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Study Objectives The study hypothesis is that the addition of Mycograb to docetaxel will improve outcome in advanced carcinoma of the breast. Conditions: Cancer of the Breast Intervention / Treatment: DRUG: Mycograb, Docetaxel Location: Poland, Serbia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Patients must be female between the ages of 18 to 70 years old. 2. Patients must have histologically or clinically confirmed metastatic and/or recurrent breast cancer amenable to treatment with docetaxel. 3. Patients must have presence of at least one uni-dimensional measurable lesion with minimal lesion size \> 20 mm at the largest diameter. 4. Patients may have had one previous chemotherapy regimen and must not have received prior chemotherapy with docetaxel. 5. Patients must have been off all hormonal therapy for at least 2 weeks prior to initiation of therapy. 6. Patients must have been off all chemotherapy or radiotherapy regimens for at least 4 weeks prior to initiation of chemotherapy. 7. Patients must have a life expectancy of at least 6 months. 8. Patients must have a ECOG status of 0, 1 or 2. 9. Patients must be willing to complete all procedures and visits as outlined in the protocol. 10. Patients must sign an informed consent form. 11. Patients must have negative blood test for HIV and hepatitis B and C. 12. Female patients of child bearing potential should use an effective method of contraception. Exclusion Criteria: 1. Patients with brain or meningeal metastases. 2. Patients whose only measurable lesion is in the bone. 3. Patients with clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, hematologic, metabolic or any other condition or laboratory abnormality that in the opinion of the investigator makes the patient unsuitable for participation in the study. 4. Patients with history of seizure disorder. 5. Patients who have received treatment with any other investigational drug within the preceding one month. 6. Patients who are pregnant or breast feeding.

Study Objectives Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This trial will determine the maximum tolerated dose and the efficacy of this combination administered weekly in patients with platinum -resistant ovarian cancer. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Hycamptin, DRUG: Gemcitabine Location: Greece Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed ovarian adenocarcinoma * Patients had to have received a front-line, platinum- based chemotherapy regimen * Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer. This category also will include patients with disease progression within six months of completing the most recent platinum-based chemotherapy * Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca 125 * A \>= 4 weeks interval between their last chemotherapy regimen and the start of study treatment * Age \> 18 years old * Performance status (WHO) 0-2 * Life expectancy of at least three months * Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3) * Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2 mg/dl) * Informed consent Exclusion Criteria: * Pregnant or nursing * Psychiatric illness or social situation that would preclude study compliance * Other concurrent uncontrolled illness * Other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Study Objectives Natural killer (NK) cells are leukocytes of the innate immune system and play a central role in the control of cancer metastases. NK cells and other innate immune cells often do not function well in patients with cancer and are also profoundly suppressed after cancer surgery. Dr. Auer's Lab and others have shown that NK cells are critically important in the clearance of tumor metastases and that their impairment can be recovered with immune therapy augmenting the innate immune system. Several studies suggest that cancer patients have depressed NK cell cytotoxicity as compared to healthy controls but that following resection of the cancer, NK cell cytotoxicity returns to normal levels. In this observational study, the investigators will measure NK cell cytotoxicity by the gold standard method (51Cr, a chromium51 release assay) and by a new interferon-ɣ (IFN-ɣ) based assay (NK-Vue™) in healthy humans and colorectal cancer (CRC) surgery patients seen a The Ottawa Hospital. The results of this study will determine if the NK-Vue™ is able to discriminate between healthy human volunteers and newly diagnosed cancer patients and is sufficiently sensitive to detect transient NK cell suppression immediately following surgery. Conditions: Colorectal Cancer, Surgery, Perioperative Care Intervention / Treatment: OTHER: Natural Killer Cell Activity Assay Location: Canada Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Subjects who have had a recent diagnosis of cancer (any stage) and will be undergoing surgery (cancer group) * Subjects who are being seen by their physician for other reasons, or healthy volunteers (control group) * Subjects who provide informed consent to participate in the trial * Subjects \>40 years of age Exclusion Criteria:

Study Objectives The investigators propose to carry out a prospective analysis of physical impact, psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of localized prostate cancer with an indication of curative radiotherapy. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . The quality of life of patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate in this elderly population and will allow an answer within 2 years to the problem raised in clinical practice. Conditions: Prostate Cancer Intervention / Treatment: OTHER: geriatric assessment and quality of life, RADIATION: Radiotherapy Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Man with a histologically proven prostate cancer 2. Indication of a curative intent radiotherapy 3. Age ≥ 75 years 4. Patient who signed an informed consent Exclusion Criteria: 1. Patient with metastatic prostate cancer 2. Patient unable to submit to monitoring of the protocol for social, geographical or family reasons 3. A person who is not affiliated to a social security scheme or of such a scheme 4. Patient under trusteeship

Study Objectives Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib. Conditions: Refractory Low-grade Gliomas, Recurrent Low-grade Gliomas Intervention / Treatment: DRUG: Nilotinib, DRUG: Vinblastine Location: Netherlands, Austria, Spain, France, Switzerland, United Kingdom, Denmark, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Written informed consent signed by the patient, or parents or legal representative and assent of the minor child. 2. Age: 6 months to \< 21 years of age at time of study entry 3. Histologically confirmed low-grade glioma in non-NF1 patients (no further biopsy is needed at study entry). For patients with NF1 and optic pathway glioma, no biopsy is required to confirm the radiological diagnosis of the low grade glioma. 4. Relapse or refractory tumor after at least one first-line therapy, not taking into account surgery only. 5. Evaluable Disease on morphologic MRI 6. Karnofsky performance status score \>=70% for patients \>12 years of age, or Lansky score \>=70% for patients \<=12 years of age, including patients with motor paresis due to disease. 7. Administration of stable dose of steroids for at least one week 8. Life expectancy \>= 3 months. 9. Adequate organ function: * Adequate hematopoietic function: neutrophils ³1.0 x 109/L, platelets ³100 x 109/L; hemoglobin ³8 g/dL * Adequate renal function: serum creatinine \< 1.5 x ULN for age In others cases where serum creatinine \>1.5 ULN according to age, Glomerular filtration rate or creatinine clearance has to be \>70 mL/min/1.73 m2 or \>70% of the expected value * Adequate electrolytes levels: potassium, magnesium, phosphor, total calcium Lower Limit of Normal (LLN) * Adequate hepatic function: total bilirubin \<=1.5 x ULN; AST and ALT \<=2.5 x ULN. * Absence of peripheral neuropathy \>= grade 2 (Common Toxicity Criteria Adverse Event, NCI CTCAE v4.0) * Adequate cardiac function: Shortening Fraction (SF) \>= 28% (35% for children \<3 years) and Left Ventricular Ejection Fraction (LVEF) \>= 50% at baseline, as determined by echocardiography Absence of QTc prolongation (QTc \> 450 msec on baseline ECG, using the QTcF formula) or other clinically significant ventricular or atrial arrhythmia 10. Wash-out period of at least * 3 weeks in case of preliminary chemotherapy, * 6 weeks in case of nitrosourea-containing chemotherapy, * 2 weeks in the case of treatment with vincristine only * 6 weeks in case of radiation therapy 11. Possibility of receiving the therapeutic schedule as indicated in the protocol 12. Patients with reproductive potential must use effective contraception during their treatment and for up to 90 days after the last dose. Females with reproductive potential must have a negative pregnancy test \<= 7 days before starting Nilotinib and/or Vinblastine. 13. Patients already treated with one of the two drugs can be enrolled in the trial provided that rechallenging them with the same drug could be considered acceptable Exclusion Criteria: 1. Concomitant anti-tumor treatment 2. Not recovered to \<Grade 2 from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy 3. Known intolerance or hypersensitivity to Vinblastine 4. Existence of another severe systemic disease 5. Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines, 6. Any concurrent illness which in the opinion of the investigator may interfere with the treatment and evaluation of the patient 7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib. 8. Simultaneous treatment with strong cytochromes P450 CYP3A4 inhibitors (e.g. antiepileptic drugs, see complete list in the Appendix 5). 9. Simultaneous treatment with antiarrythmic drugs and other drugs known to prolong QT interval (cloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin, bepridil, cisapride and pimozide). A list of QT prolonging compounds can be found at http://www.azcert.org/medical-pros/druglists/drug-lists.cfm (Appendix 6) 10. Impaired cardiac function including any one of the following: * Clinically significant resting brachycardia (\<50 beats per minute). * QTc \> 450 msec on baseline ECG. If QTc \>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. * Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension). * History of or presence of clinically significant ventricular or atrial tachyarrhythmias (including congenital long QT syndrome or a known family history of congenital long QT syndrome)

Study Objectives RATIONALE: Prostatectomy may be an effective treatment for prostate cancer that has not responded to radiation therapy. PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy. Conditions: Prostate Cancer Intervention / Treatment: PROCEDURE: conventional surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Histologically proven recurrent or persistent prostate cancer * Prostate-specific antigen (PSA) no greater than 20 ng/mL * Must have been previously treated with at least 60 cGy of external beam radiotherapy or brachytherapy for clinical stages T1-2NXM0 with PSA no greater than 30 ng/mL * No metastatic disease at time of biopsy PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * CALGB (Zubrod) 0-1 Life expectancy: * At least 5-10 years Other: * No other "currently Temporarily closed" malignancy except nonmelanoma skin cancer * Patients are not considered to have a "currently Temporarily closed" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Endocrine therapy: * At least 3 months since prior adjuvant hormonal therapy Radiotherapy: * See Disease Characteristics * At least 18 months since prior external beam or interstitial radiotherapy

Study Objectives The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen. Conditions: Leukemia, Lymphoma, Myeloma Intervention / Treatment: DRUG: Busulfan, DRUG: Fludarabine, DRUG: Campath, PROCEDURE: Stem Cell Transplant Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Phase I portion: * Relapsed or refractory acute myelogenous or lymphoid leukemia. * Chronic myelogenous leukemia in accelerated phase or blast-crisis. * Recurrent or refractory malignant lymphoma or Hodgkin's disease * Recurrent or refractory multiple myeloma. * Chronic lymphocytic leukemia, relapsed or with poor prognostic features. * Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation * Myelodysplastic syndromes with more than 5% blasts. Phase II portion: * AML with active disease or beyond CR2. * MDS with more than 5% blasts. Exclusion Criteria: * Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.

Study Objectives RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against non-small cell lung cancer. PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and bronchial disease. Conditions: Lung Cancer Intervention / Treatment: DRUG: porfimer sodium, PROCEDURE: bronchoscopy Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Patients that have a diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease receiving PDT treatment. Exclusion Criteria: * Patients that have undergone PDT, chemotherapy or radiation therapy within the past 3 months will not be considered for enrollment. * Patients taking antioxidant therapy will be excluded from enrollment due to potential interaction with the potential oxidative mechanism of action of Photofrin®. These antioxidants would include beta-carotene, lutein, Lycopene, Selenium, Vitamin A, Vitamin C, Vitamin E.

Study Objectives This pilot clinical trial studies an electronic monitoring device of patient-reported outcomes (PROs) and function in improving patient-centered care in patients with gastrointestinal cancer undergoing surgery. Electronic monitoring is a technology-based way of asking patients about the quality of life, symptoms, and activity using online surveys and an activity tracking watch may make it easier for patients to tell their doctors and nurses about any issues before and after surgery. Electronic systems of assessing PROs may increase the depth and accuracy of available clinical data, save administrative time, prompt early intervention that improves the patient experience, foster patient-provider communication, improve patient safety, and enhance the consistency of data collection across multiple sites. Conditions: Stage I Adult Liver Cancer, Stage I Colorectal Cancer, Stage IA Gastric Cancer, Stage IA Pancreatic Cancer, Stage IB Gastric Cancer, Stage IB Pancreatic Cancer, Stage II Adult Liver Cancer, Stage IIA Colorectal Cancer, Stage IIA Gastric Cancer, Stage IIA Pancreatic Cancer, Stage IIB Colorectal Cancer, Stage IIB Gastric Cancer, Stage IIB Pancreatic Cancer, Stage IIC Colorectal Cancer, Stage III Pancreatic Cancer, Stage IIIA Adult Liver Cancer, Stage IIIA Colorectal Cancer, Stage IIIA Gastric Cancer, Stage IIIB Adult Liver Cancer, Stage IIIB Colorectal Cancer, Stage IIIB Gastric Cancer, Stage IIIC Adult Liver Cancer, Stage IIIC Colorectal Cancer, Stage IIIC Gastric Cancer, Stage IV Gastric Cancer, Stage IVA Colorectal Cancer, Stage IVA Liver Cancer, Stage IVA Pancreatic Cancer, Stage IVB Colorectal Cancer, Stage IVB Liver Cancer, Stage IVB Pancreatic Cancer Intervention / Treatment: OTHER: Computer-Assisted Intervention, DEVICE: Vivofit watch, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DEVICE_FEASIBILITY Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Scheduled to undergo surgery for primary or secondary gastric, colorectal, liver, or pancreas cancer * Able to read and understand English * Patients across all stages of disease * There are no restrictions related to performance status or life expectancy * This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent Exclusion Criteria: * Research participants who have no computer and internet access and/or do not use a computer even if one is present in the household * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Study Objectives Cancer Survivor Registry: The Breast Cancer M.A. P. (Mind Affects the Physical M.A.P.) Project to identify and help us understand the emotional and social needs of breast cancer survivors. Conditions: Cancers Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Having received a cancer diagnosis Exclusion Criteria: * None

Study Objectives * Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs) * Recurrence after treatment with BC-819/PEI and BCG * Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder * After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly Conditions: Transitional Cell Carcinoma of Bladder Intervention / Treatment: DRUG: BC-819/PEI, DRUG: BCG Vaccine Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Patients with superficial papillary transitional cell carcinoma of the bladder for whom BCG is clinically indicated. If CIS is present, diagnosis needs to be confirmed by biopsy prior to the start of the study. 2. Males or females more than 18 years old 3. All papillary tumors must be resected within 8 weeks prior to the start of study therapy. 4. ECOG performance status 2 or less. 5. Adequate hematologic function, as demonstrated by 1. Hemoglobin 10 g/dL or higher 2. ANC 1.5 x 109/L or higher 3. Platelets higher than 100 x 109/L 6. Adequate liver and renal function as demonstrated by 1. AST and ALT each 3.0 x ULN or less 2. Total bilirubin 1.5 x ULN or less 3. Creatinine 1.5 X ULN OR less, creatinine clearance \>60 mL/min 7. If fertile and sexually active, must use adequate contraception 8. Must be able to comply with protocol requirements, including attendance at required clinic visits. 9. Patients must provide written informed consent. - Exclusion Criteria: 1. Patients who are candidates for either partial or total bladder resection, unless either medically contraindicated or who have refused surgery. 2. Patients with a tumor in a diverticulum, in the prostatic urethra, or covering the ureteral orifice. 3. Patients who have received cytotoxic drugs, systemic corticosteroids or any investigational drug for any indication within 4 weeks of the start of protocol treatment. 4. Patients who have received any intravesical therapy other than surgical resection within 8 weeks prior to the start of protocol treatment. 5. Patients who have received radiation therapy for bladder cancer at any time or for any condition within 4 months prior to the start of protocol treatment. 6. Patients who have active infections, including urinary tract infections, whether viral, bacterial or fungal and requiring therapy. 7. Patients who are receiving coumadin. 8. Patients who have had to discontinue a past course of BCG due to toxicity. 9. Patients who are having urinary tract signs or symptoms from recent urinary tract procedures or manipulations, such as biopsies or catheterizations. 10. Patients who are known to be HIV positive. 11. Females who are pregnant or breast feeding. 12. Presence of any medical, psychological or social condition or situation which may, in the investigator's opinion, make it difficult for the patient to tolerate study medication or comply with study procedures and other requirements. This includes but is not limited to active infections, poorly controlled diabetes, uncontrolled cardiac arrhythmias, angina pectoris, or hypertension. -

