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{ "NCT_ID" : "NCT01025778", "Brief_Title" : "Haploidentical Stem Cell Transplantation for Children With Therapy Resistant Leukemia", "Official_title" : "Clofarabine Based Remission Induction Followed by Haploidentical Stem Cell Transplantation in Children With Refractory Hematological Malignancies", "Conditions" : ["Acute Lymphoblastic Leukemia", "Acute Myeloid Leukemia"], "Interventions" : ["Drug: Thiotepa in conditioning before transplantation", "Drug: Etoposide for remission induction", "Drug: Cyclophosphamide for remission induction", "Drug: Clofarabine in conditioning before transplantation", "Procedure: Haploidentical transplantation of T-cell depleted graft", "Drug: Melfalan in conditioning before transplantation", "Drug: Clofarabine for remission induction", "Procedure: Donor lymphocyte infusion"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Despite substantial progress in the treatment pediatric acute leukemia a significant number of children will experience primary or secondary resistance to the treatment. In other words it will be not possible to achieve remission using standard chemotherapy (primary resistance) or the patients will develop chemotherapy resistant relapse (secondary resistance). Children failing to achieve remission or children relapsing after previous allogeneic stem cell transplantation have short life expectancy and palliative treatment still remains the most reasonable option as the escalation of conventional chemotherapy is not longer effective. The role of Graft versus Leukemia effect was postulated as one of the mechanisms contributing to the leukemia control/eradication after transplantation of hematopoietic stem cells. In this study the investigators combine intensified multiagent Clofarabine containing chemotherapy with post-induction treatment intensification using reduced intensity conditioning followed by haploidentical hematopoietic stem cell transplantation. Introducing a new drug to the treatment of resistant leukemia the investigators want to achieve a response which allows us to proceed to immediate haploidentical transplantation. Using a haploidentical donor the investigators can avoid time consuming search for an unrelated donor and perform the transplantation at the optimal time-point. Combating therapy resistant leukemia the investigators would like to evoke and utilize potential Graft-versus-Leukemia effect which is much more pronounced in the haploidentical setting, as it is well documented that allogeneic transplantation with a matched donor is not effective in resistant disease. The use of best KIR mismatch donor and post-transplant donor lymphocyte infusion will be implemented in order to develop/intensify graft versus leukemia effect. #Intervention - DRUG : Clofarabine for remission induction - DRUG : Etoposide for remission induction - DRUG : Cyclophosphamide for remission induction - DRUG : Clofarabine in conditioning before transplantation - DRUG : Thiotepa in conditioning before transplantation - DRUG : Melfalan in conditioning before transplantation - PROCEDURE : Haploidentical transplantation of T-cell depleted graft - PROCEDURE : Donor lymphocyte infusion

#Eligibility Criteria: Inclusion Criteria: Target population * Refractory acute lymphoblastic leukemia * Chemoresistant isolated or combined bone marrow relapse * Relapse after during/after conventional treatment * Relapse >=6 months after allogeneic stem cell transplantation * Primary induction failure * Isolated extramedullary relapse after previous HSCT (>6 months) * Refractory acute myeloblastic leukemia including sAML * Chemoresistant relapse * Relapse after during/after conventional treatment * Relapse >=6 months after allogeneic stem cell transplantation * Primary induction failure Inclusion criteria to start induction treatment with multidrug regimen * Age >= 1 and <=21 years * Patients with previous HCST >= 6 m * Provide signed written informed consent patients', and patients' parents /guardians * Older children should be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent as well. * Cardiac output SF >=25% * Have adequate renal and hepatic functions as indicated by the following laboratory values: * Calculated creatinine clearance >=90 ml/min/1.73 m2 * Serum bilirubin <=1.5 X upper limit of normal (ULN) * Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 X ULN * Alkaline phosphatase <= 2.5 X ULN * Performance score of >=70% (Lansky or Karnofsky) * A suitable haploidentical family member available for stem cell donation, > 18 years, fulfilling institutional criteria for blood and marrow donation. * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Inclusion criteria to proceed to transplant after induction * Cardiac output SF >=25% * Have adequate renal and hepatic functions as indicated by the following laboratory values: * Calculated creatinine clearance >=90 ml/min/1.73 m2 * Serum bilirubin <=1.5 X upper limit of normal (ULN) * Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 X ULN * Alkaline phosphatase <= 2.5 X ULN * Performance score of >=70% (Lansky or Karnofsky) * A suitable haploidentical family member available for stem cell donation, > 18 years, fulfilling institutional criteria for blood and marrow donation. * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. * Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Exclusion Criteria: * Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol. * Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy. * Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment. * Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). * Pregnant or lactating patients. * Any significant concurrent malignant disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results. Sex : ALL Ages : - Minimum Age : 1 Year - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT01025778

{ "NCT_ID" : "NCT01718691", "Brief_Title" : "Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma", "Official_title" : "Phase II Clinical Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B-cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma (Multicenter, Open-label).", "Conditions" : ["Low-grade B Cell Non-Hodgkin's Lymphoma", "Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated"], "Interventions" : ["Drug: SyB L-0501", "Drug: rituximab"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma where hematopoietic stem cell transplantation is not indicated. #Intervention - DRUG : SyB L-0501 - A dose of 90 mg/m\^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. - DRUG : rituximab - A dose of 375 mg/m\^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.

#Eligibility Criteria: Inclusion Criteria: * Patients who are histopathologically confirmed to have the following cluster of differentiation 20 (CD20) positive low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma by lymph node biopsy or evaluable tissue biopsy within 6 months before the registration WHO Classification of Tumors (fourth edition): * Small lymphocytic lymphoma * Splenic marginal zone B-cell lymphoma * Lymphoplasmacytic lymphoma * Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) * Nodal marginal zone B-cell lymphoma * Follicular lymphoma (Grade 1, 2, 3a) * Mantle cell lymphoma * Patients with a measurable lesion ( > 1.5 cm in major axis on CT) * Patients without a medical history * Patients with at least 1 of the following clinical symptoms or signs (excluding mantle cell lymphoma): * Bulky disease measuring > 7 cm in major axis on CT (excluding spleen) * B symptoms 1. Fever exceeding 38.0ºC of unknown cause 2. Night sweats 3. Weight decrease exceeding 10% within 6 months before patient registration * Elevated serum LDH or beta 2 microglobulin * Three or more regional lymph nodes of > 3 cm in major axis on CT * Symptomatic splenomegaly * Intracranial pressure * Pleural effusion/ascites retention * Patients expected to live for at least 3 months * Patients aged between 20 and 79 years (at the time of registration) * Patients whose Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) is 0～2 * Patients with adequately maintained major organ function (bone marrow, heart, lungs, liver, kidneys) * Neutrophil count: not less than 1,500 /mm3 * Platelet count: not less than 75,000 /mm3 * Aspartate aminotransferase (AST)[Glutamic oxaloacetic transaminase (GOT)]: not more than 3 times the standard upper limit for the site * Alanine aminotransferase (ALT)[Glutamic pyruvic transaminase (GPT)]: not more than 3 times the standard upper limit for the site * Total bilirubin: not more than 1.5 times the standard upper limit for the site * Serum creatinine: not more than 1.5 times the standard upper limit for the site * Arterial partial pressure of oxygen (PaO2): not less than 65 mmHg * Electrocardiogram shows no abnormal findings that require treatment * Echocardiogram of left ventricular ejection fraction (LVEF): not less than 55% * Patients whose informed consent has been obtained in person Exclusion Criteria: Patients who fall under any one of the following criteria are to be excluded * Patients whose transformation has been confirmed histopathologically * Mantle cell lymphoma patients aged 65 years or younger * Patients who were administered or received transfusion of cytokine formulations such as G-CSF (granulocyte colony stimulating factor) and erythropoietin within 14 days before pre-registration test * Patients with severe active infectious disorders (receiving antibiotics, antifungals, or antivirus IV injection) * Patients with serious complications (such as hepatic or renal failure) * Patients with severe complications of cardiac disease (examples: myocardial infarction, ischemic heart disease) or its previous history within 2 years before patient registration, and patients with arrhythmia requiring a treatment * Patients with serious gastrointestinal conditions (persistent or severe nausea/vomiting or diarrhea) * Patients who are positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody or HIV antibody [if HBs or hepatitis B core (HBc) positive, patients whose hepatitis B virus (HBV)-DNA test results indicate positive] * Patients with serious bleeding tendencies [such as disseminated intravascular coagulation (DIC)] * Patients having or suspected of having symptoms indicative of the central nervous system (CNS) involvement * Patients with interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema complications requiring treatment or its medical history. * Patients with active multiple primary cancer * Patients who received chemotherapy, radiotherapy, antibody therapy and antitumor steroid therapy in the past * Patients with complications or medical history of autoimmune haemolytic anaemia * Patients who were administered investigative or unapproved drugs within 3 months before patient registration * Patients with addiction to drugs or narcotics, or alcoholism * Patients who have previously received hematopoietic stem cell transplantation * Patients who are or may be pregnant, lactating patients * Patients, whether male or female, who do not agree to use contraception * Patients otherwise judged by the investigator or the sub-investigator to be unsuitable for inclusion in the study Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01718691

{ "NCT_ID" : "NCT01317940", "Brief_Title" : "Nutrition and Body Composition in Acute Lymphoblastic Leukemia", "Official_title" : "Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)", "Conditions" : ["Precursor Cell Lymphoblastic Leukemia-Lymphoma", "Vitamin D Deficiency"], "Interventions" : ["Dietary Supplement: Vitamin D and Calcium Citrate"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue. In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called qCT (quantitative computed tomography) while body composition and body fat will be measured by a different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study will also examine in depth the relationship between these three elements - Vitamin D insufficiency, obesity, and ALL - and their impact on bone density. #Intervention - DIETARY_SUPPLEMENT : Vitamin D and Calcium Citrate - Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day for approximately 6-7 months - Other Names : - 1,25-Dihydroxycholecalciferol, Calcitriol, Rocaltrol (Roche), Calcium carbonate

#Eligibility Criteria: Inclusion Criteria: GROUP A: Patients with newly diagnosed ALL * Are greater than or equal to 10 years and less than or equal to 21 years at diagnosis of ALL * Have a new diagnosis of untreated ALL classified as 'high risk' per NCI criteria (due to being greater than 10 years) * Are beginning treatment with a Children's Cancer Group/Children's Oncology Group 'high risk' protocol with a 4-drug induction including steroids * Are not pregnant GROUP B: Early survivors of ALL * Were treated for ALL and remain in first CR1 (complete remission) * Were equal to or greater than 10 years and less than or equal to 21 years at diagnosis of ALL * Have completed treatment on or as per a Children's Cancer Group/Children's Oncology Group 'high risk' protocol between 12 and 48 months prior to enrollment in this study (consisting of a plan for a 4-drug induction including steroids in Induction, Delayed Intensification, and steroid pulses in Maintenance. Steroids are allowed to have been discontinued due to toxicity). * Are not pregnant GROUP C: Siblings of Group A * Are either a full-sibling or a half-sibling of a patient in Group A * Are living at the same residence as the sibling/half-sibling from Group A * Are greater than or equal to 10 years and less than or equal to 21 years at the time of study entry, and within 3 years of the age diagnosis of ALL in the sibling/half-sibling from Group A * Are on the same Vitamin D supplementation regimen (if any) as the sibling from Group A at the time of his or her diagnosis Exclusion Criteria (All Groups): * Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal bone development * Are undergoing treatment with other medicines that affect bones including chronic use of of steroids, bisphosphonate therapy, or Vitamin D at average dose greater than 400 international units (IU)/day * Have an underlying diseases altering body structure (i.e. missing a limb, severe dysmorphism) or severely affecting mobility (i.e. total or hemiparesis) * Have a history of chemotherapy or radiation for other cancers * Cannot complete the radiology exams/radiology exams uninterpretable (i.e. people with a hip replacement or prosthesis) Sex : ALL Ages : - Minimum Age : 10 Years - Maximum Age : 29 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT01317940

{ "NCT_ID" : "NCT00928798", "Brief_Title" : "Topical Rapamycin for Fibrofolliculomas", "Official_title" : "Topical Rapamycin to Treat Fibrofolliculomas in Birt-Hogg-Dubé Syndrome", "Conditions" : ["Birt-Hogg-Dubé Syndrome"], "Interventions" : ["Drug: placebo", "Drug: Rapamycin"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of the study is to determine whether topical application of rapamycin can lead to reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the growth of new ones. Secondary we evaluate rapamycin safety, formula acceptance and patient satisfaction. #Intervention - DRUG : Rapamycin - Application of rapamycin 1 mg/ml oral solution to one predefined skin area on one facial half, twice daily 0,25 ml, during 6 months. The other facial half will be similarly treated with a placebo. - Other Names : - Rapamune, Sirolimus - DRUG : placebo - Application of placebo to one predefined skin area on one facial half, during 6 months. The other facial half will be similarly treated with rapamycin 1 mg/ml oral solution

#Eligibility Criteria: Inclusion Criteria: * Minimum age of 18 years. * At least 10 facial fibrofolliculomas, histologically confirmed. * Entered in a screening program and free of malignancy as determined during screening (already had a baseline MRI or CT-scan). * Being able to understand instructions. * Mutation status must be known. * For females: not pregnant and willing to use both oral and barrier contraceptives during the treatment period. Exclusion Criteria: * Not capable of informed consent. * Age under 18 years. * Pregnancy or failure to comply with contraceptive measures. * Proven or suspected malignancy of skin or other organs. * No histological confirmation. * Skin lesions other than fibrofolliculoma that might worsen under sirolimus such as active infections. * Not able to comprehend instructions. * No proven mutation. * Less than 10 fibrofolliculomas. * Planned facial surgery in the treatment period. * Concomitant disease requiring systemic immunosuppressive treatment * Concomitant disease requiring facial topical immunosuppressive treatment or facial topical drugs that interfere with rapamycin during trail period or in the 30 days before start trial. * Tendency to form keloids or hypertrophic scars. * Drug or alcohol abuse. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00928798

