appropriate for lung cancer resection by virtue of direct invasion of mediastinal structures or large parts of the chest wall. C) Known small cell lung cancer. D) Patients where there is a high clinical suspicion of lymphoma. E) Inability to give informed consent.
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