Study Objectives Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer. Conditions: Ovarian Epithelial Cancer Recurrent, Fallopian Tube Cancer, Primary Peritoneal Cancer Intervention / Treatment: DRUG: PankoMab-GEX, DRUG: Placebo Location: Poland, Hungary, Germany, Romania, Spain, United Kingdom, Russian Federation, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: 1. Female patients ≥18 years of age 2. Histologically-confirmed, TA-MUC1-positive, recurrent epithelial ovarian, or fallopian-tube cancer or primary peritoneal cancer with high-grade (Grade 2 or 3) serous features or a serous component 3. Availability of tumor tissue samples (slices or block) for immune-histological confirmation of TA-MUC1 status (tissue samples could also be stored for other further specified biomarker assessments) 4. Patients were to have received at least 2 lines but not more than 5 lines of chemotherapy prior to start of maintenance treatment; neo-adjuvant lines did not count as previous lines of treatment 5. Patients had to have a documented response to or SD following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within IEC-approved studies) and received the last dose of said chemotherapy ≤6 weeks prior to randomization (response to prior chemotherapy was defined as a PR/CR according to radiological response criteria and/or a confirmed decline in tumor marker CA125 ≥50% from the pre-treatment value for patients who had a pre-treatment value ≥2 x the upper limit of normal \[ULN\]; SD was defined as stable disease according to radiological response criteria with a confirmed lack of increase in tumor marker CA125 from the pre-treatment value for patients who had a pre-treatment value ≥2 × ULN and no clinical progression). Prior to randomization, CA125 had to be below the ULN, or CA125 levels were not to increase \>15% within a time frame \>7 days if above the ULN 6. Progression-free interval of ≤12 months immediately preceding the chemotherapy to which the patient had just responded 7. Sensitive or resistant to the most recent platinum-based chemotherapy preceding the chemotherapy to which the patient had just responded (sensitivity was thereby defined as a recurrence of disease \>6 to ≤12 months after the end of platinum-based chemotherapy, and resistantance was defined as a recurrence of disease ≤6 months after the end of the platinum-based chemotherapy) 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 9. Recovered from all chemotherapy-related toxicities to Grade 1 or Grade 0 according to the NCI-CTCAE Version 4.0, with the exception of alopecia (any grade) and peripheral neuropathy (≤Grade 2) 10. Adequate bone marrow and hepatic function at Screening: * Hemoglobin ≥9 g/dL * White blood cell count ≥3.0 × 109/L * Absolute neutrophil count ≥1.5 × 109/L- Platelet count ≥100 × 109/L * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 × ULN (\<5 × ULN in case of liver metastases) * Bilirubin \<1.5 × ULN (\<3 × ULN in case of liver metastases) * Creatinine \<1.5 × ULN 11. Any patient with childbearing potential (i.e. not surgically sterile or post-menopausal for \>1 year) had to use highly effective contraceptives with a Pearl index \<1% according to the "Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals" (CPMP/ICH/286/95) of the European Medicines Agency (EMA). (Although pregnancy was unlikely to occur in this patient population, any patient with childbearing potential had to be withdrawn from the study in the event of pregnancy) 12. Life expectancy \>3 months 13. Ability and willingness to give written informed consent Exclusion criteria: 1. Refractory to platinum-based chemotherapy (defined as remained progressive or became progressive under any previous platinum-based regimen) 2. Progression-free interval of \>12 months after the most recent antecedent platinum-based chemotherapy regimen 3. Concomitant anti-tumor therapy or immunotherapy 4. Treatment with monoclonal antibodies or investigational agents ≤30 days before randomization (prior anti-MUC1 therapy was not permitted at any time) 5. Limited-field radiotherapy ≤30 days before randomization (extensive prior radiotherapy during or following the last line of chemotherapy was not permitted; radiotherapy prior to the last line of chemotherapy was permitted) 6. Prior allergic reaction to a monoclonal antibody, Grade 3 IRR or any Grade 4 reaction to a monoclonal antibody 7. Known sensitivity to any component of the test product 8. Contraindication to the pre-medication used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, or steroids) 9. Clinical evidence of brain metastasis or leptomeningeal involvement 10. Patients with second primary cancer, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years 11. Primary or secondary immune deficiency 12. Clinically active infections \>Grade 2 using NCI-CTCAE version 4.0 13. Active hepatitis B or C or infection with human immunodeficiency virus (HIV) 14. Myocardial infarction within 6 months prior to Screening 15. Symptomatic congestive heart failure (New York Heart Association Grade 3 or 4), unstable angina pectoris within 6 months prior to Screening, significant cardiac arrhythmia or history of stroke or transient ischemic attack within 1 year prior to Screening 16. Prior or planned major surgery within 30 days prior to randomization and/or incomplete recovery from prior surgery 17. Concomitant use of systemic steroids, except for inhaled, topical or nasal application within 30 days prior to randomization (steroids used for pre-medication were permitted) 18. Active drug or alcohol abuse 19. Any uncontrolled medical condition that could have put the patient at high risk during treatment with an investigational drug, including unstable diabetes mellitus, vena cava syndrome, or chronic symptomatic respiratory disease 20. Pregnancy or lactation 21. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons 22. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous PankoMab-GEX™ administration

Study Objectives This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: Ipatasertib, DRUG: Paclitaxel, DRUG: Placebo Location: Taiwan, Korea, Republic of, Belgium, United States, Singapore, Spain, France, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization * Measurable disease, according to the RECIST v1.1 * Adequate hematologic and organ function within 14 days before the first study treatment * For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment Exclusion Criteria: * Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (\>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent * Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1 * Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer * Previous therapy with Akt, PI3K, and/or mTOR inhibitors * Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study * Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments

Study Objectives The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced) Conditions: Advanced Melanoma, Metastatic Melanoma Intervention / Treatment: BIOLOGICAL: Nivolumab, DRUG: Ipilimumab Location: United States, Netherlands, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Part 1: Inclusion Criteria: * Men and women \>18 years * Eastern Cooperative Oncology Group (ECOG) status = 0 to 1 * Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma * Subject must have histologic or cytologic confirmation of advanced melanoma * Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria * Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies Exclusion Criteria: * Active or progressing brain metastases * Other concomitant malignancies (with some exceptions per protocol) * Active or history of autoimmune disease * Positive test for human immunodeficiency virus (HIV) 1\&2 or known acquired immunodeficiency syndrome (AIDS) * History of any hepatitis * Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40,and anti-CD40 antibodies. However, half the patients must have progressed on anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) monoclonal antibody therapy Part 2, 3 and 4: Inclusion Criteria * Men and women \>16 years * Eastern Cooperative Oncology Group (ECOG) status = 0 to 1 * Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma * Subjects must never received anti-CTLA4 therapy * Subjects must have histologic or cytologic confirmation of advanced melanoma * Subjects must have at least two measurable lesions at baseline by CT or MRI as per RECIST 1.1 criteria * Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies * Subjects in Part 4 must have brain metastases Exclusion Criteria * Active or progressing brain metastases (except for Part 4 subjects) * Other concomitant malignancies (with some exceptions per protocol) * Active or history of autoimmune disease * Positive test for HIV 1\&2 or known AIDS * History of any hepatitis * Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40,and anti-CD40 antibodies

Study Objectives The aims of this three-year study are to: 1. From patients and family perspective to explore the needs for home care after receiving TACE, PEI, and RFA 2. Develop a telephone follow-up and consultation program and examine its effect on self-efficacy, anxiety, depression and quality of life in liver cancer patients receiving non-surgical treatment. Conditions: Hepatocellular Carcinoma Intervention / Treatment: BEHAVIORAL: telephone consultations about psychoeducation program Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with liver cancer in non-surgical treatment * Aged above 18 * Those who are wiling to participate in the research Exclusion Criteria: * None

Study Objectives This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone (dex) in adults with newly diagnosed multiple myeloma (NDMM). The study will consist of a dose-finding phase as well as a parallel dose-expansion phase to determine the optimal regimen. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* The study was placed on full clinical hold by the United States (US) Food and Drug Administration (FDA) on 05 Sep 2017. The decision by the FDA was based on data from non-Celgene-sponsored studies related to risks of anti-programmed cell death 1 (PD-1), pembrolizumab, in combination with immunomodulatory agents. As the result, the study was closed for further enrollment, and all subjects were discontinued from all study treatments (durvalumab, lenalidomide and dexamethasone). All subjects are being followed for second primary malignancies (SPMs), every 6 months for 5 years after the last subject has been enrolled as per protocol. After stopping data collection in the clinical database, any SPM events will continue to be recorded in the subject's source documents, and reported to Celgene Drug Safety. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Durvalumab, DRUG: Lenalidomide, DRUG: Dexamethasone Location: Netherlands, Germany, United States, Canada, Spain, Denmark, Italy, Finland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects must satisfy the following criteria to be enrolled into the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF) 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements 4. Subject must have documented diagnosis with previously untreated (for cohort C, the induction and consolidation treatment along with the first autologous stem cell transplantation (ASCT) are allowed), symptomatic multiple myeloma (MM) as defined by the criteria below: MM diagnostic criteria (all 3 required); - Monoclonal protein present in the serum and/or urine * Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma * Any one or more of the following myeloma defining events: 1. one or more of the following Myeloma-related organ dysfunction (at least one of the following); * (C) Calcium elevation (serum calcium \>11.5 mg/dl )(\>2.65 mmol/L) * (R) Renal insufficiency (serum creatinine \>2 mg/dl)(177 µmol/L or more) or creatinine clearance \< 40 ml/min * (A) Anemia (hemoglobin \<10 g/dL or \>2 g/dL below the lower limit of laboratory normal) * (B) Bone lesions (lytic or osteopenic) one or more bone lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-computed tomography (PET-CT) 2. one or more of the following biomarkers of malignancy: * Clonal bone marrow plasma cell percentage ≥60% * Abnormal serum free light-chain ratio ≥100 (involved kappa) or \< 0.01 (involved lambda) * \>1 focal lesions detected by functional imaging including PET/CT and/or whole body magnetic resonance imaging (MRI) AND have measurable disease by protein electrophoresis analyses as defined by the following: * Immunoglobulin G (IgG) MM: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine Mprotein level ≥ 200 mg/24 hours * Immunoglobulin A (IgA) MM: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours * Immunoglobulin M (IgM) MM (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours * Immunoglobulin D (IgD) MM: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours * Light chain MM: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 6. Females of childbearing potential (FCBP) must: a. Have two negative pregnancy tests as verified by the investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. b. She must either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and be source documented) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study treatment, during the study therapy (including dose interruptions), and for 90 days after discontinuation of study treatment. c. Refrain from egg cell and blood donation for 90 days after the final dose of durvalumab. 7. Male subjects must : a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and for at least 90 days following study treatment discontinuation, even if he has undergone a successful vasectomy. b. Refrain from sperm and blood donation for at least 90 days after the final dose of durvalumab. 8. For Cohort A subject must be transplant non-eligible (TNE) and meet at least one of the following high risk factors: a. Cytogenetic abnormalities finding in malignant myeloma clone with t(4; 14); and / or del(17p); and / or 1q amplification; and / or t(14:16); or b. International Staging System (ISS) Stage III; or c. Serum lactate dehydrogenase (LDH) \> 2\*ULN (upper limit of normal). 9. For Cohort B subject must be ≥ 65 years of age at the time of signing the informed consent form (ICF) and transplant non-eligible (TNE); excluding the subjects who meet the Cohort A criteria. 10. For Cohort C subject must be after first autologous stem cell transplantation (ASCT) for NDMM and meet the following criteria: 1. Have a post-transplant response as Partial response (PR) or better at the time of enrollment to this study; 2. Have one of the following high risk factors at the time of NDMM diagnosis; * Cytogenetic abnormalities finding in malignant myeloma clone with t(4; 14); and / or del(17p); and / or 1q amplification; and / or t(14; 16); or * ISS stage III; or * Serum LDH \> 2\*ULN; c. Minimal residual disease (MRD) positive (defined as more than 1 malignant cell in 105 cells) measured by ClonoSIGHT™NGS assay of a BMA sample) at the time of enrollment to this study; BMA sample collected at the time of multiple myeloma diagnosis, prior to induction therapy available for central MRD assessment by ClonoSIGHT™NGS assay Exclusion Criteria: * The presence of any of the following will exclude a subject from enrollment: 1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid (ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of Cycle 1 Day 1), for Cohort C, the induction and consolidation treatment along with the first Autologous stem cell transplantation (ASCT) are allowed) 2. Any of the following laboratory abnormalities: 1. Absolute neutrophil count (ANC) \< 1,000/μL 2. Untransfused platelet count \< 75,000 cells/μL 3. Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) \> 2.5\*upper limit of normal (ULN) 4. Serum total bilirubin \> 1.5\*ULN or \> 3.0 mg/dL for subjects with documented Gilbert's syndrome 5. Corrected serum calcium \>13.5 mg/dL (\> 3.4 mmol/L) 3. Renal failure requiring hemodialysis or peritoneal dialysis 4. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, subject with unstable cardiac disease as defined by: cardiac events such as myocardial infarction (MI) within the past 6 months, NYHA (New York Heart Association) heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment 5. Peripheral neuropathy ≥ Grade 2 6. Primary AL (immunoglobulin light-chain) amyloidosis and myeloma complicated by amyloidosis 7. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin 3. Carcinoma in situ of the cervix 4. Carcinoma in situ of the breast 5. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) or prostate cancer that is curative 8. Subjects is positive for human immunodeficiency virus (HIV); chronic or active hepatitis B or active hepatitis A, or C 9. Subject had prior exposure to immunotherapy, including, but not limited to, other anti- CTLA-4,anti-PD-1, anti-PD-L1 monoclonal antibody or inhibitor, cell-based therapies, or cancer vaccines 10. Subjects has history of organ or allogeneic stem cell transplantation 11. Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma, or plasma cell leukemia 12. Known or suspected hypersensitivity to the excipients contained in the formulation of durvalumab, lenalidomide, or dexamethasone 13. Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment 14. Received prior treatment (for any reason)with a monoclonal antibody within 5 half-lives of initiating study treatment 15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment 16. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection); 2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent; 3. Steroids as premedication for hypersensitivity reactions (eg, computed tomography (CT) scan premedication); 17. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (eg, colitis, Crohn's disease\], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \[granulomatosis with polyangiitis); myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: 1. Subjects with vitiligo or alopecia; 2. Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or 3. Subjects with psoriasis not requiring systemic treatment; 18. History of primary immunodeficiency 19. Subject has incidence of gastrointestinal disease that may significantly alter the absorption of LEN 20. Receipt of live, attenuated vaccine within 30 days prior to the first dose of durvalumab 21. Unable or unwilling to undergo protocol required thromboembolism prophylaxis(for Cohort C, this will be only for the subjects who have a history of VTE) 22. Females who are pregnant, nursing or breastfeeding, or intend to become pregnant during the participation to the study 23. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 24. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 25. Any condition that confounds the ability to interpret data from the study

Study Objectives This study will test how effective the drug, Carfilzomib, reduces progression of prostate cancer in patients who have previously received chemotherapy and androgen inhibitors. Carfilzomib is approved for multiple myeloma but is not approved for prostate cancer. Therefore, it is considered investigational. Other approved methods of treatment for metastatic prostate cancer have demonstrated only modest benefits. Novel and tolerable agents are necessary to make further gains and extend overall survival. Conditions: Metastatic Castration-resistant Prostate Cancer Intervention / Treatment: DRUG: Carfilzomib, DRUG: Dexamethasone, DRUG: Acyclovir Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically proven adenocarcinoma of the prostate * Metastatic disease * Progressive disease (PSA, radiologic, symptomatic) following abiraterone acetate and/or Enzalutamide (prior sipuleucel-T and chemotherapy are allowed); PSA progression is defined as baseline increase followed by any PSA increase ≥1 week apart. * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Patients, even if surgically sterilized (i.e., status post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse if female partner of childbearing age. * An elevated PSA level of \>2ng/mL for patients progressing by PSA criteria is required (last confirmatory sample must be \>2ng/mL) * Currently on androgen ablation hormone therapy (a luteinizing hormone- releasing hormone (LHRH) agonist/antagonist or orchiectomy) with testosterone level \<50ng/dL) * Has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2 * Left ventricular ejection fraction (LVEF) ≥40% on 2-D transthoracic echocardiogram (ECHO); Multi-gated Acquisition Scan (MUGA) is acceptable if ECHO is not available. * ≥19 years of age * Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE Version 4.03 Grade \<1, in the opinion of the treating physician. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patient has a platelet count of \<100,000/mm3, or absolute neutrophil count of \<1500/mm3 or Hemoglobin \<8.0gm/dL * Patient has a calculated or measured creatinine clearance of \<30 milliliters (mL)/minute * Patient has total bilirubin \>2 x upper limit of normal (ULN), or aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>3.5 x ULN * Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment * Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Before study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. * Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial. * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of: a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the breast; c) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas. * Known HIV, hepatitis B and hepatitis C infection * Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization * Prior treatment with bortezomib * Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize Carfilzomib) * Has received prior radiation to \>50% of the bone marrow * Has had significant bleeding/thrombosis in previous 4 weeks * Has received treatment with radiation therapy, surgery, chemotherapy, or an investigational agent within 4 weeks prior to registration, (6 weeks for radiation therapy, radionuclides, nitrosoureas, or Mitomycin C) or who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Has evidence of uncontrolled Central Nervous System (CNS) involvement (previous radiation and off steroids is acceptable) * Patients may not be receiving any other investigational agents * Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection * Is unable to comply with study requirements * 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.