{ "NCT_ID" : "NCT00866918", "Brief_Title" : "Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia", "Official_title" : "Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation", "Conditions" : ["Childhood Acute Promyelocytic Leukemia With PML-RARA", "Myeloid Neoplasm"], "Interventions" : ["Drug: Mercaptopurine", "Drug: Methotrexate", "Drug: Idarubicin", "Drug: Cytarabine", "Drug: Mitoxantrone Hydrochloride", "Drug: Arsenic Trioxide", "Other: Diagnostic Laboratory Biomarker Analysis", "Drug: Tretinoin"], "Location_Countries" : ["Puerto Rico", "Canada", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Detailed Description PRIMARY OBJECTIVES: I. To decrease the total anthracycline dose from the best current published results in standard risk childhood acute promyelocytic leukemia (APL) while still maintaining a comparable event-free survival (EFS). SECONDARY OBJECTIVES: I. To assign treatment based on risk stratification by white blood cell count (WBC) at diagnosis. II. To estimate the induction failure rate, toxic death rate, disease-free survival rate and overall survival rate in both standard and high risk APL patients. III. To monitor for cardiotoxicity in an idarubicin/mitoxantrone based regimen. IV. To document the toxicity of a traditional chemotherapy/all-trans retinoic acid (ATRA) (tretinoin) based regimen combined with arsenic trioxide therapy. V. To study the relationship of Fms-like tyrosine kinase 3 (FLT3) mutations to clinical features and outcome in APL. VI. To study risk factors for pseudotumor cerebri in APL. VII. To study the relationship of early progenitor cell involvement to treatment failure in FLT3 positive APL. VIII. To compare the EFS of children enrolled on AAML0631 with the EFS of children enrolled on C9710 who were between the ages of 2 and 21 and did not receive arsenic trioxide. IX. To estimate the proportion of patients who carry a cryptic t(15;17), i.e., those who are positive for a promyelocytes.(PML)-retinoic acid receptor alpha (RARA) fusion transcript by polymerase chain reaction (PCR) analysis but have normal chromosomes. X. To estimate the proportion of patients with variant RARA partners. XI. To compare the outcome of patients with only a t(15;17) with that of patients who carry a t(15;17) and other chromosomal abnormalities. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 arms based on risk factor (standard-risk \[WBC less than 10,000/mm\^3\] or high-risk \[WBC 10,000/mm\^3 or higher\]). ARM I (STANDARD-RISK): INDUCTION THERAPY: Patients receive tretinoin orally (PO) twice daily (BID) on days 1-30 and idarubicin intravenously (IV) over 15 minutes once on days 3, 5, and 7. CONSOLIDATION THERAPY: CONSOLIDATION 1: Patients receive arsenic trioxide IV over 2 hours on days 1-5, 8-12, 15-19, 22-26, and 29-33 and tretinoin PO BID on days 1-14. Treatment repeats every 5 weeks for 2 courses, followed by a 2-week break, and then treatment repeats for 2 more courses. Beginning 1 week later or when blood counts recover, patients proceed to consolidation 2. CONSOLIDATION 2: Patients receive cytarabine intrathecally (IT) on day 1, tretinoin PO BID on days 1-14, high-dose cytarabine IV over 3 hours every 12 hours on days 1-3, and mitoxantrone hydrochloride IV over 15-30 minutes once on days 3 and 4. Patients proceed to consolidation 3 1 week later or when blood counts recover. CONSOLIDATION 3: Patients receive cytarabine IT on day 1, tretinoin PO BID on days 1-14, and idarubicin IV over 15 minutes once daily on days 1, 3, and 5. High-risk patients and those standard-risk patients who are positive for minimal residual disease by real-time quantitative (RQ)-PCR receive consolidation 4 one week later or when blood counts recover. All other standard-risk patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive cytarabine IT on day 1 (course 1 only), tretinoin PO BID on days 1-14, mercaptopurine PO once daily (QD) on days 1-84, methotrexate PO once on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for 9 courses. ARM II (HIGH-RISK): INDUCTION THERAPY: Patients receive tretinoin PO BID on days 1-30 and idarubicin IV over 15 minutes once on days 1, 3, and 5. Patients proceed to consolidation therapy one week later or when blood counts recover. CONSOLIDATION THERAPY: Patients receive consolidation 1, 2, and 3 as in Arm I. CONSOLIDATION 4: Patients receive cytarabine IT on day 1, tretinoin PO BID on days 1-14, high-dose cytarabine IV over 3 hours every 12 hours on days 1-3, and idarubicin IV over 15 minutes once on day 4. Patients who demonstrate molecular complete remission (CR) and remain in hematological CR proceed to maintenance therapy 1 week later or when blood counts recover. MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm I. After completion of study treatment, patients are followed every month for 1 year, every 3 months for 2 years, every 6 months for 2 years, and then annually for 5 years. #Intervention - DRUG : Arsenic Trioxide - Given IV - Other Names : - Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid, Arsenous Acid Anhydride, Arsenous Oxide, ATO, Trisenox, White Arsenic - DRUG : Cytarabine - Given IT or IV - Other Names : - .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453 - OTHER : Diagnostic Laboratory Biomarker Analysis - Correlative studies - DRUG : Idarubicin - Given IV - Other Names : - 4-Demethoxydaunomycin, 4-Demethoxydaunorubicin, 4-DMDR - DRUG : Mercaptopurine - Given orally - Other Names : - 3H-Purine-6-thiol, 6 MP, 6 Thiohypoxanthine, 6 Thiopurine, 6-Mercaptopurine, 6-Mercaptopurine Monohydrate, 6-MP, 6-Purinethiol, 6-Thiopurine, 6-Thioxopurine, 6H-Purine-6-thione, 1,7-dihydro- (9CI), 7-Mercapto-1,3,4,6-tetrazaindene, Alti-Mercaptopurine, Azathiopurine, Bw 57-323H, Flocofil, Ismipur, Leukerin, Leupurin, Mercaleukim, Mercaleukin, Mercaptina, Mercaptopurinum, Mercapurin, Mern, NCI-C04886, Puri-Nethol, Purimethol, Purine, 6-mercapto-, Purine-6-thiol (8CI), Purine-6-thiol, monohydrate, Purinethiol, Purinethol, U-4748, WR-2785 - DRUG : Methotrexate - Given orally - Other Names : - Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039 - DRUG : Mitoxantrone Hydrochloride - Given IV - Other Names : - CL 232315, DHAD, DHAQ, Dihydroxyanthracenedione Dihydrochloride, Mitoxantrone Dihydrochloride, Mitoxantroni Hydrochloridum, Mitozantrone Hydrochloride, Mitroxone, Neotalem, Novantrone, Onkotrone, Pralifan - DRUG : Tretinoin - Given orally - Other Names : - 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin

#Eligibility Criteria: Inclusion Criteria: * Patients must be newly diagnosed with a clinical diagnosis of acute promyelocytic leukemia initially by morphology (bone marrow or peripheral blood); bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted; APL is considered a hematological emergency and treatment should be initiated as quickly as possible without waiting for molecular or cytogenetic/fluorescence in situ hybridization (FISH) confirmation; for patients who are unable to begin receiving ATRA in a timely manner following a presumed diagnosis of APL, consideration should be given to initiating ATRA and proceeding with treatment outside of the AAML0631 protocol; if the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR to be eligible; patients without evidence of APL by bone marrow or peripheral blood morphology but with isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible provided that the t(15;17) translocation is documented on either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment; in this situation, touch preps from the tumor site can be evaluated by FISH with PML-RARA probes; NOTE: A lumbar puncture is not required to be enrolled on study; if the diagnosis of APL is known or suspected, extreme caution must be exercised in performing a lumbar puncture during active coagulopathy; in addition a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma if central nervous system (CNS) disease is suspected or proven; if CNS disease is documented, patients are still eligible * No minimal performance status criteria * The patient must not have received systemic definitive treatment for APL or other suspected leukemia, including cytotoxic chemotherapy, retinoids, or arsenic; prior therapy with corticosteroids, hydroxyurea, or leukopheresis will not exclude the patient; if a patient received intrathecal cytarabine prior to the diagnosis of APL being known, the patient will still be eligible as long as they meet all other eligibility requirements Exclusion Criteria: * Pregnant women or nursing mothers are excluded; treatment under this protocol would expose an unborn child to significant risks; patients should not be pregnant or plan to become pregnant while on treatment; women and men of reproductive potential should agree to use an effective means of birth control; there is an extremely high risk of fetal malformation if pregnancy occurs while on ATRA in any amount even for short periods * Patients with a pre-existing prolonged QT Syndrome will not be eligible for this protocol due to the use of arsenic trioxide which can prolong the QT interval Sex : ALL Ages : - Minimum Age : 2 Years - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00866918

{ "NCT_ID" : "NCT01969448", "Brief_Title" : "Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction", "Official_title" : "A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction", "Conditions" : ["Ductal Carcinoma in Situ - Category", "Breast Cancer", "Prophylactic Mastectomy"], "Interventions" : ["Procedure: Inframammary Fold Incision or Lateral Radial Incision", "Device: Laser-assisted fluorescence angiography", "Drug: Indocyanine Green", "Procedure: Inframammary Fold Incision", "Procedure: Lateral Radial Incision"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times. #Intervention - PROCEDURE : Inframammary Fold Incision or Lateral Radial Incision - PROCEDURE : Lateral Radial Incision - PROCEDURE : Inframammary Fold Incision - DEVICE : Laser-assisted fluorescence angiography - Other Names : - Spy Elite, LifeCell. - DRUG : Indocyanine Green

#Eligibility Criteria: Inclusion Criteria: * Patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (NASSM) procedure with planned immediate reconstruction. * Patient must be 18 years or older. * Karnofsky Performance Scale of at least 80%. * Patient must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Cognitive impairment. * BMI < 18 or > 35 * Breast >800 grams or <100 grams in predicted weight. 'Breast' includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass. The sum total must be >100 g and <800 g. * History of radiation to the chest wall or breast being studied * Patients who have a history of allergy to iodides or iodinated contrast agents * Surgeon's opinion at the time of surgery that the subject's well-being would be compromised (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems). If the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01969448

{ "NCT_ID" : "NCT01367652", "Brief_Title" : "Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions", "Official_title" : "A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fasted Conditions", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Letrozole"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted conditions. #Intervention - DRUG : Letrozole - 2.5 mg tablet - Other Names : - Femara - DRUG : Letrozole - 2.5 mg Tablet - Other Names : - Femara

#Eligibility Criteria: Inclusion Criteria: * No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: * Positive test for HIV, Hepatitis B, or Hepatitis C. * Treatment with known enzyme altering drugs. * History of allergic or adverse response to letrozole or any comparable or similar product. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01367652

{ "NCT_ID" : "NCT01957735", "Brief_Title" : "BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors", "Official_title" : "A Phase 1a/b Non-randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously to Patients With Solid Tumors", "Conditions" : ["Metastatic Cancer", "Cancer", "Solid Tumor"], "Interventions" : ["Drug: BP31510 in combination with chemotherapy", "Drug: BP31510 monotherapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors. Detailed Description This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1)and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors.In the Phase 1a portion of the trial, patients who meet eligibility parameters will receive 2 consecutive 72-hour infusions of BPM31510 twice weekly on Tuesday and Friday (i.e., Days 1, 4, 8, 11, 18, 22 and 25), essentially receiving BPM31510 treatment for 144 hours per week of each 28-day cycle. At each dose level of Arm 1 and Arm 2, patients will be treated for either 8 hours at minimum of outpatient monitoring or inpatient monitoring for the first 24-hrs of the first infusion of Cycle 1.All other treatments will be administered in an outpatient setting.Dose limiting toxicities will be assessed during Cycle 1. The study is a standard 3 + 3 dose escalation design with the dose escalated in successive cohorts of 3 to 6 patients each.Toxicity at each dose level will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.02). Safety oversight will be provided by the Cohort Review Committee (CRC).The CRC will review and confirm all DLTs and will continue to monitor safety throughout the study (including Arm 2). Assessments of the antitumor activity of BPM31510 will be performed at the end of Cycle 2 and every 2 cycles thereafter using standard techniques such as computerized tomography (CT) or magnetic resonance imaging (MRI) for patients with measurable disease.Response will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 .Patients who experience no unacceptable toxicity or disease progression, may receive additional 28-day cycles for up to 1 year on Arm 1 or 2. Patients on Arm 1 who progress may elect to continue BPM31510 treatment in combination with gemcitabine, 5-FU, or docetaxel at the treating physician's discretion. Once a dose level of BPM31510 monotherapy is evaluated and the CRC determines it safe to escalate to the next dose level, Cohort 1 of Treatment Arm 2 of BPM31510 in combination with chemotherapy will open to accrual. Cohort 1 of Arm 2 patients will be enrolled onto one of 3 chemotherapies, gemcitabine, 5-FU, or docetaxel. Cycle 1 of combination therapy (Arm 2) is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesday and Friday for 6 weeks and chemotherapy administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesday and Friday for 4 weeks and chemotherapy administered on Mondays, Days 7, 14 and 21. Dose limiting toxicities will be assessed during Cycle 1. Response will be assessed after Cycle 2 (10 weeks) and responders who continue onto Cycles 2-12 will be assessed every 2 cycles (8 weeks). Patients who progress and crossover to Arm 2 will be reconsented and must meet eligibility before restarting BPM31510. Crossover patients are not evaluated for DLTs on Arm 2 and all cycles of combination therapy are 4 weeks in duration (Cycles 1-12). BPM31510 is administered twice weekly on Tuesdays and Fridays for 4 weeks and chemotherapy administered on Mondays, Days 7, 14 and 21 for all crossover patients on Arm 2. Patients will continue BPM31510 in combination with chemotherapy for a maximum of 12 cycles in the absence of intolerable toxicity and progression. Patients on Arm 2 who progress on one type of chemotherapy may not switch to one of the other chemotherapy agents in combination with BPM31510.However, if the chemotherapy component (ie, 5-FU, gemcitabine, or docetaxel) of combination therapy is discontinued due to chemotherapy-related toxicity, patients may continue to receive BPM31510 as monotherapy. Once the maximum tolerated dose (MTD) of BPM31510 as monotherapy and in combination with chemotherapy are established, an expansion cohort will be enrolled (a total of 12-15 patients for monotherapy and a total of 10 patients for each combination therapy). #Intervention - DRUG : BP31510 monotherapy - DRUG : BP31510 in combination with chemotherapy