Study Objectives The primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Conditions: Lung, Prostate, Breast, Colon, Pancreatic, Renal, Bladder,Thyroid, Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut) Cancer, Cancer of the Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut), Sarcoma Cancer, Cancer of Neuro-onc, Parathyroid, Desmoid Tumors, Melanoma Cancer Intervention / Treatment: OTHER: data collection Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Adult patients \>= 18 years of age * Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence. * Good operative candidate as determined by the treating physician and/or multidisciplinary team * Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: * Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery * Vulnerable patient populations

Study Objectives Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is locoregional. In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the surgical resection. The effect of radiotherapy combined with surgery is uncertain and until now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to high risk of organ toxicity nearby. The helical tomotherapy is an innovative equipment radiotherapy to make conformational radiotherapy modulation intensity and is particularly suitable for irradiations precision (imaging mode associated with daily scanner) in large complex volumes. Increasing doses (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical tomotherapy should allow to improve the efficacy of radiotherapy. Conditions: Liposarcoma Intervention / Treatment: RADIATION: Radiotherapy Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Liposarcoma histologically proven, in case of non-contributive biopsy: diagnosis radiologically validated within a multidisciplinary meeting 2. Protocol TOMOREP technically feasible, 3. Patients over 18 years 4. Considered as resectable even if multi-visceral excision is needed 5. Absence of morbidity contra-indicating surgery. The evaluation will be performed by the surgeon or the radiotherapist according to the definitions by the ASA classification. 6. Original form (as well as tumors made after first incomplete excision) and form in first relapse. 7. Life expectancy greater than 6 months 8. Patient signed informed consent, 9. Patient affiliated to a social security. Exclusion Criteria: 1. Metastasis associated 2. Extension intraperitoneal associated, mesenteric extension 3. bilaterally 4. Against disease-indicating the need for surgery (ASA 3 and 4). 5. Contra-indication to radiotherapy (such as prior radiotherapy into the volume to treat). 6. Patient included in another clinical trial 7. Patient unable to undergo medical monitoring test for any geographical, social or psychological reasons, 8. Private patient freedom and major subject of a measure of legal protection or unable to consent.

Study Objectives The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes. Conditions: Sigmoid Diverticulosis, Sigmoid Diverticulitis, Colorectal Malignancy Intervention / Treatment: PROCEDURE: Left-sided colonic resection Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient, male or female, from 18 years old * Patient with sigmoid diverticulosis or diverticulitis * Patient with colon malignancy * Patient with rectum malignancy * Patient with no contraindication to anesthesia and to colonic resection surgery * Patient able to understand the study and to provide informed consent * Patient affiliated to the French social security system Exclusion Criteria: * Patient undergoing emergency surgery * Patient undergoing abdomino-perineal resection * Patient undergoing colonic resection without anastomosis (Hartmann's colostomy) * Patient with proven or unclear allergic reactions * Pregnancy or breast-feeding * Patient in exclusion period (determined by a previous study or in progress) * Patient in custody * Patient under guardianship

Study Objectives Phase I trial to study the effectiveness of combining flavopiridol, fluorouracil, and leucovorin with or without irinotecan in treating patients who have advanced cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: alvocidib, DRUG: leucovorin calcium, DRUG: fluorouracil, DRUG: irinotecan hydrochloride Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed malignancy * Unresectable tumor * No known standard therapy with curative potential or capability of extending life expectancy * No untreated CNS metastases * Performance status - ECOG 0-2 * At least 12 weeks * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL * Direct bilirubin no greater than upper limit of normal (ULN) * AST no greater than 3 times ULN (5 times ULN if liver metastases present) * Creatinine no greater than 1.5 times ULN * No New York Heart Association class III or IV heart disease * No seizure disorder * No uncontrolled infection * No baseline diarrhea, defined as at least 4 loose or liquid stools/day * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * More than 4 weeks since prior biologic therapy * More than 4 weeks since prior immunotherapy * No concurrent immunotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and fully recovered from acute reversible effects * No other concurrent chemotherapy * More than 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow * No concurrent radiotherapy * No other concurrent ancillary investigational therapy

Study Objectives This is a parallel human intervention trial to determine to what extent a dietary intervention of broccoli or peas can change the expression (switching on or off) of genes in prostate tissue in men diagnosed with high-grade Prostate Intraepithelial Neoplasia (PIN). Conditions: Prostatic Intraepithelial Neoplasia Intervention / Treatment: DIETARY_SUPPLEMENT: Broccoli, DIETARY_SUPPLEMENT: Peas Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: BASIC_SCIENCE Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Men with a previous diagnosis of high-grade Prostatic Intraepithelial Neoplasia * BMI \>18.5 or \<35 * Aged between 30-70 years Exclusion Criteria: * Undergoing chemopreventive therapy * Receiving testosterone replacement medicines * Active infection requiring treatment * BMI \<18.5 or \>35 * Diagnosed with diabetes * Unable to give informed consent

Study Objectives This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive disease. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: IMGN779 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Dose Escalation: Patients with relapsed or refractory AML * Dose Expansion: Patients with relapsed AML or patients who refuse, or are not suitable candidates for induction therapy Exclusion Criteria: * Dose Escalation: Acute Promyelocytic Leukemia * Any concurrent anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational agents (with the exception of hydroxyurea or leukapheresis for control of hyperleukocytosis) within 14 days or five half-lives of drugs, whichever is shorter, prior to Cycle 1 Day 1 * AML patients with known, active leptomeningeal/central nervous system (CNS) involvement * Prior treatment with IMGN779 * Women who are pregnant or breast feeding

Study Objectives In this project, we intend to conduct a randomized pilot trial of a structured behavioral intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory, to promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening recommendations. We will also collect qualitative feedback on perceptions of the intervention to inform its refinement. Conditions: Colorectal Cancer Intervention / Treatment: BEHAVIORAL: Text Messaging Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Present at Strong Memorial Hospital or Noyes Community Hospital Emergency Departments * Age 45-75 * English or Spanish speaking * Capacity to consent Exclusion Criteria: * Personal and/or family history of colorectal cancer * Personal history of inflammatory bowel disease * History of abdominal or pelvic radiation to treat a prior cancer * Non-English and Non-Spanish speaking * Inability to consent * Lack of text-capable mobile phone and/or inability to use text function

Study Objectives To evaluate the safety, immune-response and efficacy of GSK Biologicals' EBV vaccine in a population at risk of developing infectious mononucleosis. Each subject will receive three doses of vaccine or placebo during the study period. Conditions: Epstein Barr Virus (EBV) Infection Intervention / Treatment: BIOLOGICAL: EBV vaccine (268664) Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening. * Written informed consent obtained from the subject prior to enrolment. * Seronegative for EBV antibody. Exclusion Criteria: * Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period. * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * Family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * History of intravenous drug abuse within the past 2 years. * Known or suspected allergy to any vaccine component.

Study Objectives The primary objective of this study is to evaluate the role of elastography (along with echographic and cytological data) as a diagnostic tool for thyroid cancer Conditions: Thyroid Nodule, Thyroid Neoplasms Intervention / Treatment: OTHER: Elastography Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for six months of follow-up * The patient is programmed for surgical excision of all nodules determined to be not benign according to cytological criteria Exclusion Criteria: * The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant * The patient is breastfeeding * The patient has a contraindication for a treatment used in this study * The patient has a contraindication for surgical excision of his/her thyroid nodule * The patient refused to be operated

Study Objectives RATIONALE: Printed educational materials and counseling by telephone may improve colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer. PURPOSE: This randomized phase III trial is studying standard or personalized printed educational materials with or without telephone counseling to compare how well they work in increasing colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer. Conditions: Colorectal Cancer Intervention / Treatment: OTHER: counseling intervention, OTHER: educational intervention, OTHER: study of socioeconomic and demographic variables Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: Allocation: RANDOMIZED Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Sibling of a patient diagnosed with adenocarcinoma of the colon or rectum * Patient (proband) must meet the following criteria: * Diagnosed in 1999 or later * Currently living * Seen in Community Clinical Oncology Program member hospital * 60 and under at diagnosis * No history of hereditary cancer syndrome (e.g., familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer) (patient and sibling) * No history of colorectal cancer or colorectal polyps (sibling) * No history of inflammatory bowel disease (patient and sibling) PATIENT CHARACTERISTICS: * Age 40 and over OR within 10 years of proband's (patient's) age at diagnosis * English speaking PRIOR CONCURRENT THERAPY: * No prior colorectal cancer screening * May have undergone prior screening provided they have not followed, or do not plan to follow, physician's recommendation for screening

Study Objectives This is a two-part study that will determine, if: 1) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to exemestane; and 2) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to both ridaforolimus and dalotuzumab as single agents, in participants with breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: ridaforolimus + dalotuzumab, DRUG: exemestane, DRUG: ridaforolimus, DRUG: dalotuzumab Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant: * Has a confirmed diagnosis of breast cancer that is metastatic or locally advanced and is estrogen receptor positive and human epidermal growth factor receptor 2 (HER-2) negative ; * Is post-menopausal; * Is at least 18 years of age; * Has a life expectancy of at least 3 months; * Has had a recurrence or progression of cancer after prior treatment and patient has received at least one line of endocrine therapy for metastatic disease, OR the patient's cancer has recurred within 6 months after the last dose of anastrozole or letrozole; * Has an available archival tumor specimen; * Has voluntarily agreed to participate by signing informed consent. Exclusion Criteria If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant: * Is receiving any other systemic tumor therapy; * Has previously received rapamycin or rapamycin analogs; * Has received prior treatment with insulin-like growth factor 1 receptor (IGF-1R) inhibitors, phosphoinositide 3-kinase (PI3K) inhibitors, or other experimental agents that target the PI3K, protein kinase B (AKT), or mammalian target of rapamycin (mTOR) pathways; * Has known allergy to macrolide antibiotics; * Has an active infection that requires antibiotics; * Has significant or uncontrolled cardiovascular disease; * Has poorly controlled Type 1 or 2 diabetes mellitus; * Is known to be human immunodeficiency virus (HIV) positive; * Has a known history of active Hepatitis B or C.

Study Objectives The purpose of this study is to determine if hypnotic relaxation therapy is a more effective intervention for improving self-image in women who have been diagnosed with breast or gynecologic cancer when compared to progressive muscle relaxation therapy. Conditions: Breast Cancer, Ovarian Cancer, Uterine Cancer, Cervical Cancer Intervention / Treatment: BEHAVIORAL: Hypnotic Relaxation Therapy, BEHAVIORAL: Progressive Muscle Relaxation Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * a history of any stage of breast or gynecologic cancer * reported a change in body/self-image since diagnosis and wish to improve it. Two screening questions will be used: Has body image or self-image changed in an unwanted way since the cancer diagnosis? (Answer must be yes.) Would the potential participant like to be able to do something to improve body image or self-image? (Answer must be yes.) * Concurrent cancer treatment of any kind is allowed, but the participant can also have completed all treatment * Performance status of 2 or better Exclusion Criteria: * Diagnosis of a major depressive episode, an acute anxiety disorder, psychosis, or schizophrenia as listed in the patient's medical history per Diagnostic and Statistical Manual for Mental Health-IV criteria in the chart and/or by self-report * Past history of sexual abuse. * Currently on 2 or more antidepressant therapies for mood disturbance of any kind. Past use is allowed, just not current use. * Currently on 2 or more anti-anxiety therapies. Past use is allowed, just not current use.

Study Objectives This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea. Conditions: Genital Warts, Perianal Warts Intervention / Treatment: DRUG: Polyphenon E (Veregen) 15% ointment, OTHER: Green Tea Beverage with defined catechin content Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: For both subject groups (treatment arms 1 + 2): 1. Male and female subjects, 18 years of age or older at the time of enrollment. Subjects will be stratified by gender. 2. Written informed consent. 3. Ability to comply with the requirements of the study. For patients (treatment arm 1, additionally): 4. Clinical diagnosis of external genital and perianal warts which can be located: in men: over the glans penis, foreskin, penis shaft, and scrotum; in women: on the vulva; in both gender: in the inguinal, perineal, and perianal areas. 5. A total wart area of at least 100 mm² and a maximum of 2500 mm². 6. For women of child-bearing potential: negative pregnancy test and willingness to use two effective methods of contraception throughout their study participation is mandatory (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant, or sterilization (for contraception) plus condom (for prevention of reinfection). For male patients and partners of male patients who are of childbearing potential: use of two methods of effective contraception during the treatment period is mandatory (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant, or sterilization (for contraception) plus condom (for prevention of reinfection). Exclusion Criteria: For both subject groups (treatment arms 1 + 2): 1. Participation in an investigational trial within 30 days prior to enrollment and for the whole study duration. 2. Any current uncontrolled infection. 3. Current known acute or chronic infection with Hepatitis virus B or C. 4. Known Human immunodeficiency virus infection. 5. Subjects with known history of chronic (diabetes, hypertension, gastritis, etc.) or consuming diseases (cancer, multiple sclerosis, etc.), chronic inflammation, or liver or renal insufficiency. 6. Any chronic or acute condition including the skin, susceptible, in the opinion of the investigator, of interfering with the evaluation of the drug effect. 7. Laboratory data above the upper normal range. 8. Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration, with the exception of acyclovir and the related drugs famciclovir and valaciclovir. 9. Systemic intake of immunosuppressive or immuno-modulatory medication or vaccination within 30 days prior to enrollment and for the whole study duration. 10. Organ allograft recipient. 11. Medication intake, including over the counter products and dietary supplements such as iodine, fluoride, or vitamins, which would interfere with study results, except paracetamol and oral contraceptives, within one week before and during the study course. Subjects are not allowed to consume green, black or Oolong tea as well as red wine or any other beverages or foods containing green tea extract within three days before each blood sampling visit. 12. For female patients: pregnancy or lactation. 13. Blood transfusion within 30 days prior to enrollment. 14. Subjects who are placed in an institution due to a judicial or official directive. For patients (treatment arm 1, additionally): 15. Previous participation in a trial investigating sinecatechins in the treatment of external genital and perianal warts. 16. Treatment of external genital warts within 30 days prior to enrollment and for the whole study duration. 17. Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 months prior to enrollment. 18. Any current and/or recurrent pathologically relevant genital infections other than genital warts. 19. Known allergies against any of the ingredients of the ointment.

Study Objectives The purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere, once per week, with radiation is a new treatment for cervical cancer. This study will also see how well this treatment regimen can be tolerated. Conditions: Cervix Neoplasm Intervention / Treatment: DRUG: docetaxel, PROCEDURE: Radiation Therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including FIGO (International Federation of Gynecologists and Obstetricians) stage IB to IVA with or without pelvic adenopathy. * No evidence of para-aortic or distant metastases. Must have evaluable disease. * Zubrod Performance Status 0-2 or Karnofsky Performance Status \> 60 * Laboratory values must be as follows: White blood cell count: \> 3,000/mm3,Absolute granulocyte count: \> 1,500/mm3, Hemoglobin \> 8.0 g/dl, Platelets: \> 100,000/mm3, Serum creatinine: \< 2.5 mg/dl, Serum calcium: \< 1.3 x institutional upper normal limit,Hepatic criteria as follows: Total Bilirubin \< ULN for the institution, * Signed study-specific informed consent p * Age \> 18 years. * Peripheral neuropathy must be \< grade 1. Exclusion Criteria: * Prior or simultaneous malignancies (other than skin cancer) unless disease-free * Medical illness preventing the use of taxane-based chemotherapy. * Carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic. * Previous or current medical or psychiatric illness that would prevent informed consent * Patients known to be infected with HIV or a history of AIDS are excluded. * Prior surgery for carcinoma of the cervix other than a biopsy. * Patients with para-aortic disease. * Previous pelvic radiation therapy or systemic chemotherapy is not permitted. * Women who are pregnant or breast-feeding are excluded from this study. * Previous history of hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 must be excluded.

Study Objectives Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Plitidepsin in Combination with Sorafenib or Gemcitabine in Patients with Advanced Solid Tumors or Lymphomas to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of plitidepsin in combination with sorafenib or gemcitabine in patients with advanced solid tumors or lymphomas. Conditions: Advanced Solid Tumors, Lymphomas Intervention / Treatment: DRUG: Plitidepsin and Sorafenib, DRUG: Gemcitabine and Plitidepsin Location: United States, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age ≥ 18 years * ECOG performance status (PS) of ≤ 1 * Life expectancy ≥ 3 months * Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors or lymphomas (excluding B-cell derived lineage and/or primary cutaneous and/or leukemic disease) refractory to standard therapy and with reasonable chance to benefit from any of these combinations according to the investigator's opinion. * Patients entered at the expansion cohort of the RD must have: a) measurable disease according to RECIST, or to International Working Group Criteria (IWC) for lymphoma patients or b) Evaluable disease by serum markers in the case of prostate and ovarian cancer (according to Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and Gynecologic Cancer Intergroup (GCIG) specific criteria, respectively * At least 4 weeks since last chemotherapy (6 weeks since nitrosoureas and mitomycin C), immunotherapy or any other pharmacological treatment and radiotherapy. In the case of hormone-sensitive cancer progressing while on hormone therapy (i.e., breast, prostate cancer), hormone therapy must be either stopped 4 weeks before or continued during the trial * Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ 7 days before inclusion in the study): a) Platelet count ≥100 x109/L (≥ 75 x 109/L for lymphoma patients), hemoglobin ≥9.0 g/dL (≥ 8.0 g/dL for lymphoma patients) and absolute neutrophil count (ANC) ≥1.5 x109/L (≥1.0 x109/L for lymphoma patients). b) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤ 3.0 x the upper limit of normal (ULN), independently of the presence of liver metastases. c) AP ≤2.5 x ULN (≤5 x ULN in case of extensive bone metastases). d) Total bilirubin ≤1.5 x ULN (unless due to indirect hyperbilirubinemia for the gemcitabine combination arm only). e) Calculated CrCl: ≥ 40 mL/minute (by means of Crockroft and Gault´s formula). f) CPK ≤ 2.5 x ULN. g) Albumin ≥2.5 g/dL. h) Troponin I ≤ULN * Recovery to grade ≤1 from any AE derived from previous treatment (excluding alopecia of any grade and peripheral neuropathy ≤ grade 2) * LVEF by ECHO or MUGA above the lower normal limit. * Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include complete abstinence, intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier * Voluntarily signed and dated written informed consent prior to any specific study procedure. Exclusion Criteria: * Previous treatment with any of the study drugs (in the expansion cohort at the RD). * Concomitant diseases/conditions: * History or presence of unstable angina, myocardial infarction, valvular heart disease or congestive heart failure. * Previous mediastinal radiotherapy. * Previous treatment with doxorubicin at cumulative doses in excess of 450 mg/m2 * Symptomatic arrhythmia or any arrhythmia requiring ongoing treatment, and/or prolonged QT-QTc \> to grade 1. * Active uncontrolled infection. * Myopathy or any clinical situation that causes significant and persistent elevation of CPK (\>2.5 x ULN in two different determinations performed with one week apart). * Limitation of the patient's ability to comply with the treatment or follow-up protocol. * Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study. * Peripheral neuropathy \>grade 2 * Symptomatic, progressive or requiring-corticosteroids documented brain metastases or leptomeningeal disease. Controlled and stable brain metastases without steroids are allowed * Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding * Patients who have had radiation therapy in greater than 35% of the bone marrow * History of previous bone marrow and/or stem cell transplantation. (Not for patients treated at RD in the expansion cohort) * High transfusional requirements (\> 2 packages of red blood cells and/or 1 platelets transfusion) in the 30 days prior to inclusion in the study * Participation in another clinical trial or concomitant treatment with any investigational product in the 30-day period prior to inclusion in the study. * For sorafenib treatment only: a) Hypersensitivity to sorafenib or any component of the formulation. b) Need of chronic exposure to antacids, H-2 antagonists or proton-pump inhibitors. c) Current need for anticoagulation treatment (including low dose warfarin and LMWH treatment at full anticoagulant doses). * Abnormal thyroid function \[as per normal serum thyroid stimulating hormone (TSH) within 14 days of first dose of study treatment). * Uncontrolled arterial hypertension (≥160/100) despite optimal medical therapy. * Child-Pugh grade C hepatic cirrhosis of any cause * For gemcitabine treatment only: * Hypersensitivity to gemcitabine or any component of the formulation. * Impending need for palliative radiotherapy to ameliorate painful metastases.

Study Objectives The aim of this study is to identify new prognostic factors in patients affected by advanced pancreatic carcinoma treated with first line chemotherapy with FOLFIRINOX regimen. Primary objective is the identification of clinical, laboratory and pathologic factors affecting overall survival of these patients. Conditions: Pancreatic Cancer Non-resectable Intervention / Treatment: DRUG: FOLFIRINOX Location: Italy Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * age \>18 years * citologically or histologically confirmed pancreatic carcinoma * disease stage III or IV according to the American Joint Committee on Cancer (AJCC) staging system * access to clinical informations collected before first-line starting * availability of objective response evaluation and survival data * written informed consent Exclusion Criteria: * diagnosis of other neoplasia than pancreatic carcinoma * treatment with drugs other than FOLFIRINOX * treatment with experimental drugs in combination with FOLFIRINOX * unavailability of clinical and pathological data

Study Objectives The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation. Conditions: Carcinoma, Hepatocellular, Hepatitis, Viral, Human Intervention / Treatment: DRUG: 131 I-lipiodol Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Men or women , aged between 18 and 75 years old * Cirrhosis or chronic hepatitis associated with C, B, delta infection or alcool intake or both and confirmed by liver biopsy * One or two HCC nodules treated by surgical or percutaneous ablation (ethanol, acetic acid 50% or radiofrequency). * The efficacy of the initial curative treatment will be assessed by the following criteria: alpha-fetoprotein concentration \< or equal 25ng/ml, no progression in size of the tumour demonstrated by ultrasonography and no arterial hypervascularization on CT scan imaging Exclusion Criteria: * HIV coinfection associated with a CD count\<200/mm3 and a viral charge\>5000 HIV RNA copies/ml * Documented iodine intolerance * Respiratory insufficiency * Decompensated cirrhosis (Child-Pugh score over 8) * Bilirubin concentration over 51 µmol/l * Portal or hepatic vein thrombosis * Extra-hepatic metastasis * Excessive alcohol intake (over 50g per day) * Blood platelet count below 50000/mm3 * Neutrophil count above 1500/mm3 * Creatininemia over 120µmol/l * Myocardial infarction or rhythm disorders * Psychiatric disease with hospitalization * Previous treatment for hepatocellular carcinoma * Pregnant or breastfeeding * Treatment with interferon and/or ribavirin 3 months before inclusion * Treatment with tamoxifen or somatostatin analogs or systemic chemotherapy

Study Objectives This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread. Conditions: Cirrhosis, Early Hepatocellular Carcinoma, Fibrosis, Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma Intervention / Treatment: OTHER: Ultrasound Tomography Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: For Healthy Volunteers 1. Patients over 18 years of age. 2. Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures. For HCC patients 1. Patients over 18 years of age. 2. Patient with confirmed diagnosis of HCC, and untreated or Patients with Suspected HCC (Suspected HCC nodules should preferably be smaller than 3 cm and preferably within 6 cm in depth of the transducer head to minimize attenuation) and untreated or Patients at a higher risk of HCC undergoing a screening program by Ultrasound. Exclusion Criteria: For Healthy volunteers 1. Patients who are not likely to comply with the protocol requirements. For HCC patients 1. Patients should not be taking other Investigational Agents. 2. Concomitant medications for treatment of the target lesion.

Study Objectives The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients. Conditions: Lung Neuroendocrine Neoplasm Intervention / Treatment: DRUG: RAD001 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed carcinoid tumors * Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible Exclusion Criteria: * Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible) * Received Cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment * Patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer * Prior therapy with RAD001 or other mTOR inhibitors (sirolimus, temsirolimus, everolimus) Other protocol-defined inclusion/exclusion criteria may apply.

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia. Conditions: Leukemia Intervention / Treatment: BIOLOGICAL: Filgrastim (G-CSF), DRUG: Cyclophosphamide, DRUG: Fludarabine Phosphate, PROCEDURE: Peripheral Blood Stem Cell Transplantation Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: Advanced chronic lymphocytic leukemia (Rai stage 3 or 4) with at least one of the following high-risk factors: Beta-2 microglobulin 3 or greater Abnormalities of chromosome 17 Other cytogenetic abnormalities Refractory to fludarabine-based chemotherapy or failure to achieve complete remission after 6 courses of a fludarabine-based regimen HLA-identical sibling donor willing and able to undergo apheresis for harvest of G-CSF-stimulated peripheral blood stem cells PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Zubrod 0 or 1 Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No symptomatic cardiac disease Pulmonary: No symptomatic pulmonary disease Other: No active uncontrolled infection PRIOR CONCURRENT THERAPY: See Disease Characteristics

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase II trial is studying three regimens of combination chemotherapy to compare how well they work in treating women with stage I or stage II breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: cyclophosphamide, DRUG: doxorubicin hydrochloride, DRUG: epirubicin hydrochloride, DRUG: mitoxantrone hydrochloride, DRUG: vinorelbine tartrate, PROCEDURE: conventional surgery, RADIATION: radiation therapy Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: Masking: NONE

DISEASE CHARACTERISTICS: * Histologically confirmed primary breast cancer that is potentially operable * Synchronous bilateral tumors eligible * At least 3 cm in maximum diameter * Tumors at least 2 cm eligible provided primary chemotherapy is deemed appropriate and radical surgery would otherwise be required * No evidence of metastatic disease * No prior breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 to 70 Sex: * Female Menopausal status: * Not specified Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 150,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Transaminases no greater than 1.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No uncontrolled angina pectoris * No heart failure * No clinically significant uncontrolled cardiac arrhythmias * LVEF at least 50% Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No medical or psychiatric condition that impairs ability to cope physically or psychologically with the chemotherapy regimen * No other serious uncontrolled medical condition * No other prior malignancy except basal cell carcinoma of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Study Objectives Individuals with resolved hepatitis B, characterized as hepatitis B surface antigen (HBsAg)-negative and hepatitis B core antibody-positive, have latent hepatitis B virus (HBV) infection in their liver tissue. Cytotoxic chemotherapy and hematopoietic stem cell transplantation sometimes trigger the reactivation of latently infected HBV, resulting in de novo hepatitis B. Although de novo hepatitis B could cause acute liver failure or chronic hepatitis, an effective management strategy for de novo hepatitis B has not been well established. Risk factors and effective management for de novo hepatitis B will be clarified. Conditions: Hepatitis B Intervention / Treatment: Location: Japan Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * HBsAg-negative but anti-HBc-positive Exclusion Criteria: * Serum HBV DNA-negative

Study Objectives Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites. Conditions: Lung Cancer Metastatic Intervention / Treatment: PROCEDURE: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes, PROCEDURE: Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes Location: Italy Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Age \>18 years at the time of the procedure; * Suspected advanced, treatment naïve non-squamous NSCLC ; * Indication to biopsy for diagnosis and/or molecular profiling; * Written informed consent to the study participation. Exclusion Criteria: * Patients with known non-squamous NSCLC sent for re-biopsy after first or second line treatment; * Inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day); * Platelet count \<50.000 per μL; * Inability or unwillingness to provide a written informed consent.

Study Objectives Living with breast cancer and forms of treatment, among them radiation therapy can cause both side effects such as pain, fatigue and skin changes that affect the well-being, as anxiety, feelings of isolation and changes in routine, which generate existential conflicts and allow the origin of the spiritual anguish phenomenon, which in turn, aggravates the physical and emotional symptoms and the ability to fight the disease. Thus, this study aims to evaluate the effect of intercessory prayer on levels of spiritual distress, religious / spiritual coping, psychological morbidity (anxiety and depression) and amylase levels salivary present in patients with breast cancer radiotherapy. Conditions: Breast Cancer Intervention / Treatment: OTHER: intercessory prayer, RADIATION: Radiotherapy Location: Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Individuals diagnosed with breast cancer in adjuvant and neoadjuvant radiotherapy treatment; * Both female and male participants are being studiedolder; * Minimum age of participants is 18 years. Exclusion Criteria: * Not being with consciousness, memory and orientation preserved; * Patients with clinical conditions that affect the continuity in the study or express request not to continue participating in the study.

Study Objectives Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms. Conditions: Breast Cancer, Hot Flashes, Vaginal Dryness, Estrogen Deprivation Symptoms Intervention / Treatment: BEHAVIORAL: Text message management prompts Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Breast cancer * Female * Completed primary breast cancer treatment * Age \<=45

Study Objectives RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme. Conditions: Brain and Central Nervous System Tumors Intervention / Treatment: DRUG: irinotecan hydrochloride, DRUG: temozolomide, PROCEDURE: adjuvant therapy, RADIATION: radiation therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision * No gliomas graded less than glioblastoma multiforme * No recurrent malignant gliomas * No tumor foci below the tentorium or beyond the cranial vault * Study therapy must begin ≤ 5 weeks after surgery PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * At least 8 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL\* * Hematocrit ≥ 30%\* NOTE: \*Transfusion allowed Hepatic * Bilirubin ≤ 0.5 mg/dL * ALT or AST ≤ 2 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL * BUN ≤ 25 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-barrier contraception during and for 2 months after study participation * No AIDS * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder * No other major medical illness or psychiatric impairment that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent sargramostim (GM-CSF) Chemotherapy * No other concurrent chemotherapy Endocrine therapy * Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry Radiotherapy * No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields * Prior radiotherapy for stage T1 glottic cancer allowed Surgery * See Disease Characteristics * Recovered from prior surgery Other * No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan * Concurrent non-enzyme-inducing antiepileptic drugs allowed

Study Objectives The purpose of this study is to help determine the best treatment plan for women with PCOS who are overweight or obese and experiencing significant symptoms of depression and anxiety. Specifically, the investigators are attempting to see if there is a difference between cognitive behavioral therapy in combination with nutritional counseling in improving mood symptoms, response to stress, and risk factors for heart disease compared to nutrition counseling alone. The investigators hypothesize that combined treatment with Cognitive Behavioral Therapy (CBT) and nutritional counseling will be more beneficial. Conditions: Polycystic Ovary Syndrome (PCOS) Intervention / Treatment: BEHAVIORAL: Cognitive Behavioral Therapy, BEHAVIORAL: Nutrition Counseling Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Diagnosis of Polycystic Ovary Syndrome (PCOS) * Overweight or obese (BMI 27-50) * Screen positive for symptoms of depression Exclusion Criteria: * Smoking 5 or more cigarettes per day * Severe depression/anxiety warranting immediate treatment * Actively participating in a weight loss program * Taking medications to control cholesterol or diabetes * On hormonal therapy (must be discontinued to be eligible) * Pregnancy or planning to become pregnant during the study period * Inability to commute to Philadelphia for weekly study sessions

Study Objectives RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cetuximab may help cisplatin and fluorouracil work better by making tumor cells more sensitive to the drugs. It may also make tumor cells more sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin, fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I (closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of 11/3/2008) or stage III anal cancer. Conditions: Anal Cancer Intervention / Treatment: BIOLOGICAL: cetuximab, DRUG: cisplatin, DRUG: fluorouracil, RADIATION: radiotherapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

INCLUSION CRITERIA: * Histologically confirmed anal canal or perianal (anal margin) squamous cell carcinoma * Stage I-IIIB (closed to accrual as of 11/3/2008) * Stage II (T3, N0 only), IIIA, or IIIB * Tumors of nonkeratinizing histology, such as basaloid, transitional cell, or cloacogenic histology, allowed * No well-differentiated stage I anal margin cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Hemoglobin ≥ 10 g/dL * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance \> 60 mL/min * Bilirubin ≤ 2 times ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times ULN * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No other malignancies except nonmelanomatous skin cancer * Prior malignancies must be in remission for ≥ 5 years * Patients with a known risk factor for human immunodeficiency virus (HIV) infection must undergo HIV testing within 90 days before study entry AND must be HIV negative by antibody detection, culture, or quantitative assay of plasma HIV ribonucleic acid (RNA) EXCLUSION CRITERIA: * Presence of the following conditions within the past 6 months: * Active infection * Uncontrolled diabetes * New York Heart Association class II-IV congestive heart failure * Cerebrovascular accident * Transient ischemic attack * Uncontrolled hypertension * Unstable angina * Myocardial infarction * History of rheumatic disorders, irritable bowel syndrome, or inflammatory bowel disease * Known HIV positivity * Known risk factors for HIV infection * Prior radiotherapy or chemotherapy for this malignancy * Prior pelvic radiotherapy * Prior potentially curative surgery (i.e., abdominal or peritoneal resection) for anal cancer * Pregnant or nursing

Study Objectives The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer. Conditions: Jaundice, Pancreatic Cancer Intervention / Treatment: DRUG: G17DT Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: Masking: NONE

Inclusion Criteria: * Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection. * If patients were jaundiced, bilirubin had to be \>80 μmol/L. * Male or female patients over 18 years of age. * World Health Organization (WHO) performance status of 0 to 2. * Patients with a life expectancy of at least 8 weeks. * Patients must have given written informed consent. Exclusion Criteria: * Patients undergoing a potentially curative resection. * Jaundiced patients with a bilirubin value \<80 μmol/L. * Patients not considered fit for endoscopic or percutaneous biliary stenting. * Patients receiving any other anti-cancer therapy. * History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix. * Females who were pregnant, planning to become pregnant, or who were lactating. * Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study. * Previous G17DT treatment. * Haematological indicators: Haemoglobin (Hb) \<10.0 g/dL. White cell count (WCC) \<4.0×109/L. Platelets \<100×109/L.