#Eligibility Criteria: Inclusion Criteria: * The patient has a histologically confirmed solid tumor that is metastatic or unresectable for which standard measures do not exist or are no longer effective. (Patients with primary brain cancer or lymphoma are permitted. Patients with brain metastases are allowed if whole brain radiation was performed and is documented stable for >= 6 weeks) * The patient is at least 18 years. * The patient has an Eastern Cooperative Oncology Group (ECOG) performance status <= 2 * The patient has a life expectancy of > 3 months. * Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study * Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment. * The patient has adequate organ and marrow function as follows: * ANC >= 1500 mm3, platelets >= 100,000/mm3, hemoglobin >= 9 g/dL, * serum creatinine <=1.8 mg/dL or creatinine clearance > 50 mL/min (Appendix I); * bilirubin <= 1.5 mg/dL; alanine aminotransferase (ALT), aspartate transaminase (AST) <= 2.5 times the upper limit of normal if no liver involvement or <= 5 times the upper limit of normal with liver involvement. * The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed). * The patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (PTT), and an International Normalized Ratio within normal limits. * The patient is capable of understanding and complying with the protocol and has signed the informed consent document. Exclusion Criteria: * The patient has uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * The patient has active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV) * The patient has received chemotherapy or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of study drug. * The patient has received radiation to >= 25% of his or her bone marrow within 4 weeks of the first dose of study drug. * The patient has received an investigational drug within 30 days of the first dose of study drug. * The patient has not recovered to grade <= 1 adverse events (AEs) due to investigational drugs or other medications, administered more than 2 weeks prior to the first dose of study drug, with the exception of neurotoxicity attributed to oxaliplatin or taxanes, which must have recovered to < 2 prior to study initiation. * The patient is pregnant or lactating. * The patient is known to be positive for the human immunodeficiency virus (HIV). The effect of BPM31510 on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study. * The patient has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee. * The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids. * The patient is receiving colony stimulating factors (CSFs) that cannot be held during the monitoring period for dose-limiting toxicities (DLT). * The patient has uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, such as hemoptysis, epistaxis, hematochezia, hematuria, or gastrointestinal bleeding. * The patient has a known predisposition for bleeding such as von Willebrand's disease or other such condition. * The patient requires therapeutic doses of any anticoagulant, including LMWH. Concomitant use of warfarin, even at prophylactic doses, is prohibited. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01957735

{ "NCT_ID" : "NCT01442285", "Brief_Title" : "The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)", "Official_title" : "The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)", "Conditions" : ["Cancer", "Distress"], "Interventions" : ["Behavioral: personalized, motivational messages"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to understand more about meeting the psychosocial needs of people who have cancer. Detailed Description The investigators are interested in the feasibility of using computer assisted screening and assessment to meet the psychosocial needs of people with cancer. The investigators are studying two different interventions. Both groups will receive health information, referral information, and resources. One group will also receive tailored feedback reports. #Intervention - BEHAVIORAL : personalized, motivational messages - A Healthcare Provider Report will be printed after each assessment and reviewed by the subject's oncologist. If any mental health functioning scale scores fall in the elevated or high range, a treatment plan will be constructed. Subjects will receive a personalized Patient Feedback Report after each assessment which will include motivationally tailored messages and suggestions for action. - Other Names : - motivational counseling

#Eligibility Criteria: Inclusion Criteria: * cancer diagnosis Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01442285

{ "NCT_ID" : "NCT02939300", "Brief_Title" : "Ipilimumab and Nivolumab in Leptomeningeal Metastases", "Official_title" : "Phase II Trial of Ipilimumab and Nivolumab in Leptomeningeal Metastases", "Conditions" : ["Leptomeningeal Carcinomatosis"], "Interventions" : ["Drug: Ipilimumab", "Drug: Nivolumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This research study is studying a combination of two drugs as a possible treatment for Leptomeningeal Metastases. The names of the study interventions involved in this study are: * Ipilimumab * Nivolumab Detailed Description This research study is a Phase II clinical trial. Researchers hope to study the effects of the combination of Nivolumab and Ipilimumab. Many cancers use specific pathways, such as programmed death-1 (PD-1), programmed death-ligand-1 (PD-L1), and cytotoxic T lymphocyte antigen-4 (CTLA-4), to evade the body's immune system. Nivolumab and ipilimumab work by blocking the PD-1/PD-L1 and CTLA-4 pathways and thus releasing the brakes on the immune system so it can stop or slow cancer. The FDA (the U.S. Food and Drug Administration) has approved Nivolumab and Ipilimumab as a treatment option for melanoma, but has not approved them for use when cancer cells spread to the cerebrospinal fluid #Intervention - DRUG : Nivolumab - * Melanoma: - Combination therapy with Nivolumab 1 mg/kg for 4 doses followed by monotherapy Nivolumab 480 mg per cycle. * Non-small Cell Lung Cancer / Head and Neck Cancer: - Combination therapy with Nivolumab 3 mg/kg * Small Cell Lung Cancer / Breast Cancer / Bladder Cancer: - Combination therapy with Nivolumab 1 mg/kg for 4 doses followed by monotherapy Nivolumab 240 mg per cycle. * Renal Cell Carcinoma / Other Solid Tumors (not listed above): * Combination therapy with Nivolumab 3 mg/kg for 4 doses followed by monotherapy Nivolumab 480 mg per cycle. - Other Names : - Opdivo - DRUG : Ipilimumab - * Non-small Cell Lung Cancer / Head and Neck Cancer: - Combination therapy with Ipilimumab 1 mg/kg * Small Cell Lung Cancer / Breast Cancer / Bladder Cancer: - Combination therapy with Ipilimumab 3 mg/kg for 4 doses * Renal Cell Carcinoma / Other Solid Tumors (not listed above): * Combination therapy with Ipilimumab 3 mg/kg for 4 doses - Other Names : - Yervoy

#Eligibility Criteria: Inclusion Criteria: * Participants must have histologically or cytologically confirmed disease from any solid tumor * Age >=18 years. * Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Karnofsky >=60%) * Life expectancy of greater than 3 weeks * Participants must have normal organ and marrow function as defined below, all screening labs should be performed within 10 days of treatment initiation. Adequate Organ Function Laboratory Values: Unit key: mcL = microliter, ULN = upper limit normal * Hematological * Absolute neutrophil count (ANC) >=1500 /mcL * Platelets >=100,000 / mcL * Hemoglobin >=9 g/dL or >=5.6 mmol/L without transfusion or Erythropoietin (EPO) dependency (within 7 days of assessment) * Renal * Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) <= Serum creatinine <= 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula below): * Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL * Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL * Hepatic * Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN * Aspartate transaminase (AST) and Alanine transaminase (ALT) <= 3 ULN OR <= 5 X ULN for subjects with liver metastases * Albumin >= 2.5 mg/dL * Coagulation * International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Activated Partial Thromboplastin Time (aPTT) <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Creatinine clearance should be calculated per institutional standard. * Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. 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. * Women of childbearing potential 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 Nivolumab * Women must not be breastfeeding * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential, ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception * Ability to understand and the willingness to sign a written informed consent document. * Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment * Carcinomatous meningitis, as defined by positive cytology Exclusion Criteria: * Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier. Subjects with <= Grade 2 neuropathy are an exception to this criterion and may qualify for the study. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Participants who are receiving any other investigational agents. * Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger * Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted. * As there is potential for hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab-containing regimen. * Patients should be excluded if they have had prior systemic treatment with an anti-CTLA4 antibody * Has a known history of active TB (Bacillus Tuberculosis) * Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection * Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. * 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. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has known history of, or any evidence of active, non-infectious pneumonitis. * Has an active infection requiring systemic therapy. * Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. * History of allergy to study drug components * History of severe hypersensitivity reaction to any monoclonal antibody Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02939300

{ "NCT_ID" : "NCT02834364", "Brief_Title" : "BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)", "Official_title" : "LGX818 in Combination With MEK162 in Refractory or Relapsed Multiple Myeloma Patients With BRAFV600E or BRAFV600K Mutation", "Conditions" : ["Relapsed or Refractory Multiple Myeloma", "Patients With BRAFV600 E or BRAFV600K Mutation"], "Interventions" : ["Drug: Binimetinib", "Drug: Encorafenib"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Trial for patients with refractory multiple myeloma after failure of at least two treatment regimens and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors Encorafenib (LGX818 in) combination with Binimetinib (MEK162). Detailed Description An open-label, single-arm, multi-centre phase II trial for patients with refractory multiple myeloma and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors Encorafenib (LGX818 in) combination with Binimetinib (MEK162). The patients must have received at least two prior therapy regimen (at least one immunomodulatory drug and one proteasome inhibitor). The subjects receive LGX 818 450 mg. p.o. once daily and MEK 162 45 mg p.o. twice daily until disease progression or toxicity requiring discontinuation of treatment. 1 cycle is defined as 28 days. #Intervention - DRUG : Encorafenib - 450 mg p.o. once daily. One cycle is defined as 28 days - Other Names : - LGX818 - DRUG : Binimetinib - 45 mg p.o. twice daily. One cycle is defined as 28 days - Other Names : - MEK162

#Eligibility Criteria: Inclusion Criteria: * Patient has provided a signed study Informed Consent Form prior to any study-specific procedure and is able to comply with protocol requirements * Patients with multiple myeloma,relapsed or refractory after failure of two or more lines of systemic treatments. All patients must have received at least one immunomodulatory drug (IMiD) and a proteasome inhibitor. Multiple myeloma requiring systemic therapy must have been confirmed in the medical history of the patients with criteria established by the International Myeloma Working Group (IMWG) (Rajkumar V et al. Lancet International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet 2014; 15: 538 <= age <= 548) * Written confirmation of BRAFV600E mutation or BRAFV600K mutation in in the majority of myeloma cells, defined by positive IHC staining with mutations specific antibody of >= 50% in the respective biopsy, confirmed by DNA sequencing of the corresponding codon * Measurable disease, as defined as: Measurable levels of myeloma paraprotein in serum (>= 0.5 g/dL) or urine (>= 0.2 g/24 hours) or FLC of involved light chain > 100mg/l and abnormal FLC-ratio * Age >=18 * WHO performance status 0 <= age <= 3 (WHO 3 is allowed only when caused by MM and not by comorbid conditions) (see Appendix 3) * Negative pregnancy test within 72 hours of inclusion (women of childbearing potential): For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy (see also exclusion criteria). * All patients must agree to abstain from donating blood while on study * Adequate cardiac function: left ventricular ejection fraction (LVEF) >= 50% as determined by an echocardiogram, QTc interval <= 450 ms * Ability of subject to take oral medications * Ability of subject to understand character and individual consequences of clinical trial Exclusion Criteria: * Patient with prior treatment with MEK and/or RAF inhibitors * Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow) * Patients with meningeosis or central nervous system lesion(s) caused by multiple myeloma. However, patients treated with stereotactic radiotherapy or surgery are eligible if patient remained without evidence of CNS disease progression >= 4 weeks. * History or current evidence of retinal vein occlusion (RVO) or predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) * History of retinal degenerative disease * Plasma cell leukaemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2/nl. * Patient has received radiotherapy (including therapeutic radioisotopes) <= 21 days, if not restricted to a single osteolytic lesion, or has not recovered from side effects of such therapy. * Patient has had major surgery within 21 days prior to starting study drug or has not recovered from major side effects of the surgery. Kyphoplasty as prevention of skeletal related events is allowed. * Patient is concurrently using other approved antineoplastic or any investigational agents in the last 14 days prior to start of treatment. Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 4 weeks prior to study entry. * Impaired cardiovascular function or clinical significant cardiovascular disease including any of the following: Symptomatic chronic heart failure, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality <6 months prior to Screening except atrial fibrillation and paroxysmal supraventricular tachycardia; 1. LVEF < 50% as determined by ECHO, or uncontrolled hypertension despite medical treatment (please refer to WHO ISH guidelines) 2. Clinically significant resting bradycardia, unstable angina pectoris <= 3 months prior to starting study drug, history of acute coronary syndromes (including myocardial infarction, coronary artery bypass grafting, coronary angioplasty, or stenting) <6 months prior to screening 3. QTcF > 450 msec 4. patients with acute diffuse infiltrative pulmonary and pericardial disease * Significant hepatic dysfunction (serum bilirubin >= 2 mg/dl or ASAT and/or ALAT >= 2.5 times normal level), unless related to myeloma * Active hepatitis B, and/or active hepatitis C infection * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818/MEK162 (e.g., ulcerative diseases, uncontrolled nausea,vomiting, diarrhea, malabsorption syndrome, small bowel resection). * Gilbert´s syndrome * Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) * Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment. Note: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment * Patients known to be HIV-positive * Patients with active, uncontrolled infections (patients successful treated with antimicrobial therapy may be enrolled at the discretion of the investigator). * Patient is receiving chronic treatment with systemic steroids or another immuno-suppressive agent at start of study treatment. Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) and the use of systemic steroids up to a prednisone equivalent of 10 mg daily are allowed. * Patient has consumed Seville oranges, grapefruit, grapefruit hybrids, pomelos and exotic citrus fruits (as well as their juices) during the last 7 days prior to start of treatment. Regular orange juice is permitted. * Second malignancy within the past 3 years except: 1. Adequately treated basal cell or squamous cell skin cancer (adequate wound healing is required prior to entry in the study) 2. Adequately treated carcinoma in situ of the cervix, 3. Prostate Cancer not requiring systemic treatment or under anti-hormonal treatment and PSA-level below upper level of normal range. 4. Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), 5. solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry 6. Similar condition with an expectation of > 95 % 5-year disease free survival * Patients with any of the following laboratory values at Screening/Baseline. 1. Absolute neutrophil count (ANC) <1,000/mm3 [1.0 x 109/L] without Growth factor support in the last 7 days 2. Platelets <= 50000/mm3 [50 x 109/L] ; patients with platelets 75000- 50000/ mm3 are eligible if thrombocytopenia is confirmed as related to myeloma bone marrow infiltration and pt. is able to receive thrombocyte concentrates 3. Hemoglobin < 8.0 g/ dl (unless confirmed related to myeloma bone marrow infiltration and pt. able to receive blood transfusions) 4. Serum creatinine >2 x ULN or calculated or directly measured CrCl <= 45 ml/min; patients with creatinin-clearance between 30 <= age <= 45 ml/min can be enrolled with approval by the coordinating investigator. * Clinically significant autoimmune haemolytic anaemia with positive Coombs test or immune thrombocytopenia * Patient is a woman of child-bearing potential, UNLESS they are using a double barrier method for birth control throughout the trial. 1. Hormonal contraceptives may be affected by cytochrome P450 interactions, and are therefore considered neither indicated nor effective. 2. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper), sponge or spermicide. 3. Reliable contraception has to be maintained throughout the study and for 12 weeks after study drug discontinuation. 4. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential * Sexually active males unless they agree to use a condom during intercourse while taking the drug. This practice should be continued for another 12 weeks after stopping treatment. Also they should not father a child during the study period or the 12 weeks post study time. A condom is also required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid; * Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study. * Patients taking non-topical medication known to be a strong inhibitor of CYP3A4. However patients who either discontinue their treatment or switch to another medication at least three days prior to registration are eligible. * Participation in other clinical trials within 1 month prior to enrolment except patients for supportive care studies and vaccination studies. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months. * Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g. uncontrolled diabetes, chronic pancreatitis, active chronic hepatitis ). No subject will be allowed to be enrolled in this trial more than once. * Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02834364

{ "NCT_ID" : "NCT00412503", "Brief_Title" : "Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents", "Official_title" : "Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents", "Conditions" : ["Refractory Tumors", "Malignant Tumors"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination. #Intervention - DRUG : Topotecan, Temozolomide

#Eligibility Criteria: Inclusion Criteria: * histologically documented malignant tumor * refractory or relapsing after conventional treatments and for which there is no curative treatment available * life expectancy > 8 weeks * no significant co-morbidity (NCI-CTC < 2) * No organ toxicity * no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy Exclusion Criteria: * Hypersensibility to Topotecan and/or Temozolomide or to one of their compounds * Hypersensibility to Dacarbazine (DTIC) * Galactosaemia, Glucose and galactose malabsorption syndrom, deficiency in lactase Sex : ALL Ages : - Minimum Age : 6 Months - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00412503

{ "NCT_ID" : "NCT01740323", "Brief_Title" : "Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy", "Official_title" : "Meriva for Treatment-induced Inflammation and Fatigue in Women With Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Placebo", "Drug: Curcumin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding and ultimately its downstream mediator IL-6 in patients receiving XRT for their breast cancer after having completed chemotherapy. Patients who have received prior chemotherapy will be eligible, because we have found that this enriched population is at particular risk for exhibiting increased NF-kB DNA binding and IL-6 following XRT. Detailed Description As many as 60% of breast cancer (BrCA) patients receiving radiation are known to develop fatigue with about 30% suffering persistent fatigue several months to years after treatment completion (12-23). The physical, psychological, and molecular mechanisms by which patients develop fatigue are poorly understood and most likely multi-factorial. One pathway that has received considerable attention is nuclear factor-kappa B (NF-kB)(24). The NF-kB pathway has emerged as having an important role not only in cancer treatment resistance but in the development of fatigue. NF-kB activation leads to over expression of interleukin (IL)-1beta, IL-6, and tumor necrosis factor (TNF)-alpha, all factors related to inflammation and factors that have been found to be upregulated in patients receiving radiation as well as BrCA survivors with fatigue (25-29). A recently published study looking at TNF-alpha, fatigue and cachexia in cancer patients receiving docetaxol showed that NF-kB is upregulated in fatigued patients and that agents which inhibit TNF-alpha lead to better tolerance of chemotherapy dose escalation (30). Work by our group and others has shown that ionizing radiation increases NF-kB pathway activity in circulating immune cells (as well as within breast cancer cells) and that this effect is most pronounced in women previously treated with chemotherapy (31, 32). Our work has shown that the NF-kB pathway activity in circulating immune cells is also related to fatigue development in BrCA patients treated with radiation and that patients most at risk for persistent fatigue and NF-kB pathway activity are those who have received chemotherapy for their breast cancer (31). Curcumin, a known inhibitor of NF-kB, has been shown to decrease NF-kB activation in human participants. In a recent study, 8 grams of curcumin by mouth daily for 8 weeks was well tolerated in patients with pancreatic cancer and other pre-malignant conditions with no associated toxicities (6, 8). Although there is concern over the body's absorption of curcumin, the bioavailability of curcumin in the study of pancreatic cancer patients was shown, with peak drug levels at 22 to 41ng/mL that remained relatively constant over the first 4 weeks of treatment with 8 grams of curcumin daily (8). Clinical trials with daily dosages of 1,125 to 2,500mg have also confirmed the safety of curcumin and also shown its ability to decrease inflammation in patients with rheumatoid arthritis and in post-operative patients (6, 33, 34). In vivo murine models of chronic fatigue syndrome have also shown that curcumin may also alleviate symptoms of fatigue (35). While these studies are promising, very little is known about the capacity of Meriva to inhibit NF-kB in women treated for BrCA. We hypothesize that oral Meriva, a known inhibitor of NF-kB, may be used to decrease levels of NF-kB activity in BrCA patients previously treated with chemotherapy who go on to receive radiotherapy (XRT), a carefully chosen group of patients at particular risk for high levels of NF-kB DNA binding (a direct measure of NF-kB pathway activity). We have chosen to administer oral Meriva, 500mg BID, in our patient population based on the above data. Meriva-500 is a curcumin formulation that also contains phosphatidylcholine, derived from soy that has been shown to aid in absorption of curcumin (9), permitting a lower overall dose of curcumin. Of note, 1000 mg Meriva contains 200 mg curcuminoids (\>90% curcumin). By decreasing activity of NF-kB and ultimately plasma IL-6, fatigue may improve in BrCA patients taking Meriva. Results from this study will contribute to the limited research available on the capacity of curcumin treatment, including Meriva, to inhibit NF-kB activation in vivo as well as symptoms of fatigue associated with excessive NF-kB pathway activity in BRCA patients. #Intervention - DRUG : Placebo - daily placebo for 6 weeks - DRUG : Curcumin - 500 mg BID - Other Names : - Meriva

#Eligibility Criteria: Inclusion Criteria: * Female breast cancer patients over the age of 18 will be recruited for this study. Patients enrolled in the study will meet standard criteria for whole breast XRT. Exclusion Criteria: * Subjects will be excluded for a number of medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, major psychiatric disorders, autoimmune or inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination and laboratory testing). Subjects with a history of a major psychiatric disorder including Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence within the past 1 year (as determined by standardized psychiatric interview) will be excluded. Subjects taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or other natural products with one week of starting medications, excluding vitamins and calcium supplementation or at the discretion of the attending physician, will be excluded. Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded. In addition, patients who develop evidence of infection (as determined by history, physical exam or laboratory testing) during the study will be discontinued from the study. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01740323

{ "NCT_ID" : "NCT04055142", "Brief_Title" : "Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males", "Official_title" : "A Phase III, Randomized, One-site, Pilot, Open-label, Parallel Groups Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males", "Conditions" : ["High-grade Anal Intraepithelial Neoplasia"], "Interventions" : ["Drug: sinecatechins 10% topical ointment", "Drug: cidofovir 1% topical ointment", "Procedure: electrocoagulation"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN). The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males. All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group. Detailed Description This Trial addresses one of the emerging problems in patients with HIV infection, such as the high incidence of anal dysplasia and anal cancer. The study proposes to evaluate new therapeutic options in the treatment of anal dysplasia, thus trying to overcome the current limitations of electrocoagulation (moderate efficacy, high recurrence, significant patient discomfort, and significant health cost). Topical cidofovir has shown (in a non-comparative study) efficacy and tolerance rates similar to those observed for electrocoagulation, although with the benefits of self-application by the patient. This makes it an attractive topical treatment option that requires a direct comparison with the currently chosen treatment, which is electrocoagulation. On the other hand, the medical properties of the sinecatechins, together with the results obtained in the treatment studies of oral and cervical dysplasia, and the possibility of being self, make this drug an attractive option to be evaluated experimentally in the treatment of anal dysplasia. Finally, the identification of prognostic markers of the disease should continue to be explored, in terms of the response to treatment and the recurrence of the disease. #Intervention - PROCEDURE : electrocoagulation - HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks) - DRUG : cidofovir 1% topical ointment - HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks) - Other Names : - Cidofovir - DRUG : sinecatechins 10% topical ointment - HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks) - Other Names : - Veregen ointment

#Eligibility Criteria: Inclusion Criteria: * Men who have sex with men, older or same than 18 years. * HIV-1 positive men. * High grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study. * Informed consent is signed voluntarily. Exclusion Criteria: * Patient with any disease or condition which rules him out to participate in the research, by investigator opinion. * Treated patients for HGAIN in the previous 6 months. * Patients with relapsed HGAIN two or more times in the last three months. * People with learning difficulties Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04055142

{ "NCT_ID" : "NCT00116441", "Brief_Title" : "Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma", "Official_title" : "Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line", "Conditions" : ["Multiple Myeloma"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line. #Intervention - BIOLOGICAL : Therapeutic Cellular Vaccine, GM-CSF Producing

#Eligibility Criteria: Inclusion Criteria: * De novo multiple myeloma * ECOG 0 <= age <= 2 * No serious co-morbid illnesses and adequate organ function * > 4 weeks from systemic steroids Exclusion Criteria: * No existing secondary malignancies and no history of secondary malignancies in the past 5 years * No active autoimmune disease Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00116441

{ "NCT_ID" : "NCT04232059", "Brief_Title" : "The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery", "Official_title" : "The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery: Randomized Controlled Cross Over Study", "Conditions" : ["Infratentorial Neoplasms", "Hyperventilation", "Craniotomy"], "Interventions" : ["Device: cerebral oximetry"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The aim of this study is to evaluate the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection. Detailed Description Introduction: Hyperventilation has been used for intraoperative brain relaxation for decades, Interestingly, this common practice is not based on robust evidence . The mechanism of brain relaxation secondary to hyperventilation is attributed to the hypocapnia induced cerebral vasoconstriction and the subsequent reduction of cerebral blood volume (CBV) and intracranial volume. The CBV reduction is accompanied by the reduction in cerebral blood flow that could render the brain at ischemic risk, if the cerebral metabolic activity remains the same before and after hyperventilation. So, it is possible that inadvertent cerebral ischemia may outweigh the benefits of hyperventilation and should be subjected for further investigation. Cerebral near-infrared spectroscopy (NIRS) is a useful non-invasive tool for regional cerebral oxygen saturation (rScO2) monitoring, which provides continuous, real time information on the balance between cerebral oxygen delivery and consumption. Cerebral oximetry monitoring had the ability to detect clinically silent episodes of cerebral ischemia in a variety of clinical settings which could be an important safeguard for cerebral function. Hyperventilation had been shown to significantly reduce cerebral oxygenation using near-infrared spectroscopy in patients undergoing elective abdominal surgery. Multiple studies have shown that prolonged hyperventilation correlated with poor outcome especially in brain injured patients. 5,6 However, there is still a lack of evidence on the relationship between hyperventilation and neurological outcome in patients having craniotomy. However, to the best of the investigator's knowledge no previous randomized controlled trials had studied the effect of hyperventilation versus normo-ventilation on cerebral oximetry in pediatrics undergoing posterior fossa tumor surgeries. V. Study procedure: This is a prospective, randomized controlled trial with a two-period crossover design so that the patient can act as a control to himself. Enrolled patients are children (1-6 years old) undergoing posterior fossa tumor resection. Prior to anesthetic induction, the two sensors (SAFB-SM, Covidien, Dublin, Ireland) for near-infrared spectroscopy (INVOS 5100C, Covidien, Dublin, Ireland) will be applied on the left and right sides of the forehead with the caudal border approximately 1 cm above the eyebrows to measure regional oxygen saturation (rSO2). A bispectral index (BIS) sensor will also be fixed on the left forehead (Model QUATRO, Covidien, Dublin, Ireland) to monitor the depth of anesthesia. Both sensors will be fixed to their positions using adhesive pads to avoid removal during positioning and soaking with betadine solution. Baseline values for cerebral oxygen saturation will be obtained using NIRS monitor, Standard monitors (electrocardiogram, non-invasive blood pressure, pulse oximeter) will be applied to all patients. The anesthetic management will be standardized for all patients as follows: General anesthesia will be induced by inhalational agent 'sevoflurane' until intravenous line is secured then Fentanyl (1-2 µg/kg), Propofol (1-2 mg/Kg) will be given intravenously. Intubation will be facilitated by Atracurium (0.5 mg/kg) and confirmed by capnography. Nasopharyngeal temperature probe will be inserted for monitoring of core body temperature which will be kept between 36.5-37 C using warming blankets. A 22 G arterial cannula will be placed in the left radial artery and baseline ABG will be obtained to correlate value of Etco2 and Paco2. Anesthesia will be maintained with isoflurane in oxygen 40% and will be adjusted to maintain BIS between 40 and 60 and Atracurium infusion (0.5 mg/kg/hr). Central venous line will be inserted in the right internal jugular vein under complete aseptic condition under ultrasound guidance, wide bore peripheral cannula will be inserted for fluid management and a Foley's catheter will be inserted in the urinary bladder for urine output monitoring. Patients will be positioned in the prone position with the arms positioned and secured at the patient's side and after careful padding of the pressure points; the patient head will be supported on the forehead using a horseshoe adapter. Slight neck flection will be permitted till the anesthetist can pass two fingers easily between the chin and the chest to allow for optimum surgical exposure. Patients will be randomly assigned using concealed envelopes, according to a computer-generated random number to one of the following two treatment sequences: * Group 1: hyperventilation (ETco2 25-30 mm Hg) for 20 minutes that will start immediately after skin incision followed by normoventilation (ETco2 31-35 mm Hg) for another 20 minutes. * Group 2: normoventilation (ETco2 31-35 mm Hg) for 20 minutes immediately after skin incision followed by hyperventilation (ETco2 25-30 mm Hg) for another 20 minutes. The ventilation strategies will be achieved using volume-controlled mode with a tidal volume of 8 ml/kg, I/E ratio:1/2 and ETco2 will be maintained at the desired range by adjusting the respiratory rate. Positive end-expiratory pressure (PEEP) will not be applied. After removal of the bone flap and exposure of the dura matter, a 20-gauge plastic cannula will be inserted into the subdural space along the surface of the brain. This will be connected to a calibrated pressure transducer via a length of polyethylene high pressure tubing filled with normal saline. The transducer will be zeroed at ear level. During the study period, the mean subdural pressure will be recorded at 2 minutes intervals at the end expiratory phase. Assessment phase 1: An arterial blood sample will be obtained immediately after skin incision for blood gas analysis to determine the difference between arterial and end-tidal carbon dioxide tension (Pa-ETCO2). Ventilation and ETCO2 will be kept constant for at least 20 min, which is long enough for stabilization of any vascular responses to the change in Paco2. At the end of the equilibration period (20 minutes), another arterial blood sample will be obtained to confirm that the targeted Paco2 (was achieved. The neurosurgeon, unaware of the anesthetic and ventilatory management provided, will be then asked to score the brain bulk according to a four-point scale as follows: 1. Excellent with no swelling 2. Minimal swelling, acceptable 3. Swollen but no treatment required 4. Swollen, needing treatment. After this assessment, ventilation will be changed immediately according to group assignment. Assessment phase 2: Another 20 min of equilibration will be allowed and measurements will be repeated as previously described. During the whole period of study (40 minutes), the cerebral oximetry will be recorded at 5 minutes intervals. During this period factors that may affect cerebral oximeter will be controlled by maintaining position of the patient head, (normothermia with temperature at 36.5-37 C), within 20% of the base line blood pressure using increments of ringer solution and ephedrine boluses as appropriate, maintain PH 7.35-7.45, Hb level around 10 gm/dl guided by blood loss and repeated measurements of Hb in ABG and blood glucose level between 80-180 mg/dl. The study will be ended at this point, the subdural cannula will be removed, and surgery will proceed as normal. Specific or routine interventions for brain swelling such as a change in body position or diuretic therapy with mannitol or furosemide will not be administered until the study had ended. However, for ethical reasons, interventions will be made if requested by the surgeon and the patient will be then withdrawn from the study. Data will be collected by an independent blinded anesthesiologist using a data collection form. • Measurement tools: * Demographic and categorical characteristics including patient's age in years, weight in Kg, gender, type of the procedure( 4th ventricular, medulloblastoma,... ) * Both NIRS values at baseline and every 5 minutes during each phase of the study * Subdural intracranial pressure (ICP) every 2 minutes during each phase of the study * End tidal co2 every 5 minutes during each phase of the study * Paco2 baseline and at the end of each phase of ventilation (20 minutes following start of phase 1 assessment and 20 minutes after start of phase 2 assessment) * Heart rate and mean arterial blood pressure every 10 minutes. * Brain relaxation score #Intervention - DEVICE : cerebral oximetry - evaluation of the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.