Study Objectives The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following Taxotere based regimens. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Irofulven, DRUG: Prednisone, DRUG: Mitoxantrone, DRUG: Capecitabine, DRUG: Irofulven Location: Chile, United States, Croatia, Canada, Romania, Brazil, France, Russian Federation, Peru Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: To be included in the study, patients must meet the following criteria: 1. Cancer of the prostate confirmed by a biopsy sample. 2. 18 years of age or older. 3. Disease must have spread beyond the prostate as proven by chest x ray, abdominal and pelvic computed tomography (CT) scan, bone scan or clinical examination. 4. At least one prior hormonal treatment with documented disease progression during hormone therapy. 5. One previous line of chemotherapy that included Taxotere® (as monotherapy or in combination). This could be in addition to estramustine single agent therapy. 6. Disease progression during prior Taxotere-based therapy or within 3 months of discontinuing. 7. Recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery. 8. Recovered from any toxic effects associated with other investigational drugs, if applicable. 9. Signed informed consent obtained prior to initiation of any study-specific procedures or treatment. Exclusion Criteria: Patients cannot participate in the study if any of the following apply: 1. Unable to use prednisone. 2. Prior treatment with irofulven, capecitabine (Xeloda), continuous/protracted infusion 5-FU (5-fluorouracil) (infusion duration greater than or equal to 24 hours), other fluoropyrimidines or mitoxantrone. 3. Ongoing treatment with a corticosteroid at a prednisone-equivalent dose \> 10 mg/day. 4. More than 1 prior treatment with either 153Sm or 89Sr, or radioisotope treatment within 8 weeks prior to entering this study. 5. Initiation of treatment with bisphosphonate agents (e.g., pamidronate, etidronate) within 2 months of entering the study. Pre-existing treatment with bisphosphonate agents is to be continued during this study. 6. Treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period. Please note: There are additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail and answer any questions. Patients can then decide if they wish to participate.

Study Objectives Our study was planned as a prospective controlled randomized study. The study was started after the ethics committee approval received from Dışkapı Yıldırım Beyazıt Training and Research Hospital. (23.08.2021 118/01). Two groups of patients were planned in parallel. In the treatment of pilonidal sinus disease, in patients operated on with the fistulotomy and curettage technique, one group was followed up with classical dressing, while the other group was followed up with PRP (platelet-rich-plasma) and classical dressing. Wound infection, hematoma, length of hospital stay, recurrence, pain in the first postoperative week, and time to complete epithelialization of the wound (in days) were evaluated between the two groups. Conditions: Pilonidal Disease, Pilonidal Sinus Intervention / Treatment: OTHER: Platelet rich plasma Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * patients diagnosed with pilonidal sinus disease in our hospital between November 2021 and November 2022 Exclusion Criteria: * Patients under 18 years of age * Acute pilonidal abcess * Recurrent disease * Anemic patients (Hg \< 10 mg/dl) * Thrombocytopenic patients (Plt˂10⁶/ml) * Patients with a history of radiotherapy-chemotherapy * Diabetes Mellitus * Patients using steroids

Study Objectives This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with combination chemotherapy may kill more tumor cells. Conditions: Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Metastatic Childhood Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Untreated Childhood Rhabdomyosarcoma Intervention / Treatment: BIOLOGICAL: Cixutumumab, DRUG: Cyclophosphamide, BIOLOGICAL: Dactinomycin, DRUG: Doxorubicin Hydrochloride, DRUG: Etoposide, DRUG: Ifosfamide, DRUG: Irinotecan Hydrochloride, OTHER: Laboratory Biomarker Analysis, DRUG: Temozolomide, DRUG: Vincristine Sulfate Liposome Location: Canada, Australia, United States, New Zealand Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must be eligible for, and enrolled on D9902 prior to enrollment on ARST08P1 * Patients with newly diagnosed, biopsy-proven metastatic rhabdomyosarcoma or ectomesenchymoma (stage IV, clinical group IV) are eligible for this study; patients with stage IV, clinical group IV RMS with parameningeal and paraspinal primary tumors, including those with intracranial extension (ICE) are eligible for ARST08P1; ICE is defined by contrast magnetic resonance imaging (MRI) showing that the primary tumor touches, displaces, invades, distorts, or otherwise causes signal abnormality of the dura in brain or spinal cord in contiguity to the primary site; ICE is also presumed to exist if the cerebrospinal fluid (CSF) cytopathology is positive for tumor at diagnosis * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * No prior chemotherapy or radiotherapy except for use of corticosteroids or emergent radiation therapy; patients requiring emergency radiation are eligible * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73m\^2 OR maximum serum creatinine based on age/gender as follows: * 0.4 mg/dL (for patients 1 to 5 months of age) * 0.5 mg/dL (for patients 6 to 11 months of age) * 0.6 mg/dL (for patients 1 year of age) * 0.8 mg/dL (for patients 2 to 5 years of age) * 1.0 mg/dL (for patients 6 to 9 years of age) * 1.2 mg/dL (for patients 10 to 12 years of age) * 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age) * 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients \>= 16 years of age) * Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, unless there is evidence of biliary obstruction by the tumor * Shortening fraction \>= 27% by echocardiogram (ECHO) OR ejection fraction \>= 50% by radionuclide angiogram * Absolute neutrophil count (ANC) \>= 750/uL; abnormal blood counts are permissible if there is bone marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma * Platelet count \>= 75,000/uL; abnormal blood counts are permissible if there is bone marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma * Sexually active patients of childbearing potential must agree to use effective contraception during therapy (Pilots 1 and 2) and for at least 3 months after the last dose of IMC-A12 (Pilots 1) Exclusion Criteria: * Female patients who are pregnant are not eligible * Female patients who are breastfeeding are not eligible; female patients who are lactating must agree to stop breastfeeding to participate in this study * Patients receiving growth hormone therapy are not eligible * Patients with known type I or type II diabetes mellitus are not eligible for enrollment on Pilot 1 * Patients with evidence of uncontrolled infection are not eligible * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Study Objectives This is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases. Conditions: Basal Cell Carcinoma, Keratosis Palmaris et Plantaris, Psoriasis Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Patients with widespread involvement (e.g. psoriasis patients with 10 percent or more of body surface area involved) or with severe, recalcitrant localized involvement with a cutaneous disorder (e.g. keratoderma palmaris et plantaris). Patients (and parents of patients who are less than 18 years old) must be advised of presently available alternative forms of therapy. Patient must be available for and agreeable to regular follow up examinations in the clinic for clinical evaluation, blood tests, diagnostic x-rays and possibly skin biopsies. The patient (and parent, guardian, or surrogate where appropriate) must give written informed consent after protocol, including its limitations and risks, are thoroughly discussed with the patients (and parents). Patients who have multiple skin cancers because of xeroderma pigmentosum (XP). No patients with persistently abnormal (SGOT or SGPT greater than 3 times the upper limit of normal) liver function tests. No patients with persistent pre-treatment hypertriglyceridemia (greater than 300 mg/dl). No patients with persistently abnormal (creatinine greater than 3 times the upper limit of normal) renal function tests. No patients with presence of a significant neurological, musculoskeletal or other internal medical disorder which may be aggravated by the addition of retinoid therapy. Patient must not be pregnant or anticipate such an event. Because of the long-term storage of etretinate, a known teratogen, fertile women who may be treated in this protocol, must have skin disease that is severe and recalcitrant to all other standard modalities. These women must also use an effective form of contraception (oral contraceptives or an intrauterine device) while on treatment and at least for 3 years post treatment. No patients with chronic intake of excessive dietary vitamin A (more than 25,000 iu/day).

Study Objectives The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab Conditions: Colorectal Cancer Intervention / Treatment: DRUG: BMS-908662, DRUG: BMS-908662, DRUG: Cetuximab Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies. * Histologic or cytologic confirmation of the diagnosis. * Eastern Cooperative Oncology Group (ECOG) ≤ 1 * Adequate organ \& marrow function. Exclusion Criteria: * Uncontrolled or significant cardiovascular disease. * Phase 2: Prior therapy with a RAF inhibitor.

Study Objectives The aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of MPM patients extracting the DNA and genotyping for the TSER polymorphism. Conditions: MALIGNANT PLEURAL MESOTHELIOMA Intervention / Treatment: Location: Italy Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * MPM diagnosis * Availability of tumor tissue to perform analysis Exclusion Criteria : * Other primary diagnosis * No archival tissue available

Study Objectives This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants with locally recurrent or metastatic breast cancer. The study consists of three parts. Part 1 (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab), Part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or bevacizumab or trastuzumab) and Part 3 (pictilisib will be administered in combination with letrozole). Part 1 and Part 2 consists of two stages; a dose escalation stage and a cohort-expansion stage. Conditions: Breast Cancer Intervention / Treatment: DRUG: Bevacizumab, DRUG: Pictilisib, DRUG: Letrozole, DRUG: Paclitaxel, DRUG: Trastuzumab Location: United States, Italy, Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease * Adequate organ and bone marrow function as assessed by laboratory tests * Evaluable disease or disease measurable per RECIST * Agreement to use an effective form of contraception for the duration of the study Exclusion Criteria: * History of malabsorption syndrome or other condition that would interfere with enteral absorption * Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents * Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, radiotherapy, or hormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study treatment * Uncontrolled current illness * Active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis) * Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus * Known HIV infection * New York Heart Association (NYHA) Class II or greater congestive heart failure * Active ventricular arrhythmia requiring medication * Pregnancy, lactation, or breastfeeding * Known significant hypersensitivity to study drugs or excipients * History of arterial thromboembolic disease within 6 months of first study treatment * No more than two prior chemotherapy regimens for metastatic disease

Study Objectives This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Erlotinib, DRUG: Pertuzumab Location: Spain, United Kingdom, Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adult patients greater than or equal to 18 years of age * Histological confirmation of non-small cell lung cancer (NSCLC) * Locally advanced or metastatic disease * Failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease * Life expectancy of more than or equal to 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Baseline Left Ventricular Ejection Fraction (LVEF) of greater than or equal to 50% * A negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential * Availability of histological Formalin-Fixed, Paraffin-Embedded (FFPE) tumor tissue Exclusion Criteria: * Prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study Day -8 * Prior treatment with any agent which targets growth factors or their receptors * Patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy * History of clinically significant cardiovascular disease * History or evidence of central nervous system metastases * Treatment with any investigational drug within 28 days of the start of the study (day -8) * Prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent

Study Objectives This study is a double-blind, placebo-controlled, randomized clinical trial to determine whether IVIG is effective in improving motor scores in patients with myasthenia gravis and worsening weakness. Conditions: Myasthenia Gravis Intervention / Treatment: DRUG: Intravenous ImmuneGlobulin Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: DOUBLE

Inclusion Criteria: * age \> or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and worsening weakness Exclusion Criteria: * age \<18; severe myasthenia gravis requiring intensive care admission; change in immunosuppresive medication in previous 3 months; patients with severe bulbar weakness at risk for aspiration and respiratory failure; patients with other serious underlying medical conditions (renal failure, congestive heart failure); unwilling to provide informed consent.

Study Objectives The purpose of the study is to investigate the safety of the investigational drug called cirmtuzumab when given for a duration of 6 to 12 months. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that is on the surface of chronic lymphocytic leukemia (CLL) cells. This blocks growth and survival of the CLL cells. ROR1 is rarely expressed on healthy cells so this drug should target the cancer cells. Cirmtuzumab is considered experimental because its use is not approved by United States (US) Food and Drug Administration (FDA). Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease the number of CLL cells, the investigators do not know if this will work in humans. Therefore, the goal of this study is to see if cirmtuzumab is safe and tolerable in study participants when given for a duration of 6 to 12 months. Conditions: Chronic Lymphocytic Leukemia Intervention / Treatment: DRUG: cirmtuzumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Clinical and phenotypic verification of B cell CLL and measurable disease. Immunophenotyping of the leukemic cells (blood or marrow) must demonstrate a monoclonal (or light chain positive) B cell population with immunophenotype consistent with CLL (e.g., co-expressing CD19 and CD5). * Recovered from toxic effects attributed to UC-961 to grade 1 levels, or baseline. * Must have measurable disease, including one of the following: * absolute lymphocyte count greater than 5000/uL * lymphadenopathy greater than 1.5 cm in longest dimension * splenomegaly * bone marrow biopsy with residual CLL cells, or resultant bone marrow dysfunction * Women of childbearing potential must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961. * Subjects must have an ECOG performance status of 0-2. * Adequate hematologic function * Adequate renal function * Adequate hepatic function * Adequate coagulation tests Exclusion Criteria: * Pregnant or breast-feeding women * May have had intervening therapy since completion of initial UC-961 dosing, but excluding the following: * Within 7 days of UC-961 restart, or 5 half-lives (if known), whichever is shorter: small molecule tyrosine kinase inhibitor (eg: ibrutinib, idelalisib, AVL-292, IPI-145); * Within 28 days of UC-961 restart: chemotherapy (e.g., purine analogues, alkylating agents), corticosteroids, radiation therapy, or participation in any other investigational drug treatment (besides UC-961); * Within 56 days of UC-961 restart: previous UC-961 dosing; * Within 56 days of UC-961 restart: monoclonal antibody therapy directed against CLL (e.g., rituximab, ofatumumab, obinutuzumab, alemtuzumab). * Current infection requiring parenteral antibiotics. * Active infection with HIV, HBV, or HCV. * Concurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ, prostate cancer, or localized non-melanoma skin cancer). * Known central nervous system (CNS) involvement by malignancy. * Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia. * Uncompensated hypothyroidism (defined as TSH greater than 2x upper limit of normal not treated with replacement hormone). * Presence of more than 55% pro-lymphocytes in peripheral blood. Patients with Richter's transformation are not excluded. * Insufficient recovery from surgical-related trauma or wound healing. * Impaired cardiac function including any of the following: * Myocardial infarction within 6 months of starting study drug; * A past medical history of clinically significant ECG abnormalities; * Other clinically significant heart disease (e.g. uncontrolled congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).