#Eligibility Criteria: Inclusion Criteria: * Age : 1 <= age <= 6 old * Both sexes * ASA I-II * scheduled for posterior fossa tumor resection. Exclusion Criteria: * Age < 1 year or > 6 years * Comorbid condition (ASA classification > II) * patient with anemia (Hb <10 g/dl) * Emergency surgery * Patients with VP shunt, on diuretics, recurrent tumors, cerebral infarction and or hemorrhage * Patients on cardiovascular support e.g.:, inotrope or vasoconstrictor infusions Sex : ALL Ages : - Minimum Age : 1 Year - Maximum Age : 6 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT04232059

{ "NCT_ID" : "NCT03167762", "Brief_Title" : "Photographing the Skin During Photodynamic Therapy", "Official_title" : "Fluorescence and Thermal Imaging of the Skin Before and During Photodynamic Therapy", "Conditions" : ["Basal Cell Carcinoma", "Bowen's Disease"], "Interventions" : ["Device: Fluorescence and thermal imaging"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Photodynamic therapy (PDT) is used to treat some types of sun-damaged skin and low-grade forms of growths. A cream is applied to the skin, and the chemical in this cream is absorbed in to the skin and converted in to a 'photosensitiser'. This photosensitiser is fluorescent, meaning that it produces red light when blue light is shone on it. By measuring how much light is given off with a camera, the investigators can determine how much photosensitiser is present in the skin. Also, it is thought that more of the chemical is converted to the active photosensitiser if the skin is warmer, so the investigators plan to measure the temperature of the skin using a thermal camera. Light is shone on to the skin and this activates the photosensitiser, treating the problem area and leaving healthy skin intact. This research will increase the investigators understanding of how PDT works, and may help the investigators to improve treatment regimens so that they can be made more effective and better tolerated #Intervention - DEVICE : Fluorescence and thermal imaging - Two cameras used to take images of the skin. One, to measure the fluorescence from the photosensitiser, and the second to measure the surface temperature of the skin

#Eligibility Criteria: Inclusion Criteria: * 1. Patients presenting with superficial BCC or Bowen's disease (one or two lesions and diagnosed either clinically or histologically and untreated or having had no treatment for 4 months or longer) 2. Adult males and females, >18 years only 3. Capable of giving informed consent 4. Able to understand and adhere to protocol requirements Exclusion Criteria: * 1. Patients skin lesions have had previous treatment in the last 4 months 2. Unable to give informed consent 3. Known allergy to Metvix® 4. Known to have a light sensitive disorder 5. Pregnant, breastfeeding or planning to conceive Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03167762

{ "NCT_ID" : "NCT03183765", "Brief_Title" : "Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts", "Official_title" : "Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts : a Randomized Controlled Trial", "Conditions" : ["Common Wart", "Plantar Wart"], "Interventions" : ["Procedure: cryotherapy", "Drug: Measles-Mumps-Rubella Vaccine"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct person-to-person contact or indirectly by fomites . Warts appear in various forms including verruca vulgaris, plane, plantar, filiform, digitate and periungual. Detailed Description Treatment of warts is difficult for patients and physicians . Currently Available treatment options include cryosurgery, laser, electrosurgery, bleomycin, and topical keratolytic applications; many of them are painful, ineffective, costly and prone for recurrences. Cryotherapy, which uses liquid nitrogen to freeze tissues and destroy warts, is one of the most common and effective treatments. freezing causes local irritation, leading the host to mount an immune reaction against the virus. Immunotherapy appears to enhance virus recognition by immune system; allowing clearance of treated wart, distant warts , and helps to prevent infection .Recently, intralesional immunotherapy using different antigens such as mumps, Candida, and tuberculin has been proved effective in the treatment of warts. The exact mechanism of action of intralesional immunotherapy is still obscure. Intralesional antigen injection probably induces strong non specific inflammatory response against the human papilloma virus-infected cells. It has been suggested that intralesional measles mumps rubella vaccine results in regression of warts via induction of immune system. #Intervention - DRUG : Measles-Mumps-Rubella Vaccine - MMR vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments. Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\\or a decrease in the total number of warts), and no response (no change in size and number of warts). - Other Names : - MMR - PROCEDURE : cryotherapy - patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions.Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\\or a decrease in the total number of warts), and no response (no change in size and number of warts).

#Eligibility Criteria: Inclusion Criteria: * Patients should have multiple common or plantar warts. * No concurrent systemic or topical treatment of warts Exclusion Criteria: * patients under 16 years. * Patients with fever or signs of any inflammation or infection. * Patients with other types of warts. * Patients with single warts. * Pregnancy. * Lactation. * Immunosuppression. * Patients who received any other treatments for their warts in the month before starting study. * Past history of asthma, allergic skin disorders, meningitis or convulsions. Sex : ALL Ages : - Minimum Age : 16 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT03183765

{ "NCT_ID" : "NCT01983592", "Brief_Title" : "An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy", "Official_title" : "An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy", "Conditions" : ["Fatigue", "Effects of Chemotherapy"], "Interventions" : ["Other: Unmedicated lactose/sucrose globule", "Other: Homeopathic medicine"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Fatigue is frequently identified as one of the most troublesome symptoms in cancer patients and there are very few conventional therapies which can address the symptom of fatigue in patients who are undergoing cancer treatment. This study will be testing whether the administration of a complementary therapy (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and whether this treatment can lessen the fatigue symptoms of adults. The study will also test whether the n-of-1 study design is feasible in this population. Detailed Description This is an n-of-1 pilot trial of individualized homeopathic treatment of fatigue in a single adult who is undergoing any type of chemotherapy administered intermittently (i.e. not continuously). The participant will have a homeopathic consultation within 3 days of a round of chemotherapy ('treatment period') and will be administered either verum or placebo according to a binary randomization allocation sequence unknown to both the clinician and participant. During the subsequent treatment period the participant will be given the other allocation (verum or placebo). The following pairs of allocations will also be randomized with treatment continuing for as long as the participant is undergoing chemotherapy treatment. #Intervention - OTHER : Homeopathic medicine - Intervention must begin within 5 days of chemotherapy cycle completion. Intervention will continue until the next cycle of chemotherapy. The initial consultation will involve a verbal interview between the homeopath and the participant. The practitioner will then choose a single homeopathic remedy that will focus on the reduction of fatigue. Only one homeopathic remedy and potency will be administered at a given time. The participant will be asked to take the study medication at least 30 minutes before or after taking other medications, food and strong smelling substances. - OTHER : Unmedicated lactose/sucrose globule

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with any type of cancer. Patient may have newly diagnosed, relapsed or a second malignant disease. * Receiving any type of cytotoxic chemotherapy with 6 or more cycles post study enrollment administered intermittently every two or three weeks with no planned radiation treatment. * Is experiencing fatigue due to the chemotherapy treatments. (or has a score of 2 or higher on the fatigue item of the Symptom Distress Scale) * Above 18 years. * Able to ingest medications in lactose/sucrose globule or liquid form. Exclusion Criteria: * Previous history of allergy to the homeopathic products. * Pregnant or lactating Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01983592

{ "NCT_ID" : "NCT00355472", "Brief_Title" : "Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL", "Official_title" : "Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)", "Conditions" : ["Adult T-Cell Leukemia and Lymphoma (ATL)", "Adult Peripheral T-Cell Lymphoma (PTCL)"], "Interventions" : ["Drug: KW-0761"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL). Detailed Description This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established. #Intervention - DRUG : KW-0761 - IV administration at 4 escalating dose levels.

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed diagnosis of a CCR4-positive ATL and PTCL that is any of the following: A. ATL (Adult T-Cell Leukemia-Lymphoma) * Seropositive for anti-Human T-lymphotrophic Virus type-I (HTLV-I) antibody; * Acute, Lymphoma, or Chronic phase with high-risk factors (within 14 days before the study entry); B. PTCL (Peripheral T-Cell Lymphoma) * Includes Mycosis Fungoides and Sezary Syndrome; 2: Relapsed to the latest standard chemotherapy; 3: Received at least one prior chemotherapy; 4: After 4 weeks from a prior therapy; 5: Have measurable disease; 6:Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; 7: Male or female, at least 20 years and not older than 70 years; 8: Signed written informed consent; 9: Stay in hospital for 4 weeks; 10: HBs antigen: negative, HBV-DNA: below the limit of quantification (within 14 days before the study entry); 11: Adequate bone marrow, hepatic and cardiac function including the followings: * Neutrophil count >= 1,500 /mm3, * Platelets >= 75,000 /mm3, * Hemoglobin >= 8.0 g/dL * Serum creatinine <= 1.5 x ULN; * Serum SGOT (AST) and SGPT (ALT) <= 2.5 x ULN (<= 5.0 x ULN if considered due to disease involvement in liver); * Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if considered due to disease involvement in liver) * Serum calcium <= 11.0 mg/dL * PaO2 >= 65 mmHg or SaO2 >= 90% * No clinically significant Electrocardiogram abnormality * Left Ventricular Ejection Fraction >= 50% [by ECHO or MUGA] Exclusion Criteria: * Co-existing active infection or any co-existing medical condition that may compromise the safety of patients during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results; * Active tuberculosis; * Prior stem cell transplantation; * Myocardial infarction (within 12 months prior to the study entry); * Concurrent acute or chronic hepatitis, or cirrhosis; * Anti-HCV: positive, Anti-HIV: positive * Concurrent active malignant disease; * Known allergic reaction to antibody therapy; * Concomitant treatment with systemic steroids; * Prior and Concurrent psychiatric disorder including dementia, epilepsy or any other CNS diseases; * Evidence of CNS metastasis at baseline; * Prior and Concurrent spinal cord disease; * Radiation therapy for bulky mass disease at the time of study entry or considered to require radiation therapy during the study; * Female patients who are pregnant or breast feeding; * Female patients of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards; * Treatment with any other investigational agent within the 4 months prior to study entry; * For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator. Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 69 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00355472

{ "NCT_ID" : "NCT03796819", "Brief_Title" : "Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma", "Official_title" : "Impact of Routine Lymphadenectomy on Prognosis of Patients Undergoing Curative Resection for Intrahepatic Cholangiocarcinoma", "Conditions" : ["Intrahepatic Cholangiocarcinoma"], "Interventions" : ["Procedure: lymphadenectomy"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional retrospective study have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains. Detailed Description Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver represents the best curative treatment option. However, the role of lymphadenectomy (LND) at the time of surgery remains controversial with some centers considering it standard while other surgeons perform LND only in select circumstances. The utilization of LND may not only vary among different institutions, but also by geographic region. Specifically, data from East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While several case series from Asia have noted that most centers do not regularly perform LND,other data from the West suggest that LND may be becoming more routine. Despite the lack of consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual recommends that the nodal basin be staged. Disease-specific staging for ICC was first introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated 8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to stage a patient with ICC. The previous multi-institutional retrospective study from the investigators have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains. #Intervention - PROCEDURE : lymphadenectomy - Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection

#Eligibility Criteria: Inclusion Criteria: * Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy * The tumor is limited in the liver with no distant metastasis, and the primary disease is resectable * Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found no nodal swelling or enlargement Exclusion Criteria: * The primary disease is unresectable with or without distant metastasis * The liver function or general condition of patients does not permit surgery * Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found obvious nodal swelling or enlargement, which indicates lymphadenectomy should be performed * Patients aged below >= 18 years than 65 would be excluded * Pregnant women would not be enrolled Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03796819

{ "NCT_ID" : "NCT03001882", "Brief_Title" : "An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)", "Official_title" : "An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)", "Conditions" : ["Non-Small Cell Lung Cancer"], "Interventions" : ["Biological: Nivolumab", "Biological: Ipilimumab"], "Location_Countries" : ["Netherlands", "Belgium", "Italy", "Germany", "United States", "France", "Spain", "Romania"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). #Intervention - BIOLOGICAL : Nivolumab - Specified dose on specified days - Other Names : - Opdivo, BMS-936558 - BIOLOGICAL : Ipilimumab - Specified dose on specified days - Other Names : - Yervoy, BMS-734016

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease * Measurable disease by CT or MRI * Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work Exclusion Criteria: * Participants with untreated central nervous system metastases * Participants with active, known or suspected autoimmune disease * Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03001882

{ "NCT_ID" : "NCT01295632", "Brief_Title" : "Safety and Tolerability of Different Dose Combinations of Ridaforolimus With MK-2206 or MK-0752 for Participants With Advanced Cancer (MK-8669-049)", "Official_title" : "Phase I Parallel Protocol of MK-8669 (Ridaforolimus) + MK-2206 and MK-8669 (Ridaforolimus) + MK-0752 Doublets (MK-MK) in Patients With Advanced Cancer", "Conditions" : ["Advanced Cancer"], "Interventions" : ["Drug: ridaforolimus", "Drug: MK-2206", "Drug: MK-0752"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a two part study of the drug MK-8669 (ridaforolimus) given with MK-2206 or MK-0752. In Part A of the study, the preliminary maximum tolerated dose (MTD) of the drug combinations will be found by giving sequentially higher doses of the study drugs. An expansion cohort of participants may be enrolled to confirm the MTD. New cohorts at other dose levels may be enrolled, depending on the rate of dose limiting toxicities (DLTs) in the planned cohorts. In Part B, an assessment of the efficacy of the drug combinations against selected advanced cancers will be made so that a recommended dose to be used in Phase 2 studies (RPTD) can be found. As of 19 July 2012 the MK-0752 arms of the study were fully enrolled and closed to further recruitment. As of 30 November 2012, no additional participants with prostate cancer will be enrolled. #Intervention - DRUG : ridaforolimus - 10 mg enteric-coated tablets, orally, starting dose 2 tablets and escalating to 4 tablets each day for 5 days per week. - Other Names : - MK-8669 - DRUG : MK-0752 - 300 mg capsule, orally, 6 capsules per dose, once each week. - DRUG : MK-2206 - Tablets (5 mg, 25 mg, and 200 mg) to equal starting dose of 90 mg and escalating to 200 mg per dose, orally, once each week.

#Eligibility Criteria: Inclusion Criteria: Part A of the Study: Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. Non Hodgkin Lymphoma (NHL) participants (in Part A only), must have histologically confirmed relapsed/refractory NHL. There is no limit on the number of prior treatment regimens. Part B of the Study: * Participant must have performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Participant must have adequate organ function. * Participants must be willing to use effective methods of contraception. * Participant is able to swallow capsules and has no surgical or anatomical condition that will preclude the participant from swallowing and absorbing oral medications on an ongoing basis. * Participant has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with Prostate-Specific Antigen (PSA) <1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician. * Participant has at least one measurable recurrent or metastatic lesion (if a solitary lesion, histological/cytological confirmation of its neoplastic nature is required) with the exception of prostate cancer participants which do not require measurable disease if participant has PSA level of >10 ng/mL. * Participant must agree to provide archival or newly-obtained tumor tissue sample. * Ridaforolimus + MK-2206 Treatment Arm: * Participant must have a histologically-confirmed prostate cancer that is refractory to hormone therapy and for which the participant received any number of prior treatment regimens (no longer recruiting as of 30 November 2012), OR * Participant must have a histologically-confirmed breast cancer for which the participant received any number of prior treatment regimens. Archival or fresh tissue must demonstrate a low RAS-gene signature and a high Ki67 index label if estrogen receptor (ER)+ * Ridaforolimus + MK-0752 Treatment Arm: * Participant must have a histologically-confirmed recurrent (either primary or secondary) glioblastoma multiforme with radiographic evidence of progression/recurrence of disease, and up to 2 prior treatment regimens for their recurrent disease, and no prior treatment with bevacizumab, OR * Participants must have a histologically-confirmed relapsed or refractory ovarian cancer for which the participant received no more than 2 prior treatment regiments which was either relapsed or refractory to the first line treatment. Exclusion Criteria: * Participant has had chemotherapy or radiotherapy within 4 weeks prior to study Day 1 (6 weeks for nitrosoureas, mitomycin C), biological therapy (excluding antibodies) within 2 weeks prior to study Day 1, or who has not recovered (<=Grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier. Luteinizing-hormone releasing hormone (LHRH) use by prostate cancer patients is permitted; participants with prostate cancer previously treated with flutamide or nilutamide require 4 week washout period and participants previously treated with bicalutamide require 6 week washout period before study drug administration. * Participant is currently participating or has participated in a study with an investigational compound or device within 28 days, or 5X half-life of the investigational compound (not including monoclonal antibodies), whichever is longer, of Day 1 of this study. * Participants with known symptomatic or progressing Central Nervous System (CNS) metastases and/or carcinomatous meningitis are excluded. However, participants with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids. * Participant has known hypersensitivity to the components of study drug or its analogs. * Participant has prior exposure to agents that have the same target as to the study drug. * Participant has significant or uncontrolled cardiovascular disease, including New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a myocardial infarction within the last 6 months. * Participant is a known diabetic participant who is poorly controlled at screening. * Participant has known psychiatric or substance abuse disorders that would interfere with compliance with study requirements. * Participant is, at the time of signing informed consent, a regular user (including 'recreational use') of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse. * Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. * Participant is known to be Human Immunodeficiency Virus (HIV)-positive. * Participant has active Hepatitis B or C. * Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions is eligible. * Participant has a requirement for concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for >= 2 weeks prior to first planned dose of study drug. * Participant has a requirement for concurrent treatment with medication(s) that strongly or moderate induce or inhibit cytochrome P450 (CYP3A). Participants should be off these medications >= 2 weeks prior to the first dose of study medication. * For participants with glioblastoma, dexamethasone should be discontinued at least 1 week prior to the first dose of study drugs. For participants on the Ridaforolimus + MK-0752 treatment arm: * Participant requires or anticipated to require concomitant therapy with enzyme-inducing antiepileptic therapy. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01295632

{ "NCT_ID" : "NCT00836186", "Brief_Title" : "Cytokine Expression During Radiation for Breast Cancer", "Official_title" : "Cytokine Expression During Radiation for Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Radiation: Radiation therapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To assess the magnitude and frequency of changes in chemo/cytokine expression in women receiving radiation treatment. To asses the impact of race/ethnicity on the magnitude and frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer. And finally to assess the interaction between radiation-induced chemo/cytokine expression changes, and race/ethnicity, with respect to normal tissue reactions to radiation and tumor-associated outcomes. Detailed Description It is well recognized that the diagnostic and therapeutic gains made in the management of breast cancer over the last 2 decades are not fully realized by all groups. African American women with breast cancer have greater risk of recurrence, shorter overall survival, shorter survival after relapse, worse toxicity and worse cosmetic outcome than their Caucasian counterparts. These differences in outcome persist even when controlling for age, and stage at presentation. Being similarly treated with modern breast conserving therapy (lumpectomy and adjuvant whole breast irradiation) at recognized centers of excellence does little to alleviate the disparities in outcomes. Controlling for socioeconomic factors decreases the severity of these disparities, but it does not completely explain them. Theories abound as to the cause of outcome inequality. Many of these theories take either a psychosocial, or biologic bent. One potential biologic cause may be chemokine and cytokine expression. Chemokines and cytokines (chemo/cytokines) are proteins and peptides used for cell signaling. Primarily secreted by T cells and macrophages, they influence cellular activation, differentiation, and function and act as mediators for inflammatory and immune responses. There has been substantial research linking some of these chemo/cytokines \[Tumor necrosis factor alpha (TNFα), platelet derived growth factor (PDGF), Transforming growth factor beta (TGFβ), interleukin (IL)-6,and IL-8\] to tumor promotion and progression. For example, TNFα has been linked to greater cell survival despite genomic injury which in turn leads to greater genetic alterations and malignant transformation. TNFα has been associated with breast cancer progression and metastases. Blocking the receptor for PDGF appears to decrease the metastatic potential of breast cancer cell lines. TGFβ inhibits T cell and B cell lymphocytes and natural killer cell cytotoxicity. This immuno-suppression has been shown to promote tumor progression in mammary cancer cells lines. The ability of TGFβ to promote tumor progression is so well recognized that it has become a therapeutic target by some researchers. Interferon gamma (IFNγ) has been shown to inhibit mammary cancer cell proliferation and angiogenesis in vitro and in vivo. Clinically, Lyon et al reported significantly higher circulating levels of TNFα, IL-6, and IL-8 in women with breast cancer compared to women with a negative breast biopsy. Additionally, researchers have directly correlated increased levels of IL-6 with the development and progression of breast cancer, and decreased overall survival (OAS). Conclusion: Expression of certain chemokines and cytokines is associated with development and progression of breast cancer. #Intervention - RADIATION : Radiation therapy - Patients will receive whole breast radiation therapy at a dose of 180-200 centigray (cGy) per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy.

#Eligibility Criteria: INCLUSION CRITERIA: * Patient must be 18 years or older * Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast any T, any N, M0 disease * Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved. * Patients must be registered such that radiation therapy begins within 10 weeks of last surgery * Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80 <= age <= 100 Karnofsky Performance Scale at time of consult * Women of all races and ethnic groups are eligible for this trial EXCLUSION CRITERIA: * Patients must not have received prior radiation therapy to the breast at any time for any reason * Patients with squamous carcinomas or sarcomas of the breast cancer are not eligible * Patients treated with a mastectomy are NOT eligible * Any patient with active local-regional disease prior to registration is not eligible * No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years * Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy * Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00836186

{ "NCT_ID" : "NCT04117750", "Brief_Title" : "Impact of Vitamin D Supplementation on Cardiometabolic Status and Androgen Profile in Polycystic Ovary Syndrome", "Official_title" : "Impact of Vitamin D Supplementation on the Cardiometabolic Status and Androgen Profile in Women With Polycystic Ovary Syndrome: Placebo-Controlled Clinical Trial", "Conditions" : ["Evaluations, Diagnostic Self", "Treatment Adherence"], "Interventions" : ["Dietary Supplement: cholecalciferol (vit D3)"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Polycystic ovary syndrome (PCOS) is a heterogeneous disorder of reproductive, endocrine and metabolic functions. Vitamin D has an influence on metabolic and reproductive functions. This study was designed to explore the levels of free 25 hydroxy cholecalciferol \[25(OH) D\] in PCOS patients. We also aimed to clarify the impact of vitamin D supplementation on cardiometabolic status, androgen profile and clinical features of PCOS. Detailed Description Background Polycystic ovarian syndrome (PCOS) is a heterogeneous disorder affecting 510% of women of reproductive age. It is a disorder that affects the reproductive, endocrine and metabolic functions and is the leading cause of chronic anovulation leading to infertility. PCOS is characterized by hyperandrogenism, chronic oligo or anovulation, and polycystic ovaries. Hyperandrogenism, in particular, is a hallmark feature of PCOS because it is strongly implicated in the genesis of the disorder; and is also associated with metabolic derangements that contribute to the underlying pathophysiology. Also, it is associated with cardiovascular risk factors including obesity, insulin resistance (IR), dyslipidemia, endothelial dysfunction, and metabolic syndrome. Vitamin D (VD) is a fat-soluble vitamin that is naturally present in very few foods and available as a dietary supplement. It is a steroid hormone with pleiotropic effects. In addition to the main effects of VD on bone and calcium metabolism, it has other roles in the body, including modulation of cell growth, neuromuscular and immune function, and reduction of inflammation. VD deficiency is now recognized as pandemic disease. Its prevalence varies according to geographic location, season, ethnicity and the standard laboratory value; of what is considered normal, deficient and insufficient. VD deficiency is a risk factor for hypertension, diabetes, and various cancers . Accumulating evidence suggests that VD deficiency might be a causal factor in the pathogenesis of IR and the metabolic syndrome in PCOS. Carotid intima-media thickness (CIMT) measured by ultrasound is a noninvasive, safe, low-cost, reproducible, and well-validated marker of preclinical atherosclerosis. PCOS is the most frequent endocrine disorder among women of reproductive age and VD deficiency is a key problem in PCOS patients conversely, the basic mechanisms underlying the favorable effects of vitamin D in PCOS are still obscure. Resolving this mechanism may provide insight into the pathophysiology of this syndrome. It can also offer a new therapeutic option for PCOS women. Thus, in the present study was designed to explore the levels of free 25 hydroxyvitamin D \[25(OH) D\] in PCOS patients. We also aimed to clarify the impact of vitamin D supplementation cardiometabolic status, androgen profile and clinical features of PCOS. Methods This placebo-controlled trial comprised 95 women with PCO recruited from Outpatient Clinics of the Endocrinology Unit of Internal Medicine and Obstetrics and Gynecology Departments, Faculty of Medicine, Zagazig University, Egypt and 50 healthy women matched to PCOS women as regard age and ethnic origin. The diagnosis of PCOS was based on the 2004 revised Rotterdam criteria .. All women underwent the menstrual history and thorough clinical examination. All patients were assessed at the study start on the third day of a spontaneous or progesterone-induced menstrual cycle. Anthropometric measures were estimated, including waist/hip ratio, height and weight then we calculated body mass index (BMI). We estimated the hirsutism score according to Ferriman and Gallwey. .Ovarian volume and antral follicular count (AFC) were evaluated by transvaginal ultrasound (TVS). PCOS patients were randomized divided to the intervention group (n=55) received vitamin D supplements (42,000 IU oral vitamin D per week and 500 mg calcium carbonate per day for 12-week), and non-intervention group (n=40) received 500 mg calcium carbonate per day for 12-week. The exclusion criteria for all women included a history of hyperandrogenic states (such as nonclassic congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, 21-hydroxylase deficiency, or hyperprolactinemia), DM, hypertension, liver, kidney, or thyroid diseases. In addition, subjects on non-steroidal anti-inflammatory drugs and multivitamin, as well as patients treated with hormone replacement therapy. At the start of the study, the participants were asked to maintain their usual diet and level of physical activity throughout the study period as well as not to receive any lipid-lowering medications and medications that might affect their reproductive physiology during the 12-week intervention. At baseline and at the endpoint of the 12 weeks of study, anthropometrical measurements were estimated as well as and blood samples were collected for biochemical analyses. Written informed consent was taken from all of the participants after explaining details and benefits as well as risks to them. The ethical committee of the Faculty of Medicine, Zagazig University approved our study protocol. 2.1. Sampling of blood Blood samples were drawn from all subjects during the early follicular phase of the menstrual cycles. One ml was collected into tubes containing fluoride for fasting plasma glucose (FPG). A second remaining part underwent immediate serum separation and was stored at -20 ◦C until analysis serum. calcium, phosphate, albumin were measured. Total cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides levels were determined using routine enzymatic methods (Spinreact, Girona, Spain). Low-density lipoprotein (LDL) cholesterol levels were calculated using the Friedewald formula. 2.2. Immunochemical assays: We measured prolactin, FSH, and LH levels via chemiluminescence immunoassays (CLIA) provided by (Immunospec Corporation, CA, USA). Serum high-sensitivity C-reactive protein (hs-CRP) concentrations were measured using high sensitivity enzyme-linked immunosorbent assays (ELISA) (Biosource, Nivelles, Belgium). We determined to fast insulin, FSH, LH, total and free testosterone, sex hormone-binding globulin (SHBG) levels using ELISA kits (DRG International, USA). We calculated insulin resistance (IR) with the homeostatic model assessment (HOMA-IR) index, which is defined as fasting serum insulin (FSI) value (µU/ml) × fasting plasma glucose value (mg/dl)/405. The B cell function was calculated using HOMA- B as (20× (fasting insulin µU/mL)/ (fasting glucose (mmol/l) - 3.5). 2.3.Determination of serum vitamin D levels Serum concentrations of 25(OH)-D were tested using enzyme-linked immunosorbent assay, \[Cat No. EQ 6411-9601, Euroimmun Medizinische Labordiagnostika AG, Germany\]. Current recommendations define VD deficiency as serum 25(OH)-D levels less than 20 ng/ml and VD insufficiency less than 30 ng/ml. 2.4. Carotid ultrasonography Carotid artery atherosclerosis was determined by one examiner for all patients across all six sites, using high-resolution B-mode ultrasound (M-Turbo®, SonoSite, Washington, Bothell, USA), according to American Society of Echocardiography protocol. #Intervention - DIETARY_SUPPLEMENT : cholecalciferol (vit D3) - 42,000 IU oral vitamin D per week and 500 mg calcium carbonate - Other Names : - calcium carbonate