Study Objectives RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help identify biomarkers related to cancer. It may also help doctors learn how patients respond to treatment. PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic lymphocytic leukemia who were treated on clinical trial ECOG-2997. Conditions: Leukemia Intervention / Treatment: GENETIC: cytogenetic analysis, OTHER: flow cytometry, OTHER: fluorescence activated cell sorting, OTHER: immunoenzyme technique, OTHER: laboratory biomarker analysis Location: Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Stored frozen viable cells from patients with chronic lymphocytic leukemia treated on clinical trial ECOG-2997 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Study Objectives This pilot study seeks to evaluate the feasibility of measuring the proximal effects of concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic target molecules in Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, this study proposes to evaluate the extent to which CRT induces the differential expression of components along two critical, and potentially interdependent, molecular pathways: the arachidonic acid and epidermal growth factor receptor (EGFR) signaling pathways. Conditions: Head and Neck Squamous Cell Carcinoma Intervention / Treatment: BIOLOGICAL: the arachidonic acid and EGFR signaling pathways and their interaction in HNSCC tumorigenesis, Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Untreated HNSCC (\> Stage I) amenable to transoral biopsy. * Scheduled for concurrent CRT (Cisplatin or Carboplatin/5-FU based) as definitive primary treatment * Older than 18 years of age. * Understand and sign informed consent. Exclusion Criteria: * Any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study. * Breast-feeding, pregnancy or of childbearing potential (including those women who are less than two years post menopausal) and unable to confirm adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since last menses. * History of chronic inflammatory disease (e.g. ulcerative colitis, Crohn's disease, rheumatoid arthritis or pancreatitis). * Corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays. * NSAID (including celecoxib) or aspirin (\> 81 mg/day) use within 1 week of enrollment. * Investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.

Study Objectives The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status in breast cancer survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence these outcomes, in particular, through reduction in fear of breast cancer recurrence and associated perceived stress. Both objectives were studied at the critical transition time immediately following completion of surgical, radiation and/or chemotherapy therapy for breast cancer. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Mindfulness-Based Stress Reduction Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * 21 years old or older * Diagnosed with Stage 0, I, II, or III breast cancer * Undergone lumpectomy and completed adjuvant radiation and/or chemotherapy (end of treatment to 18 months post-treatment) * Ability to read and speak English at the 8th grade level to respond to the survey questions Exclusion Criteria: * Advanced stage (IV) breast cancer * History of mastectomy * Current psychiatric diagnosis * Recurrent treatment for prior breast cancer

Study Objectives Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. Therefore it could be very important and clinically relevant to know if ZD1839 is capable of eliminating occult tumour cells circulating in the blood of breast cancer patients Conditions: Breast Cancer Intervention / Treatment: DRUG: ZD1839 Location: Greece Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Provision of written informed consent * Histologically or cytologically confirmed breast cancer * Metastatic breast cancer (stage IIIB and IV) * Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. There should be at least one month between end of chemotherapy treatment and trial entry. * ER+ve patients should have received adjuvant hormonal treatment * Detection of CK-19 mRNA positive cells in the blood by real time PCR despite the previous administration of chemotherapy and if appropriate hormonal therapy * Aged 18 years and over * Paraffin-embedded tissue available for tumour histology (EGFR testing, ER, PgR, Her-2-neu testing) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 * Patients willing to undergo regular detection of circulating occult tumour cells in the blood by immunocytochemistry and/or RT-PCR * Life expectancy of at least 12 weeks Exclusion Criteria: * Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies) * Known severe hypersensitivity to ZD1839 or any of the excipients of this product * Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia) * Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR) * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 3 times the ULRR. * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study * Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy * Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort * Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment

Study Objectives To understand efficacy of axitinib in recurred or metastatic adenoid cystic carcinoma Conditions: Recurrent ACC, metastaticACC, Unreaectable ACC Intervention / Treatment: DRUG: Axitinib, OTHER: Observation Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: 1. Histologically confirmed adenoid cystic carcinoma 2. Local, locally-advanced or metastatic disease documented as having shown progression on a scan (CT, MRI, MIBI scan) or X-ray taken \>9 months prior to baseline compared to a previous image. Progression must be documented according to RECIST 1.1 criteria. 3. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent 4. Presence of at least one measurable target lesion for further evaluation according to RECIST 1.1 criteria 5. 18 years or older 6. ECOG performance status 0, 1 7. Adequate organ function * ANC ≥ 1500/ μL * Platelets ≥100,000/ μL * Hemoglobin ≥ 9.0 g/dL * Serum creatinine ≤1.5 x ULN * Serum bilirubin ≤1.5 x ULN * AST, ALT, ≤3.0 x ULN (regardless of liver metastasis) 8. A patient with the willingness to comply with the study protocol during the study period and capable of complying with it 9. A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages. Exclusion Criteria: 1. A patient with no measurable disease 2. Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry) 3. A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding 4. A pregnant or lactating patient 5. A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential) 6. A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study 7. A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of skin, early gastric cancer and cervical carcinoma in situ. 8. A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications. 9. A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months. 10. A patient with organ transplantation requiring immunosuppressive therapy

Study Objectives A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to: 1. reduce fasting glucose levels 2. reduce androgen hormone levels 3. improve sex steroid binding, and 4. improve lipids (fatty substances in the blood) Conditions: Polycystic Ovary Syndrome Intervention / Treatment: DRUG: Metformin, DRUG: Oral Contraceptive Pills (Yasmin), BEHAVIORAL: Lifestyle Modification, DRUG: placebo Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Menstrual irregularity defined as cycle length \> 45 days * Overweight as BMI \> 25 * Clinical evidence of hirsuitism or acne * Testosterone \> 50ng/dL Exclusion Criteria: * History of diabetes mellitus * History of Cushing's disease * History of hyperprolactinemia * Untreated hypo or hyperthyroidism * History of adrenal hyperplasia * Significant renal impairment * Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study * Exercise \> 10 hours per week

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer. Conditions: Lung Cancer Intervention / Treatment: DRUG: temozolomide, DRUG: Temozolomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: Stage IIIB, IV, or recurrent non-small cell lung cancer for which no curative therapy with surgery, radiation, or combination chemoradiotherapy exists Chemotherapy-naive patients: No prior chemotherapy OR At least 6 months since prior adjuvant, induction, or radiosensitizing chemotherapy OR Previously treated patients (closed to accrual 8/01): No more than one prior chemotherapy regimen for relapsed or metastatic disease AND/OR No more than one prior adjuvant, induction, or radiosensitizing chemotherapy within the past 6 months Measurable or evaluable disease CNS metastases allowed (previously treated metastases cannot be only site of measurable disease) No brain metastases with prior whole body irradiation PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other active invasive malignancies PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy Surgery: See Disease Characteristics

Study Objectives PRIMARY STUDY OBJECTIVES * To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients: 1. Patients post first line therapy 2. Patients with relapsed/refractory disease who are bortezomib-naïve * To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma. SECONDARY STUDY OBJECTIVES * To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect \> 10 x 106 CD34+ cells/kg in \< 7 collections (for both subsets of multiple myeloma patients). * To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients). Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Bortezomib, DRUG: dexamethasone, DRUG: liposomal doxorubicin, DRUG: cyclophoshamide, DRUG: filgrastim Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subject must voluntarily sign and understand written informed consent. * Confirmed diagnosis of multiple myeloma as specified by the SWOG criteria and is detailed in Appendix I. * Measurable disease as defined the following: 1. For patients post induction therapy, any measurable paraprotein in the serum or urine and/or any plasmacytoma present on physical exam or imaging. 2. For patients with relapsed/refractory disease, \> 0.5 g/dL serum monoclonal protein, \> 0.1 g/dL serum free light chains, \> 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s). * Age \> or = than 18 years at the time of signing the informed consent form. * Karnofsky performance status\> or =70% (\>60% if due to bony involvement of myeloma). * Group A (post-induction therapy)- patients who have received only one prior treatment regimen (eg VAD, Thal/Dex, BLT-D, MP, BiRD, or DVd) with at least 20 patients having received a Revlimid based regimen or Group B(\>1st line of therapy)- patients with relapsed/refractory multiple myeloma who have received two or more prior treatment regimens . * If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study and must use effective contraception throughout the course of the study. * Life expectancy \> 12 weeks. * Absolute neutrophil count (ANC)\> or = 1500 cells/mm3 (\> or = 1000 for patients with bone marrow biopsy displaying \> 50% involvement by myeloma) * Platelets count \> or = 50,000/mm3 (\> or = 30,000 for patients with bone marrow biopsy displaying \> 50% involvement by myeloma) * Hemoglobin \> 9.0 g/dL * Serum SGOT/AST \<3.0 x upper limits of normal (ULN) * Serum SGPT/ALT \<3.0 x upper limits of normal (ULN) * Serum creatinine \< 2.5 mg/dL or creatinine clearance \> 40ml/min * Serum total bilirubin \< 1.5 x ULN * Patients must have a MUGA scan with LVEF \>50% Exclusion Criteria: * Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan. * Prior treatment with bortezomib. * Peripheral neuropathy of \> Grade 2 as defined by CTCAE Version 3.0 (see Appendix II) * History of allergic reactions to compounds containing mannitol, bortezomib, conventional formulation of doxorubicin HCL or the components of DOXIL. * Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years. * NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, serious uncontrolled cardiac arrhythmia or myocardial infarction within 6 months. * Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. * Known HIV or hepatitis A, B, or C positivity * Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program. * Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis). * No prior anti-myeloma therapy within 2 weeks of treatment initiation.

Study Objectives The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery. Conditions: Breast Cancer, Prostate Cancer, Colon Cancer Intervention / Treatment: OTHER: Blood test Location: France Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient is aged between 18-75 * Patient must weigh \>40kg * The patient will receive adjusted carcinological surgery * Indication of curative surgery * The patient has already undergone tumoral biopsy prior to surgery * The patient has stage M0 cancer of either colon (right or left colonic adenocarcinoma), prostate (adenocarcinoma) or breast (infiltrating carcinoma) Exclusion Criteria: * The subject is in a period of exclusion determined by a previous study * The patient is under safeguard of justice * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is pregnant, parturient or breast feeding * Chronic alcoholism * The patient has received radiotherapy or chemotherapy periopratively * Cancer other than colon, breast or prostate * The patient has currently or in the past, had a cancerous lesion * Neo-adjuvant therapy (immunotherapy, radiotherapy, chemotherapy) * Emergency cancer surgery

Study Objectives This phase II trial is studying the side effects and how well giving radiation therapy together with bevacizumab, paclitaxel, and carboplatin works in treating patients with unresectable stage IIIB or stage IV non-small cell lung cancer at high risk for hemoptysis caused by bevacizumab. Radiation therapy uses high-energy x-rays to kill tumor cells. It may also prevent hemoptysis caused by bevacizumab. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with bevacizumab and chemotherapy may kill more tumor cells Conditions: Adenosquamous Cell Lung Cancer, Drug/Agent Toxicity by Tissue/Organ, Hemoptysis, Squamous Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer Intervention / Treatment: BIOLOGICAL: bevacizumab, DRUG: paclitaxel, DRUG: carboplatin, RADIATION: radiation therapy Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)\* meeting the following criteria: * Squamous cell or mixed squamous-nonsquamous histology with predominant squamous component (≥ 50% squamous) with a primary, unresected endobronchial lesion * No small cell component * Centrally located primary tumor, defined by the following: * Primary tumor of any T stage within or touching the zone of the proximal bronchial tree * Zone is defined as a 3-dimensional volume with a perimeter of 2 cm in each direction around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi) * Any disease within this volume must not invade blood vessels determined by a contrast-enhanced CT scan evaluation of the entire thorax with thin slices (≤ 5 mm) through the area of central tumor bulk (i.e., no evidence of vessel invasion radiological evaluation) * Stage IIIB (with malignant pleural effusion) or stage IV disease * Patients with stage IIIB NSCLC without an effusion are eligible if they are not candidates for combined modality therapy with curative intent (i.e., radical chemoradiotherapy) * At high risk for bevacizumab-associated hemoptysis * Hemoptysis estimated as between 2.5 mL and 10 mL (largest volume of single episode of hemoptysis) in the past 2 months * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * No known brain metastases by contrast-enhanced CT scan or gadolinium-enhanced MRI of the brain * No clinical or radiologic evidence of an existing or impending spinal cord compression * ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% * Life expectancy \> 6 months * WBC ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Creatinine normal OR creatinine clearance ≥ 50 mL/min * INR \< 1.5 * aPTT ≤ 1.5 times ULN * No serious medical conditions, including any of the following: * Unstable angina * Myocardial infarction or stroke (cerebrovascular accident or transient ischemic attack) within the past 6 months * Congestive heart failure * Active cardiomyopathy * Unstable ventricular arrhythmia * Symptomatic peripheral vascular disease * Active peptic ulcer disease * Uncontrolled psychotic disorders * Serious infections * Other medical conditions potentially aggravated by treatment * No social situation that would preclude study compliance * No other active malignancy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment * No history of bleeding diathesis or coagulopathy associated with elevated risk of bleeding * No uncontrolled hypertension (i.e., resting blood pressure consistently higher than systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg with or without antihypertensive medication), history of labile hypertension, or history of poor compliance with antihypertensive medication * No clinically significant proteinuria (24-hour urine protein \< 1,000 mg) * No serious or nonhealing wound, ulcer, or bone fracture * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days * No significant traumatic injury within the past 28 days * No history of known allergy or reaction attributed to compounds of similar chemical or biological composition to bevacizumab, such as Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies, Cremophor EL®, or other agents used in study treatment * No pre-existing peripheral neuropathy \> grade 1 * No prior thoracic radiotherapy * At least 12 months since prior chemotherapy * No prior chemotherapy for advanced disease * No prior therapy with angiogenesis, vascular endothelial growth factor (VEGF), or VEGF-receptor inhibitors * Cyclooxygenase-2 inhibitors as a noncancer therapy allowed * At least 28 days since prior and no concurrent major surgery or open biopsy * At least 12 months since prior anticancer therapy for any other malignancy except basal cell carcinoma of the skin, localized prostate cancer, or in situ carcinoma of the cervix * At least 10 days since prior therapeutic anticoagulants or therapeutic thrombolytic agents * No concurrent aspirin (\> 325 mg/day) or antiplatelet agents, including dipyridamole, ticlopidine, clopidogrel bisulfate, or cilostazol * Other concurrent nonsteroidal anti-inflammatory drugs allowed * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer agents or therapies * Steroids for pain, anorexia, or quality of life allowed

Study Objectives This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of tumor injections of INXN-2001 given in combination with different doses of INXN-1001. Conditions: Melanoma Intervention / Treatment: BIOLOGICAL: INXN-2001, DRUG: INXN-1001 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Males or females of all races ≥ 18 years of age, who have provided written informed consent prior to completing any study specific procedure. * Unresectable Stage III or Stage IV melanoma arising from any site other than ocular melanoma. * A minimum of 2 accessible nonvisceral lesions (shortest diameter ≥1 cm) or palpable tumor-involved lymph nodes (shortest diameter ≥1.5 cm). * ECOG performance status of 0 or 1 (Appendix 1). * Adequate bone marrow, liver, and renal function. * An expected survival of at least approximately 6 months. * Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate less than 5% per year) from the screening visit through 28 days after the last dose of study drug. Exclusion Criteria: * Any prior anti-cancer therapy or investigational agent within 28 days prior to the first dose of study drug. (NOTE: For the expansion cohort ONLY, if subjects received ipilimumab, a 90-day washout period since last dose of ipilimumab is required. If subjects received other immunomodulating therapies (eg, anti-PD1 antibodies), the medical monitor should be contacted and an evaluation will be made.) * Clinically significant infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks of the first dose of study drug. * History of HIV infection. * Active autoimmune disease requiring steroids (\>10 mg prednisone or comparable) or other immunosuppressive therapy (e.g., methotrexate, etc.). * Documented symptomatic brain metastases. Screening for brain lesions by CT or MRI is not required for all potential subjects; however, if there are any neurological signs or symptoms consistent with brain metastases, then a brain CT or MRI should be performed as clinically indicated. * Any medications that induce, inhibit or are substrates of CYP450 3A4 within 7 days prior to the first dose of study drug. * Prior history of hematopoietic stem cell transplant or organ allograft. * Other concurrent clinically active malignant disease, with the exception of other cancers of the skin. * Females who are nursing or pregnant. * Subjects who have a history of hypersensitivity that may relate to any component of the study drugs, e.g. to benzoic acid since INXN-1001 contains two benzene rings. * Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.

Study Objectives The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Core Exercise Promotion Intervention Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer * \<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months * Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods * Willing to wear the ActiGraph monitor during assessment periods * Access to internet to complete REDCap survey assessments Exclusion Criteria: * Non-English speaking/not able to read English * Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+) * Currently pregnant * History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium) * Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8) * Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener) * Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener

Study Objectives The ProSpace™ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the ProSpace System to reduce the radiation dose delivered to the anterior rectum. ProSpace is a balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time. Conditions: Prostate Cancer Intervention / Treatment: DEVICE: ProSpace, OTHER: Control Location: Netherlands, United States, Israel, United Kingdom, Portugal, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Be at least 18 years of age * Have been histologically diagnosed with invasive adenocarcinoma of the prostate, at clinical stage T1-T3 (as determined by a biopsy taken within 9 months of the screening visit) * Be scheduled for radiation therapy (XRT) by means of IMRT Exclusion Criteria: * Any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years * Prior radical prostatectomy * Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer * Prior radiotherapy to the pelvis, including brachytherapy * History of prior surgery involving the rectum or anus * Prior surgical procedure involving the peri-rectal and/or peri-prostatic area

Study Objectives To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental and oral surgeons (dental oral management group) and an observation group (brushing instruction only group) in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer. Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: Oral management, DRUG: Everolimus Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Female patients with a histological diagnosis of breast cancer (regardless of histological subtype of breast cancer). 2. Diagnosis of metastatic or recurrent breast cancer satisfies either of the below. 1. Distant metastasis present that is inoperable at time of first examination (Stage IV, 3.1 Clinical stage classification) 2. Progression of distant metastasis or recurrence of breast cancer after treatment (after surgery and after treatments prior to and after surgery) 3. Histologically confirmed diagnosis of ER-positive breast cancer 4. Postmenopause 5. Any of the below conditions indicating resistance to aromatase inhibitor therapy. The aromatase inhibitor therapy need not be the most recent therapy. 1. Recurrence during ongoing adjuvant therapy with an aromatase inhibitor, or recurrence within 12 months after adjuvant therapy with an aromatase inhibitor 2. Progression during ongoing aromatase inhibitor therapy for advanced breast cancer, or progression within 1 month after ending aromatase inhibitor therapy 6. Any number of chemotherapy (anti-neoplastic drugs) are allowed since diagnosis of metastatic or recurrent breast cancer 7. Aged ≥20 years 8. PS of 0-1. (ECOG scale). 9. Previous treatment (including adjuvant therapy) satisfies all the conditions below. 1. Hormone therapy: At least 7 days have elapsed from the last administration of hormonal therapy. 2. Radiotherapy: At least 14 days have elapsed from the last irradiation. 10. Organ function (within 4 weeks before enrollment) satisfies all the conditions below. 1. Neutrophil count (band cells + segmented cells) of ≥1,500/mm3, or white blood cell count of ≥3,000/mm3 2. Platelet count of ≥100,000/mm3 3. Total bilirubin of ≤2.5 × ULN 4. AST (GOT) and ALT (GPT) of ≤2.5 × ULN 5. Serum creatinine of ≤1.5 × ULN 11. Cardiac function satisfies either of the below. 1. No cardiac disorder: No fatigue, palpitation, shortness of breath, or anginal pain during everyday activities as confirmed by interview. 2. Has a cardiac disorder that does not limit movement, patient is confirmed to experience no fatigue, palpitation, shortness of breath, or anginal pain during everyday activities, and this health status is deemed to be maintained during treatment. 12. Informed consent is obtainable from the subject herself in documented form using the Consent Form. Exclusion Criteria: 1. Edentulous jaw (in both upper and lower jaws) 2. Occurrence of oral mucositis within 1 month prior to randomization 3. Chemotherapy used within 1 month prior to randomization 4. Exemestane monotherapy (this exclusion criterion is not met if ≥3 months has elapsed since the last exemestane treatment) as most recent therapy 5. Previous mTOR inhibitor treatment (everolimus, etc.) 6. Interstitial pneumonia or pulmonary fibrosis. 7. Received drug treatment known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) (See Table 4.1.2.1 and 4.1.2.2 for lists of prohibited concomitant drugs). 8. Positive result of HBs antigen, HBc antibody and/or HBs antibody. 9. HCV infection or a history of HCV infection. 10. History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation. 11. Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a cancer-free period of less than 5 years prior to randomization). Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer. 12. Overexpression of HER2 (Her2/neu, Erb B2), and the condition is considered to be indicated for trastuzumab (herceptin®) treatment (when the state of HER2 expression is unknown, the patient is not excluded, but is treated as eligible). In other words, patients that satisfy any of the below conditions will be excluded. At either the primary or the metastatic lesion: 1. Strongly positive, "3+" by HER2 IHC. 2. Positive "+" by FISH 13. Brain metastasis that requires treatment for intracranial hypertension or emergency irradiation of the brain. 14. Extensive liver metastasis, or lymphangitic lung metastasis with accompanying dyspnea. 15. Pleural effusion, ascites, or pericardial effusion that requires emergency treatment. 16. Concurrent and active infectious disease. 17. With uncontrolled diabetes mellitus or currently receiving insulin therapy. 18. Difficulty to participate in this study due to mental illness or psychiatric symptoms. 19. With another reasons recognized as inadequate to participate in this study by doctors.

Study Objectives The purpose of this study is to compare the recurrence rate following total clearance of external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications per week for 4 weeks) followed by ablative therapy (laser or electrocautery therapy) with that from just ablative therapy treatment alone. Conditions: Genital Warts Intervention / Treatment: DRUG: Imiquimod, OTHER: vehicle cream Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Subjects with at least 1 visible genital or perianal wart * Total wart area 1 to 40 square centimeters. Exclusion Criteria: * Pregnant or lactating women * Known other sexually transmitted disease * Evidence of a clinically significant immunodeficiency * Evidence of unstable cardiovascular, pulmonary, hematological, hepatic, renal, endocrine, collagen vascular, neurological or gastrointestinal abnormality or disease. * Treatment within the 4 weeks prior to the Randomization Visit with any of the following systemic or topical treatments: interferons, interferon inducers, immunomodulators, immunosuppressive drugs, antiviral drugs (except for systemic acyclovir, valacyclovir and famciclovir), cytotoxic drugs, investigational drugs, or any drugs known to have major organ toxicity.

Study Objectives The unilateral transverse rectus abdominis musculocutaneous (TRAM) flap is a major operation widely used for breast reconstruction. It is hypothesized that this surgery has the potential risk of weakening the abdominal wall because it disrupts the integrity of the rectus abdominis muscle (RA), therefore, alters the insertion of the oblique muscles and the biomechanical relationship between the RA muscle and adjacent structures. The purposes of this study were to examine the effects of the TRAM flap surgery on muscle size of abdominal muscles, strength and endurance of trunk muscles, strength and endurance of core stability, as well as the effects of therapeutic exercises on it in post-mastectomy women underwent TRAM surgery. Conditions: Breast Neoplasms Intervention / Treatment: BEHAVIORAL: Abdominal muscle training Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Healthy adults * Their age should be ranged between 30 - 60 years 2. TRAM flap surgery patients * at least 6 months after the MS pedicled TRAM flap surgery Exclusion Criteria: 1. Healthy adults * a history of injury resulting in an inability to perform activities of daily living * scoliosis or spinal surgery * neurological, neuromuscular, rheumatological or systemic diseases 2. TRAM flap surgery patients * tumor distant metastasis * a history of injury resulting in an inability to perform activities of daily living * scoliosis or spinal surgery * neurological, neuromuscular, rheumatological or systemic diseases

Study Objectives While cord blood transplants have been performed safely in elderly patients, many still relapse. The investigators propose to intensify the preparative regimen for this patient group in an attempt to decrease relapses, and combine this with an ex vivo expanded Umbilical Cord Blood (UCB) unit. Conditions: Hematologic Malignancies Intervention / Treatment: BIOLOGICAL: StemEx Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Ages 55-73 * Patients will have one of the following malignancies: * Acute myelogenous leukemia (AML) deNovo in first CR with adverse cytogenetic abnormalities, M0, M6, M7 subtypes, extramedullary disease in remission or high CD34+ disease (\> 50%) * AML in early relapse (5-10% blasts on bone marrow aspirate or biopsy), or beyond CR-1 with no circulating blasts * AML at any time if resulting from a previous myelodysplasia * Acute lymphocytic leukemia or lymphoblastic lymphoma (ALL) in first CR with adverse prognostic features: t (9; 22), extra medullary disease, or mature B cell phenotype * Acute lymphoid leukemia or lymphoblastic lymphoma in early relapse (5- 10% blasts on aspirate), or beyond CR-1 * Acute Undifferentiated Leukemia or biphenotypic leukemia in CR1 or CR2 * Transfusion dependent myelodysplastic syndrome (MDS) or refractory anemia with excess blasts (RAEB) or RAEB-in transition, CMMOL, or any myelodysplasia with 7q-, 5q-, 7-, 5- or resulting from prior anti cancer therapy. * Relapsed Non-Hodgkin's Lymphoma (NHL), including those that have relapsed after an autologous marrow/blood stem cell transplant * Chronic lymphocytic leukemia (CLL) patient who has had fludarabine and either failed or relapsed. Prior autologous transplant patients are eligible. * Patients with adequate organ function and performance status criteria * Subject must have at least one or the following back-up stem cell sources in case of engraftment failure: * Subject is willing to undergo BM harvest or peripheral blood progenitor cells (PBPC) collection for use in case of engraftment failure (when clinically applicable). * Subject has a second CBU as a possible back up. * Subject's haploidentical family member has been identified and agreed (by signing a written informed consent) to donate hematopoietic stem cells in case of engraftment failure. * Evaluation by social service/psychologist * Subject signs the written informed consent after being aware of the nature of the subject's disease and willingly consents to the treatment program after being informed of alternative treatments, potential risks, benefits and discomforts. * Ability to understand and agree to compliance with strict evaluation, isolation,and medication schedules * Designated primary care giver. * Dental evaluation/treatment completed. * ENT evaluation/treatment completed. * All patient who survive to day 90 are eligible for measurement of T and B cell function and lymphocyte subset numbers to determine immune reconstitution post UCB transplantation with or without StemEx® Exclusion Criteria: * Patient with suitable related donor as defined per institutional guidelines * Chemotherapy resistant or active AML, ALL, AUL, biphenotypic leukemia * AML evolved from myelofibrosis * MDS with 20% or greater bone marrow blasts at pre-transplant workup. Patients may receive therapy and if in remission, are eligible * Prior allogeneic hematopoeitic stem cell transplant at any time * Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except for hydroxyurea) * Uncontrolled bacterial, fungal or viral infection at the time of study enrollment * Seropositive or NAT positive for HIV, HTLV-1 and Hepatitis C * Subjects with signs and symptoms of active central nervous system (CNS) disease * Females who are pregnant or breastfeeding * Allergy to bovine proteins or to aminoglycoside antibiotics (e.g. gentamicin) or to any product, which may interfere with the treatment. * Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research tests. * Enrolled in another clinical trial or received an investigational treatment during the last 30 days, unless approved by the primary investigator.

Study Objectives this is a cross sectional intervention study to investigate the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy. This study hypotheses there is improvement in stoma output in PHGG if compare with control. There are two groups of subjects in this study. Conventional group (CG) will include retrospective historical data (those subjects with post-operative ileostomy) from Jan 2016 to June 2019. Intervention group (PHGG) will be subjects with ileostomy which involves prospective intervention by giving partial hydrolyzed guar gum upon start orally. Data on stoma output (volume \& consistency), length of hospital stay, readmission within 30-days discharged and dietary intake will be recorded in data collection form. Conditions: Rectal Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: PHGG, OTHER: conventional care Location: Malaysia Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Cancer patients with ileostomy * At least 18 years of age * Malaysian Exclusion Criteria: * Not cancer patients with ileostomy * Patients who participate in other study at the same time * Vulnerable subjects * Palliative patients * Patient has fistula

Study Objectives RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see how well it works in treating patients with stage IIIB non-small cell lung cancer that can be removed by surgery. Conditions: Lung Cancer Intervention / Treatment: DRUG: cetuximab, DRUG: cisplatin, DRUG: docetaxel, RADIATION: Radiotherapy, PROCEDURE: Surgery Location: Switzerland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Squamous, adeno, large cell, or poorly differentiated disease * Stage IIIB disease (T4N0-3M0 or T1-4N3M0) according to 6th TNM classification * Assessed by bronchoscopy and PET-CT scan within 42 days of registration * No malignant pleural or pericardial effusion, invasion of the aorta, esophagus, myocardium, or supraclavicular * No scalene nodes N3 * No stages IIIB disease defined only by satellite lesions in the same lobe * Lymph node staging done by mediastinoscopy (or EBUS) in N+ disease on PET-CT scan (SUV above mediastinum background SUV) or CT (size \> 10 mm in the smallest diameter) within 42 days of registration * Fine needle aspiration biopsy must be done by EBUS, TBNA, or VATS if lymph nodes are not accessible by mediastinoscopy (ATS nodes #5/6) * Mediastinoscopy is mandatory for suspicion of T4 tumor invading the trachea on PET-CT and CT scan in N-disease * Measurable disease assessed by contrast-enhanced CT-scan within 28 days of registration * Tumor tissue available for translational research (no cytology) * Resectable disease based on a multidisciplinary tumor board decision * No brain metastasis (confirmed by MRI within 42 days of registration) PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Platelet count ≥ 100 x 10\^9/L * Neutrophil count ≥ 1.5 x 10\^9/L * Bilirubin normal * AST ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Creatinine clearance ≥ 60 mL/min * FEV1 and DLCO ≥ 80% OR exercise test peak V02 \> 75% or 20 mL kg\^-1 min\^-1 (for pneumonectomy) * Exercise test peak V02 ≥ 35% and ≥ 10 mL kg\^-1 min\^-1 with predicted postoperative FEV1 and DLCO ≥ 30% (for resection less than pneumonectomy \[resection up to calculated extend according to ESTS/ACCP guidelines\]) * Ejection fraction \> 45% assessed by echocardiography * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after completion of study therapy * Must be compliant and geographically proximal for proper staging and follow-up * No previous malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer * No psychiatric disorder precluding understanding of information on trial-related topics and giving informed consent * No preexisting peripheral neuropathy \> grade 1 * No ischemia or relevant dysfunction revealed by noninvasive stress testing (stress radionuclide myocardial perfusion imaging or dobutamine stress echocardiography) for patients with a history of ischemic heart disease or any other relevant cardiovascular condition * No unstable cardiac disease requiring treatment, congestive heart failure or angina pectoris even if medically controlled, significant arrhythmia, or myocardial infarction within the past 3 months * No serious underlying medical condition that, at the judgment of the investigator, could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease, uncontrolled diabetes, or uncontrolled infection) * No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs * No absolute contraindications for the use of corticosteroids as premedication PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the chest * No pretreatment with any cytostatic therapy * No concurrent corticosteroids, except for prophylactic medication regimen prior to treatment or treatment of acute hypersensitivity reactions or chronic treatment (initiated \> 6 months prior to trial entry) at low-dose (\< 20 mg methylprednisolone or equivalent) * No concurrent drugs contraindicated for use with the trial drugs * At least 30 days since prior and no other concurrent experimental drugs or other anticancer therapy on another clinical trial

Study Objectives This research will examine the effectiveness of calcitriol in treating bone loss in women who are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women. Conditions: Breast Cancer Intervention / Treatment: DRUG: Calcitriol Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Must be female. * Must have pathologically confirmed incident, primary invasive breast cancer. * Must be awaiting surgical resection. * Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended. * Must provide informed consent. * Must be willing to discontinue use of calcium and/or vitamin D supplements other than multivitamin supplementation. * Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of \< 10.2mg/dl. Exclusion Criteria: * Subjects with life-threatening conditions that would preclude them from breast cancer treatment including: chronic cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease. * Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol. * Patients with a previous history of any other cancer except non-melanomous skin cancer within the past 5 years. * Patients with impaired renal function (CRCL \< 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years. * Patients with hypercalcemia (corrected serum CA \> 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity. * Patients currently taking calcium supplements or aluminum-based antacids must immediately discontinue their use if they are to enroll in the study. * Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study. * Patients with a known sensitivity to calcitriol. * Women who are pregnant or lactating. * Women on antiresorptive drugs (e.g. bisphosphonates) within the past year. * Women currently using oral contraception. * Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran). * Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.