#Eligibility Criteria: Inclusion Criteria: * women with PCO. The diagnosis of PCOS was based on the 2004 revised Rotterdam criteria * women must be able to swallow tablets Exclusion Criteria: * a history of hyperandrogenic states (such as nonclassic congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, 21-hydroxylase deficiency, or hyperprolactinemia) * DM3-hypertension * liver diseases * kidney diseases * Insulin-dependent diabetes * thyroid diseases. * women received non-steroidal anti-inflammatory drugs , multivitamins, and hormone replacement therapy. Sex : FEMALE Ages : - Minimum Age : 20 Years - Maximum Age : 33 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04117750

{ "NCT_ID" : "NCT00420160", "Brief_Title" : "Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?", "Official_title" : "Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?", "Conditions" : ["Lung Cancer", "Heart Disease", "COPD"], "Interventions" : ["Behavioral: Smoking cessation treatment plus health education", "Behavioral: Smoking cessation treatment plus moderate intensity exercise"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition. Detailed Description This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. A number of techniques will be used to increase compliance with the treatment program, thus more effectively isolating the effects of exercise. These include: (1) a two-week run-in period prior to randomization; (2) use of behavioral contracting prior to participant randomization; and (3) performance of all exercise on-site. Smoking cessation outcomes (continuous abstinence and point prevalence abstinence) will be verified by carbon monoxide and saliva cotinine. Physical activity will be evaluated by attendance at the supervised sessions. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition. #Intervention - BEHAVIORAL : Smoking cessation treatment plus moderate intensity exercise - BEHAVIORAL : Smoking cessation treatment plus health education

#Eligibility Criteria: Inclusion Criteria: * Healthy sedentary smokers (> 4 per day for at least one year) * Ages 18 <= age <= 65 * Must be able to give informed consent * Must live in the area for the next 3 months * Willing to use the nicotine patch to attempt smoking cessation * Must receive consent to participate from primary care physician Exclusion Criteria: * Cannot read or write fluently in the English language * Pregnancy or plans to attempt pregnancy * 60 minutes or more per week of moderate or vigorous physical activity * Smokes cigars, pipes, or uses smokeless tobacco at least once per week * Currently in a quit smoking program * Currently using NRT of any kind or using any other quit smoking method or treatment * Never had an adverse reaction to the nicotine patch resulting in discontinuation of use * Poor willingness or inability to comply with protocol requirements * An employee of the Centers for Behavioral and Preventive Medicine * Previous participant in Commit to Quit or Fit to Quit smoking cessation studies * Another member of the household is or has been enrolled in this study * Currently taking a medication that might impact heart rate response, including but not limited to: Acebutolol Atenolol Carvedilol Metoprolol Nadolol Pindolol Propranolol Timolol Medical problems: * Cardiac disease of any kind such as angina, a history of myocardial infarction or valve disease including mitral valve prolapse. Anyone with an interventional procedure such as a stent * Pain, discomfort (or other anginal equivalent) in the chest, neck, jaw, arms or other areas that may be due to ischemia * Cerebrovasular disease such as stroke or history of transient ischemic attacks * Peripheral vascular disease (such as claudication) * Diabetes (both Type I and II) * Chronic infectious disease (HIV, hepatitis) (hepatitis A is okay) * Liver disease * Cystic fibrosis (CF) * Chronic obstructive pulmonary disease (COPD) (see asthma and bronchitis under questionable) * Interstitial lung disease * Emphysema * Chronic Bronchitis * Orthopnea (difficulty breathing except in the upright position) or paroxysmal nocturnal dyspnea (sudden shortness of breath at night typically triggered by lying down) * Current diagnosis of Chronic Fatigue Syndrome * Current diagnosis of Fibromyalgia * Abnormal exercise stress test * Hypertension (anyone currently being followed and/or treated for hypertension) * Cancer treatment (other than skin cancer) within the past 6 months * Musculoskeletal problems such as osteoarthritis, gout, osteoporosis or back, hip or knee pain that can interfere with physical activity (i.e., walking at a brisk pace - about 3-mph) * Any other serious medical condition that might make exercise unsafe or unwise Psychiatric Problems * Hospitalization for a psychiatric disorder in the last 6 months * Currently suicidal or psychotic, (or suicidal/psychotic in last 6 months) * Self-report of more than three alcoholic drinks per day on 5 or more days; 5 or more alcoholic drinks on 3 or more days * Taking these specific medications for psychiatric problems: Mood stabilizer (Lithium, Depakote, Neurontin), Antipsychotics (Haldol, Clozaril, Risperdal) * Must be on other current psychiatric medications for at least three months REQUIRES MD CONSENT FOR THE SPECIFIC CONDITION * Lightheadedness, dizziness, vertigo, or fainting * Last electrocardiogram (EKG) performed was abnormal * Anemia * Previous ETT for medical reason with normal results * Irregular heart beats or palpitations in the past two years * Heart murmurs in the past two years - the person will need physician's consent and an echocardiogram showing no evidence of significant heart disease Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT00420160

{ "NCT_ID" : "NCT00268671", "Brief_Title" : "Docetaxel in Squamous Cell Carcinoma of the Head and Neck (TAX + Cisplatin in SCCHN)", "Official_title" : "Phase I/II Trial of Weekly Docetaxel and Cisplatin for Locoregional Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)", "Conditions" : ["Head and Neck Neoplasms"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Study Objectives: * To determine the MTD (maximal tolerated dose) and recommended dose of a weekly docetaxel and cisplatin combination regimen for locoregional recurrent/metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) * To determine the response rate of the recommended dose * To determine the safety and tolerability of the recommended dose #Intervention - DRUG : Docetaxel

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed (of original primary tumor) locoregional recurrent and/or metastatic following prior radiotherapy and/or surgery and not amenable to further curative local therapy for SCCHN * Measurable disease as defined by at least the longest diameter measured as 20 mm by conventional CT or 10 mm by spiral CT. Physical measurements are allowed if longest diameter is 20 mm by caliper measurements. * ECOG performance status 0 <= age <= 2 * Adequate bone marrow and hepatic function as evidenced by the following: * Hematology (Bone marrow): * Neutrophils >= 1.50 x 10^9/L * Platelets >= 100 x 10^9/L * Hemoglobin >= 10 g/dL * Hepatic function: * AST and/or ALT: < 2X ULN (Upper Limit of Normal) * Bilirubin < 1X ULN * Adequate renal function with calculated or measured glomerular filtration rate of > 60 ml/min calculated by the Cockcroft- Gault method * No severe intercurrent illness or other serious illness or medical conditions including but not limited to: * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry. * Active uncontrolled infection * Active peptic ulcer * Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry * No prior chemotherapy for recurrent/advanced SCCHN with platinum or taxane regimen (primary radiosensitizing platinum allowed). * No other diagnosed malignancy other than basal cell carcinoma of the skin or cervix carcinoma in situ Exclusion Criteria: * Prior therapy with taxanes either adjuvant, neoadjuvant, concurrent or in advanced stage disease * Prior chemotherapy for locoregional recurrent/metastatic SCCHN with palliative intent * Contraindications from * the medical history (i.e. known hepatitis, HIV) and physical exam * laboratory tests (hematology, biochemistry) * 12-lead electrocardiogram * blood pressure and pulse * Pregnancy * Breast-feeding * Treatment with any investigational product in the last 4 weeks before study entry * Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs * History of hypersensitivity to the study drug(s) or to drugs with a similar chemical structure * Impaired hepatic function, as shown by bilirubin greater than upper limits of normal and/or AST greater than 2 times upper limits of normal * Impaired renal function, as shown by measured or calculated creatinine clearance of < 60 ml/min or absolute creatinine level > 1.5 upper limit of normal Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00268671

{ "NCT_ID" : "NCT01947166", "Brief_Title" : "Pancreatic Resection, Malnutrition and Readmission", "Official_title" : "Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention", "Conditions" : ["Pancreatic Cancer", "Malnutrition"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants. #Intervention - DIETARY_SUPPLEMENT : Nestle Impact Advanced Recovery nutritional supplement - Before Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days (15 servings total) on postoperative day minus 5 through postoperative day 1 in addition to normal diet. After Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days on postoperative day 2 through postoperative day 6.

#Eligibility Criteria: Inclusion Criteria: * Adult patients (>18 years)at Duke Cancer Center * Malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (Whipple) * Able to read and speak English. Exclusion Criteria: * Patients receiving preoperative enteral nutrition * Inability to tolerate preoperative oral intake Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01947166

{ "NCT_ID" : "NCT04552405", "Brief_Title" : "Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study", "Official_title" : "Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study", "Conditions" : ["Familial Adenomatous Polyposis (FAP)"], "Interventions" : ["Dietary Supplement: Anti-inflammatory Diet"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study Detailed Description a prospective pilot study #Intervention - DIETARY_SUPPLEMENT : Anti-inflammatory Diet - FAP individuals followed for 3 months a low-inflammatory diet

#Eligibility Criteria: Inclusion Criteria: * FAP patients carrying mutations in APC gene, submitted to prophylactic total colectomy/IRA (with rectum preservation) and that participate to the regular endoscopic surveillance program at IRCCS-INT. Exclusion Criteria: * FAP patients taking NSAIDs and/or Omega 3 * Patients who carried MUTYH germline mutations or had no APC mutation found. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04552405

{ "NCT_ID" : "NCT01531894", "Brief_Title" : "Continuation Study of the Oral AKT Inhibitor GSK2110183", "Official_title" : "An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies", "Conditions" : ["Cancer"], "Interventions" : ["Drug: GSK2110183 (afuresertib)"], "Location_Countries" : ["Ireland", "Korea, Republic of", "Australia", "United States", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study. Subjects were enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study. Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location. #Intervention - DRUG : GSK2110183 (afuresertib) - Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning. - Other Names : - ASB183

#Eligibility Criteria: Inclusion Criteria: * Has provided signed informed consent for this study. * Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK. * Currently benefitting from continued treatment and have an acceptable safety profile with GSK2110183 as determined by the investigator following previous treatment with GSK2110183 either as monotherapy or as part of a combination treatment regimen. * Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. * Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 16 weeks after the last dose of GSK2110183. * Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 weeks after the last dose of GSK2110183. * Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study. * Maintain a performance status score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale * Subjects with Type II diabetes are only allowed if their HbA1C is less than 8 percent at study entry. * Have adequate organ system function Exclusion Criteria: * Permanent discontinuation of GSK2110183 in the parent study due to toxicity or disease progression. * Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol. * Local access to commercially available GSK2110183. * Current use of a prohibitive medication(s) * Current use of anticoagulants * Any unresolved toxicity greater than Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study. * History of HIV infection. * Peripheral neuropathy greater than Grade 1 * History of hepatitis B or C infection (subjects with evidence of cleared hepatitis B are permitted). * Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, hepatic, renal, metabolic or cardiac disease). * QTcF interval greater than 500 msecs at the time of transition to this study. * Other clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. * Evidence of current Class II, III, or IV heart failure as defined by the New York Heart Association [NYHA, 1994] functional classification system at the time of transition to this study. * Symptomatic or untreated leptomeningeal, CNS or brain metastases or spinal cord compression at the time of transition to this study. * Lactating female or female who becomes pregnant prior to transition to this study. * Previously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilled * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01531894

{ "NCT_ID" : "NCT02115139", "Brief_Title" : "GEM STUDY: Radiation And Yervoy in Patients With Melanoma and Brain Metastases", "Official_title" : "A Multicenter, Single Arm, Phase 2 Clinical Study on the Combination of Radiation Therapy and Ipilimumab, for the Treatment of Patients With Melanoma and Brain Metastases", "Conditions" : ["Melanoma", "Brain Metastases"], "Interventions" : ["Drug: Ipilimumab"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Ipilimumab adds a clinical benefit to radiation therapy in patients with melanoma metastatic to the brain. Melanoma is the third most common cancer causing brain metastases, after cancers of the lung and breast, which appears to reflect the relative propensity of melanoma to metastasize to the central nervous system (CNS). Brain metastases are responsible for 20 to 54 percent of deaths in patients with melanoma, and among those with documented brain metastases, these lesions contribute to death in up to 95 percent of cases, with an estimated median overall survival ranging between 1.8 and 10.5 months, depending upon other prognostic factors. Ipilimumab is an anti-Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) monoclonal antibody that has demonstrated a clinically relevant and statistically significant improvement in overall survival, either alone (second line) or in combination with dacarbazine (DTIC) in 1st line. Ipilimumab has shown activity against brain metastases. According to the European Medicines Agency (EMA) approved label for Yervoy®, the use of glucocorticoids at baseline (commonly prescribed when brain metastases are diagnosed) should be avoided before the administration of ipilimumab. Data show that the use of even high doses of glucocorticoids for the management of immune-related adverse events do not decrease the efficacy of Yervoy®. There is no documented experience on the efficacy of Yervoy® when given concomitantly with radiation therapy and glucocorticoids. In experimental models, radiation therapy is synergistic to anti-Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) strategies (abscopal effect). There are no published results from clinical trials on the interaction between radiation therapy and ipilimumab. #Intervention - DRUG : Ipilimumab - Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles - Other Names : - Experimental

#Eligibility Criteria: Inclusion Criteria: * Willing and able to give written informed consent. * Histologic diagnosis of melanoma. * First episode of radiological evidence of brain metastases * Be over the age of 18 years * Radiation Therapy Oncology Group-recursive partitioning analysis (RTOG-RPA) class 2 * Karnofsky performance status (PS) more than 70% * Barthel Index of Activities of Daily Living more than 10 * Measurable disease (mWHO criteria). * Adequate organ function as determine by the following criteria: * White blood count (WBC) more or equal to 2000/ microliter (uL) * Absolute neutrophil count (ANC) more than 1.5 x 109/L. * Platelet count more than 75 x 109/L. * Hemoglobin more than 9 g/dL. If the patient received a red blood count (RBC) transfusion, the required value of hemoglobin should be met at least 1 week after the most recent transfusion. * Serum creatinine less or equal to 2.0 x upper limit of normal (ULN). * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) less or equal to 2.5 x ULN for patients without liver metastasis, or less or equal to 5 times for liver metastases. * Total bilirubin less or equal 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL) * Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 26 weeks after ipilimumab is stopped Exclusion Criteria: * Patients with melanoma and brain metastases with any of the following disease-specific characteristics: * Documented evidence of prior progression of melanoma to an ipilimumab-containing regimen (i.e. received at least 2 doses of ipilimumab for either advanced disease or in the adjuvant setting and the disease progressed/relapsed (according to mWHO criteria) within 24 weeks since the first dose of ipilimumab) * Prior radiation therapy to the brain * Other prior antineoplastic therapies for brain metastases. * Patients with cerebral metastases as the only location of the disease, for which local therapy (neurosurgery, radiosurgery) could achieve a disease-free status * Patients with a rapid clinical deterioration, or with risk of herniation, or who require unstable ascending dosing of supportive medication in the last week -including anti-convulsivants, steroids and analgesics-, or who require dexamethasone more than 16 mg/d (or other glucocorticoid at an equipotent dose), or with a high lactate dehydrogenase (LDH) more than 2 x ULN. * Any other malignancy form which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, or incidental prostate cancer. * Uncontrolled diabetes mellitus (HbA1c more than 9 %) * Autoimmune disease other than vitiligo or past thyroiditis under substitutive hormone therapy: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). * Other chronic intestinal diseases associated with diarrhea. * Active infection or other serious illness or medical condition. * Known active or chronic infection with HIV, Hepatitis B, or Hepatitis C. * Concomitant therapy with any of the following: interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used for the management of non-cancer related illnesses), either concomitantly or during the last 30 days prior to the beginning of the treatment. * Any experimental therapy administered in the past 30 days prior to the beginning of the treatment. * Any non-oncology vaccine therapy used for the prevention of infectious diseases (for up to 4 weeks prior to or after any dose of blinded study drug) (see definitions in protocol text) * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness. * Any other general, medical or psychological conditions which in the opinion of the investigator will make the administration of ipilimumab hazardous, or that would preclude appropriate informed consent or compliance with the protocol, or obscure the interpretation of eventual adverse events (AEs). Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02115139

{ "NCT_ID" : "NCT01530581", "Brief_Title" : "Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation", "Official_title" : "A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies", "Conditions" : ["Transplantation for Hematologic Malignancies"], "Interventions" : ["Procedure: G-PB Transplant", "Procedure: G-BM Transplant"], "Location_Countries" : ["Saudi Arabia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for Haematologic Malignancies. #Intervention - PROCEDURE : G-PB Transplant - G-PB Transplant - PROCEDURE : G-BM Transplant - G-BM Transplant

#Eligibility Criteria: Inclusion Criteria: * Recipient must 1. Be between the ages of 16 and 65 years 2. Have one of the following hematologic malignancies: * Acute myeloid leukemia (de novo, secondary or therapy related) in untreated 1st relapse or in remission or with evidence of molecular relapse but blasts less than 5% * Chronic myeloid leukemia in chronic or accelerated phase (de novo or therapy related) * Myelodysplasia (de novo or therapy related) * Other hematologic malignancy (de novo or therapy related) including but not limited to: ALL (CR 1, CR2 or CR3), CLL, non-Hodgkin's lymphoma, Hodgkin's lymphoma 3. Must be receiving a myeloablative conditioning regimen of busulfan and cyclophosphamide or TBI and cyclophosphamide or other myeloablative regimen approved by the Clinical Study Chair. (Regimens containing ATG are not allowed.) 4. Have an HLA-identical sibling donor 5. Meet the transplant centre's criteria for myeloablative allogeneic transplantation* 6. Have an ECOG performance status of 0, 1 or 2 7. Have given signed informed consent Donor must * Be 18 years or older. (Upper age limit is at the discretion of the transplant physician at the collection centre.) * Be able to undergo general anesthesia and BM harvest or peripheral blood collection as per assessment by a transplant physician. (If an anesthetist assesses a donor after randomization and determines the donor should not undergo general anesthesia, then the donor and recipient will be withdrawn from the study.) * Be a sibling of the recipient * Be a 6/6 HLA match of the recipient. HLA typing is by serologic or DNA methodology for A and B and by DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution) * Have given signed informed consent Exclusion Criteria Recipient * The recipient is HIV antibody positive Donor * The donor is unable to undergo general anesthesia, bone marrow harvest or peripheral blood collection * The donor is pregnant or breastfeeding at the time of progenitor cell collection * The donor has a history of malignant disease within the last 5 years or current malignancy other than non-melanomatous in situ skin carcinoma or cervical carcinoma in situ * The donor is HIV antibody positive * The donor has a known sensitivity to E. coli-derived products * The donor and recipient are identical twins Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT01530581

{ "NCT_ID" : "NCT01579357", "Brief_Title" : "Pharmacokinetics and Metabolic Activation of Capecitabine", "Official_title" : "Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab", "Conditions" : ["Metastatic Colorectal Cancer"], "Interventions" : ["Other: blood samples"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt). #Intervention - OTHER : blood samples - Draw blood samples in week 1 (day 1 and day 5), in week 4 (day 1 and day 5) and in week 7 (day 1 and day 5). day 1: pre dose, 30,60,90,120,150,180,240,300 and 360min day 5: pre dose, 30,60,90,120min

#Eligibility Criteria: Inclusion Criteria selected: * signed written informed consent * male or female > 18 years * K-ras wild type adenocarcinoma of the colon or rectum * metastatic colorectal carcinoma * ECOG <= 2 Exclusion Criteria selected: * brain metastasis * previous chemotherapy * stage 3 or 4 heart failure * uncontrolled angina * pregnancy or lactation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01579357

{ "NCT_ID" : "NCT00577876", "Brief_Title" : "Assessment of the Functional Significance of Accessory Pudendal Arteries", "Official_title" : "Assessment of the Functional Significance of Accessory Pudendal Arteries", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Procedure: Trimix Injection with Doppler Ultrasound"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary For patients with Prostate Cancer advances in medical technology have enabled us to identify 'accessory' (additional) pudendal arteries (called APA) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). APAs running near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These arteries are preserved more than 80% of the time, depending on their size and location.With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied. Detailed Description Overall, approximately 50% of patients become impotent (inability to achieve or maintain an erect penis; also called erectile dysfunction) after radical prostatectomy (removal of the prostate). It is already known that postoperative (after surgery) erectile dysfunction does not depend solely on the preservation of the nerves going to the penis, but also to the preservation of the arteries bringing blood to the penis. Although, the presence and frequency of APAs have been studied, and the ability to preserve them has also been noted, we still do not know how much these arteries contribute to a male's erection. With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied. While there is no immediate benefit to you for participating in the study, these findings will further help our understanding of APA's and the importance in preserving them during surgery. The primary aim of this study is to determine the proportion of men with APAs for whom APAs contribute to penile blood flow. The secondary aim is to describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the APA. #Intervention - PROCEDURE : Trimix Injection with Doppler Ultrasound - In case a large APA was identified, it will be dissected following the usual technique. Upon completion of the dissection, patients will have intracavernosal injection of 10 units (0.1 ml) of a Trimix administered (PGE1 10 mcg/ml, papaverine hydrochloride 30 mg/mL and phentolamine mesylate 1mg/mL. Once the patient achieves a pharmacologic erection, the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion.

#Eligibility Criteria: Inclusion Criteria: * They have selected a LRP, with or without robotic assistance, by Jonathan Colelman, MD, Bertrand Guillonneau, MD, Vincent Laudone, MD, Raul Parra, MD, or Karim Touijer MD for definitive treatment of their prostate cancer after a full discussion of treatment options. Exclusion Criteria: * Patients undergoing Open Radical Prostatectomy * Patients with prior history of insulin dependent diabetes mellitus * Patient who have received prior radiation therapy to the pelvis or prostate * Patients requiring anticoagulation postoperatively * Known allergy to Phenylephrine, Alprostadil, Papaverine or Phentolamine * Patients whose systolic blood pressure is below 90 mmHg at the time of evaluation despite routine measures taken by the anesthesiologist at his best criteria. * Patients with labile hypertension or history of prior priapism * Patients with penile scarring or penile prosthesis * Patients with an International Index of Erectile Function score < 24 Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00577876

{ "NCT_ID" : "NCT02065154", "Brief_Title" : "Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis", "Official_title" : "Phase II Clinical Trial of the Use of Post-Transplant Cyclophosphamide for Graft Versus Host Disease (GvHD) Prophylaxis Following Matched Unrelated Donor (MUD) and Mismatched Unrelated Donor (MMUD)Hematopoietic Stem Cell Transplant (HSCT)", "Conditions" : ["Leukemia", "Lymphoma", "Myelodysplastic Syndrome", "Myelofibrosis", "Severe Aplastic Anemia", "Allogeneic Transplant"], "Interventions" : ["Drug: Cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The primary objective is to determine the incidence of grade II-IV acute GVHD following Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation. Disease recurrence and time to recurrence in patients receiving post-transplant cyclophosphamide compared to historical control without post-transplant cyclophosphamide (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset, severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as observation of Immune Reconstitution over time. Detailed Description he main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The primary objective is to determine the incidence of grade II-IV acute GVHD following Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation. Disease recurrence and time to recurrence in patients receiving post-transplant cyclophosphamide compared to historical control without post-transplant cyclophosphamide (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset, severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as observation of Immune Reconstitution over time. #Intervention - DRUG : Cyclophosphamide - Other Names : - Cytoxan

#Eligibility Criteria: Inclusion Criteria: * Disease Criteria: patients must meet diagnostic criteria of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), myelodysplastic syndrome (MDS), myelofibrosis, or severe aplastic anemia. Patients will be allowed on study if they are deemed eligible for allo HCT regardless of remission status. * Age Criteria: 19 <= age <= 65 in age. * Organ Function Criteria: All organ function testing should be done within 28 days of study registration. * Cardiac: Left ventricular ejection fraction (LVEF) >= 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram. * Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) >= 50% predicted, DLCO (diffusing capacity of the lung for carbon monoxide) (corrected for hemoglobin) >= 50% of predicted. * Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl=(140-age) x weight(kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) * Hepatic: * Serum bilirubin 1.5 upper limit of normal (ULN) * Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN * Alkaline phosphatase 2.5 ULN * Performance status: Karnofsky >= 70%., * Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study. * Patient has a suitable and willing HLA-8/8 matched or 6/8 mismatched (at one allele) unrelated donor identified. Exclusion Criteria: * Non-compliant to medications. * No appropriate caregivers identified. * HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive * Uncontrolled medical or psychiatric disorders. * Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration. * Active central nervous system (CNS) leukemia. * Preceding allogeneic HSCT. * Pregnancy or Breastfeeding. Sex : ALL Ages : - Minimum Age : 19 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02065154