Study Objectives Postmenopausal women who have hormone receptor positive breast cancer are typically treated with aromatase inhibitor medications, which substantially decrease the amount of estrogen produced by their bodies. These medications are fairly well tolerated, but can cause aches and pains which can be quite severe in some cases. People experience pain differently. Estrogen appears to play a role in how we experience pain. Therefore, decreasing estrogen levels may lead to more pain in some women than others. The goal of this study is to evaluate perception of pain in women with breast cancer, and to determine if differences in pain perception lead to more aches and pains in some women treated with aromatase inhibitors. In this study, we plan to enroll 55 women with breast cancer who are starting treatment with an aromatase inhibitor. Participants will undergo testing to evaluate their perception of pain, and will also complete a set of questionnaires. Testing will be conducted before starting aromatase inhibitor therapy, as well as after 3 and 6 months of therapy. We will investigate whether pre-existing differences in pain perception lead to different amounts of pain during aromatase inhibitor therapy. Conditions: Breast Cancer, Pain, Arthralgia Intervention / Treatment: DRUG: Anastrozole, DRUG: exemestane, DRUG: letrozole Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Female gender * Postmenopausal, age 21 or greater * Stage 0-III estrogen receptor and/or progesterone receptor positive breast cancer who will be receiving a standard dose of letrozole, anastrozole, or exemestane * Performance status 0-2 * Willing to sign the consent form Exclusion Criteria: * Average pain \>=8/10 over the past 24 hours * Peripheral sensory neuropathy grade 2 or higher * Personal history of schizophrenia, or suicidal ideation or attempt within the past 2 years * Thumbnail abnormalities on either hand that are likely to alter pain perception during testing

Study Objectives Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purpose of this study was to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy in a pilot randomized controlled design. Baseline data for all participants were ascertained via medical records and patient interview. This included demographic information, Union internationale contre le cancer-status (UICC-status), comorbidities and the results of blood samples. Outcomes were measured at admission. One study coordinator completed all assessments to enhance patient compliance. Body weight loss percentage was calculated via the individuals' body weight 6 months before (in retrospect) and the current body weight. Participants completed two questionnaires: The Multidimensional Fatigue Inventory and the Functional Assessment of Anorexia/Cachexia Therapy questionnaire. Six-Minute Walk Test was applied. To document changes in muscle force, strength of the functional muscle group for elbow flexion in supine position as well as of knee extension in sitting position (in each case right and left) was tested via hand-held dynamometry for isometric maximal muscle strength. Bioelectrical impedance analysis was executed to assess the adaption in body composition. The exercise intervention was undertaken in the hospitals department of physical and rehabilitation medicine and based on standardized but individualized training protocols. It consisted of a warm up period for 5 minutes on a bicycle ergometer or an upper body cycle with individual selectable wattage. A leg press, a latissimus pull-down and a chest press formed the three equipment supported core exercises. All exercises were performed with 8-12 repetitions and 3 sets. Conditions: Head and Neck Cancer, Cachexia; Cancer, Resistance Training Intervention / Treatment: OTHER: Exercise Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * planned inpatient or outpatient radiotherapy * ≥ 18 years of age * diagnosed state of cachexia (weight loss greater than 5 % over the past 6 months) or pre-cachexia (unintentional weight loss of 5 % or less of usual body weight during the last 6 months) Exclusion Criteria: * metastatic disease * severe neurological problems or other contraindications for resistance training

Study Objectives Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. Conditions: Uterine Fibroids Intervention / Treatment: DRUG: 12.5 mg Proellex, DRUG: 25 mg Proellex, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound. * Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain Exclusion Criteria: * Post-menopausal women, as defined as one or more of the following: 1. six months or more (immediately prior to Screening visit) without a menstrual period, or 2. prior hysterectomy and/or oophorectomy * Subjects with documented endometriosis

Study Objectives This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene (BRCA1 or BRCA2)-mutated solid tumors and high grade serous ovarian, fallopian tube, or primary peritoneal cancer. Conditions: Fallopian Tube, Primary Peritoneal Cancer, Solid Tumors (e.g. Breast, Ovarian, Prostate, or Pancreatic) and Ovarian Intervention / Treatment: DRUG: ABT-767 Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subjects must have histological or cytological confirmation of locally advanced or metastatic solid tumor, and a documented Breast Cancer Gene 1 or 2 mutation, or high grade serous ovarian, fallopian tube, or primary peritoneal cancer. 3. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2 4. Subjects must have adequate hematologic, renal, and hepatic function as follows: a. Bone Marrow: Absolute neutrophil count (ANC ≥ 1,500/mm3 (1.5 ≥ 109/L); Platelets ≥ 100,000/mm3 (100 ≥ 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L) (hemoglobin unsupported by transfusion b. Subject has adequate renal function as demonstrated by serum creatinine value of ≤ 1.5 x the upper limit of normal (ULN) and either an estimated creatinine clearance value of ≥ 50 mL/min as determined by the Cockcroft-Gault formula or a creatinine clearance value of ≥ 50 mL/min/1.73 m2 based on a 24-hour urine collections c. Subject has adequate liver function as demonstrated by serum bilirubin ≤ 1.5 x ULN and Aspartate Aminotransferase (AST) and Alanine Transaminase (ALT) ≤ 2.5 ULN. For subjects with liver metastasis, AST and ALT \< 5 x ULN. Partial Thromboplastin Time (PTT) must be ≤ ULN and INR \< 1.5. - Subjects on anticoagulant (such as Coumadin) are allowed on study and will have PTT and International Normalize Ratio (INR) as determined by the Investigator. 5. Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of the study participation, and for 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to initiation of treatment and a negative urine pregnancy test on the first day of study drug administration. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Exclusion Criteria: 1. Expanded cohort only: Subject has previously received a poly (ADP-ribose) polymerase (PARP) inhibitor. 2. Subject has received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within a period of 28 days or 5 half lives (whichever is shorter) prior to Study Day 1. 3. Subject has known Central Nervous System (CNS) metastases. 4. Subject has unresolved toxicities from prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.0) grade 2 or higher clinically significant toxicity (excluding alopecia). 5. Subject has had major surgery within 28 days prior to Study Day 1. 6. Clinically significant uncontrolled condition(s) or any medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities. 7. Psychiatric illness/social situation that would limit compliance with study requirements. 8. Lactating or pregnant female.

Study Objectives The purpose of this study is to determine whether metformin may improve pregnancy rates, and decrease miscarriage rates and complications of pregnancy, such as toxemia and gestational diabetes, in women with polycystic ovary syndrome (PCOS). Conditions: Polycystic Ovary Syndrome, Miscarriage, Infertility, Toxemia, Gestational Diabetes Intervention / Treatment: DRUG: metformin Location: Finland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: 1. age \< 40 years at entry 2. BMI \> 19 kg/m2 3. Infertility lasting \> 1 year 4. Criteria for PCOS are as defined by ESHRE/ASRM: at least two of the following findings: * polycystic ovaries shown by vaginal ultrasonography (more than 12 subcapsular follicles of 3-8 mm diameter in one plane of the ovary) * oligomenorrhea or amenorrhea * clinical manifestations of hyperandrogenism such as a hirsutism score of \> 7 according to Ferriman and Gallwey (Ferriman \& Gallwey 1961)and/or an elevated serum testosterone level (\> 2.7 nmol/l). Exclusion Criteria: 1. diabetic subjects 2. alcohol users 3. active liver disease (ALAT \> +2 SD the upper normal value i.e.\> 100IU/l) 4. hormonal drugs 5. past or present cardiac failure (NYHA I-IV) 6. liver or renal failure (S-Creatinine above the normal value ie.124 umol/l) 7. pregnancy or lactation 8. hypersensitivity to metformin

Study Objectives Prostate cancer is the most common non-cutaneous cancer in men. Patients with recurrent or metastatic prostate cancer are treated with androgen-deprivation therapy, often termed castration therapy. While the short and medium term benefits of castration are clear in relation to therapeutic efficacy in patients with prostate cancer, it is now appreciated that the resulting hypogonadism associated with castration is responsible for adverse consequences or metabolic syndrome that include increase in body mass index (BMI) and fat mass, hyperinsulinemia and insulin resistance, hyperlipidemia, reduced lean body mass (LBM) and muscle strength, osteoporosis, sexual dysfunction, poor quality of life and higher cardiovascular mortality. Lower testosterone levels in men independently predict the development of metabolic syndrome. Low testosterone levels in men are associated with insulin resistance and diabetes. Metformin is commonly prescribed for the treatment of type II diabetes because it lowers both glucose and insulin levels. Studies show preliminary evidence that metformin might have both antineoplastic and chemopreventative activity. Castration therapy decreases insulin sensitivity, adversely alters lipid profiles and results in weight gain, and it may be associated with a greater incidence of diabetes and cardiovascular disease. Little is known about the optimal strategy to mitigate the adverse metabolic effects of castration in men with prostate cancer. The rationale for using metformin in castrated men with advanced prostate cancer stems from the observation that castration therapy is associated with the metabolic syndrome, hyperinsulinemia and insulin resistance. Furthermore, reports that hyperinsulinemia stimulates insulin receptor expression on prostate cancer leading to tumor growth and development of castrate resistant prostate cancer suggest metformin through its activation of the AMPK-LKBI pathway reduces liver gluconeogenesis secondarily decreasing insulin levels may circumvent tumor growth and resistance to castration therapy. More importantly, evidence that metformin inhibits the mTOR pathway implicates an added therapeutic benefit as an anti-cancer agent. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Placebo, DRUG: Metformin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: (Eligible subjects must meet one of the inclusion criteria 1-3 and all of items 4-6) 1. Men with metastatic prostate cancer that require castration therapy with either using an LHRH analogue or surgical castration are eligible. Complete androgen blockade using anti-androgen therapy prior to castration or up to 4 weeks following castration therapy is permitted to prevent disease flare. Thereafter anti-androgen therapy may continue or be discontinued based on treating physicians preference. OR 2. Any men with prostate cancer who are candidates for castration therapy despite no evidence of definite metastatic disease including patient with biochemical failure or 'rising PSA' are also permitted to enter study provided castration therapy is planned for a minimum of a year. Patients with biochemical failure prior to enrolment should have also have already received appropriate salvage therapy. Men with prostate cancer who have already started castration therapy are also permitted to enter study provided castration therapy was initiated within one month of study entry. OR 3. Men with prostate cancer previously treated with castration therapy for management of localized prostate cancer in the adjuvant setting or in combination with radiation therapy are permitted to enter study provided they currently have known metastatic disease and have non-castrate testosterone levels (Testosterone \> 50 ng/dL). 4. An ECOG performance status of 0-2. 5. Patients will need to have documentation of metastatic disease in bone and/or soft tissue, and a baseline PSA of ≥ 5 ng/ml. If patients have already had castration therapy, their baseline PSA value will be reflective of the value prior to castration. Patients with biochemical failures, with rising PSA (baseline PSA does not need to be ≥ 5 nglml to be eligible), without metastatic disease are also eligible if castration therapy is indicated for minimum of 7 months and for these patients any PSA value is permitted. 6. Patients must have provided informed consent, be willing to have blood specimens taken, and exhibit no severe other medical or psychiatric problems. Exclusion Criteria: 1. Patients with severe medical or psychiatric diseases are INELIGIBLE. (Patients with stable chronic diseases such as high cholesterol or hypertension ARE eligible.) Examples of problems that would make patients INELIGIBLE include severe heart failure, or hypoxia due to severe lung disease. 2. Patients with clinical or biochemical evidence of renal failure or liver failure are INELIGIBLE. Creatinine and bilirubin needs to be less than or equal to 1.3\~up per limit of normal (ULN), and ASTIALT less than or equal to 2.5 x ULN unless liver metastasis is present then up to 5 X ULN permitted). 3. Patients already receiving metformin or anti-diabetic medications are INELIGIBLE. 4. If any patient develops symptomatic diabetes requiring drug therapy, he must receive such a therapy, which may include metformin. This must be documented, and the patient will not continue on the study. 5. Patients with important infections requiring antibiotics are INELIGIBLE, but patients who acquire minor infections while on the study may remain on the study. 6. Alcohol abuse problems make patients INELIGIBLE. Patients need to be consuming less than or equal to 14 units of alcohol weekly. 7. Patients with history or evidence of lactic acidosis or metabolic acidosis will be excluded.

Study Objectives RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer. Conditions: Breast Cancer Intervention / Treatment: BIOLOGICAL: trastuzumab, OTHER: laboratory biomarker analysis, OTHER: pharmacological study Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic disease, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, CT scan, MRI scan, or ultrasound) or scintigraphically confrimed * Evaluable disease * Beginning first-line metastatic treatment with trastuzumab (Herceptin®) with or without chemotherapy * Primary tumor must overexpress HER2 (IHC 3+ OR IHC 2+ and FISH+ OR FISH+) * Hormone receptor status not specified * No brain metastasis PATIENT CHARACTERISTICS: * Menopausal status not specified * Life expectancy \> 3 months * Able to undergo cardiotoxicity evaluation every 4 months by measuring LVEF via an isotopic method or ultrasound with systematic registration * No chronic uncontrolled disease * No heart failure * No respiratory failure or hypoxemia * No history of another primary cancer except for basal cell carcinoma of the skin * No severe uncontrolled infection * No psychological incapacity PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Study Objectives This phase I trial is studying the side effects and best dose of bortezomib when given together with decitabine in treating patients with acute myeloid leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with decitabine may kill more cancer cells. Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: DRUG: bortezomib, DRUG: decitabine, OTHER: pharmacological study, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of acute myeloid leukemia (AML), meeting one of the following criteria: * Relapsed or refractory disease (≥ 18 years of age) * Previously untreated disease (≥ 60 years of age) * Secondary AML or therapy-related AML allowed * No granulocytic sarcoma as the sole site of disease * No active or relapsed CNS disease * No advanced malignant solid tumors * ECOG performance status 0-2 * Life expectancy \> 6 months (if patient has co-morbid illness) * Total bilirubin \< 2.0 mg/dL * AST and ALT \< 2.5 times upper limit of normal * Creatinine \< 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Patients with HIV infection are eligible provided the following criteria are met: * No history of AIDS * Has a sufficiently high CD4 count (\> 400/mm³) * Has low HIV viral loads (\< 30,000 copies/mL plasma) * Does not require anti-HIV therapy * No uncontrolled active infection * No history of allergic reactions attributed to compounds of similar chemical or biological composition to decitabine or bortezomib that are not easily managed * No hypersensitivity to boron or mannitol * No concurrent uncontrolled illness including, but not limited to, any of the following: * Symptomatic congestive heart failure * Unstable or uncontrolled angina pectoris * Serious cardiac arrhythmia * Myocardial infarction within the past 6 months * New York Heart Association class III-IV heart failure * Severe uncontrolled ventricular arrhythmias * Acute ischemia or active conduction system abnormalities by ECG * No serious medical or psychiatric illness or social situation that would preclude participation in this study * No pre-existing neuropathy ≥ grade 2 * No other serious neurologic toxicity that would significantly increase the risk of complications from bortezomib therapy * Recovered from prior therapy (toxicity \< grade 2) * More than 14 days since prior investigational agents * More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy * Prior decitabine or azacitidine for myelodysplastic syndromes (MDS) or AML allowed * More than 6 months since prior decitabine, azacitidine, or bortezomib * No concurrent palliative radiotherapy * No other concurrent investigational agents * No other concurrent direct anti-leukemia therapy

Study Objectives Rationale: Polycystic liver disease (PLD) is a rare disorder characterized by \>20 fluid-filled hepatic cysts. Polycystic livers are present in the combination with renal cysts as a manifestation of autosomal dominant polycystic kidney disease (ADPKD), or isolated in the absence of renal cysts as autosomal dominant polycystic liver disease (ADPLD or PCLD). PLD patients are confronted with symptoms caused by the mass effect of their polycystic liver every day for the rest of their life. There is no standard therapeutic option for symptomatic PLD patients. Current options are fairly invasive or their efficacy is only moderate. Preliminary data in our research lab have shown that ursodeoxycholic acid (UDCA) inhibited the proliferation of polycystic human cholangiocytes in vitro through the normalization of the intracellular calcium levels in cystic cholangiocytes. The investigators also found that daily oral administration of UDCA for 5 months to polycystic kidney disease (PCK) rats, an animal model of ARPKD that spontaneously develops hepato-renal cystogenesis, resulted in inhibition of hepatic cystogenesis. The investigators hypothesize that UDCA is an effective therapeutic tool in reducing liver volume in PLD. Objective: First, to demonstrate whether UDCA-therapy is effective in reducing total liver volume in PLD patients. Second, the investigators want to assess if UDCA modifies quality of life. Finally, the investigators want to assess safety and tolerability. Study design: International, multicenter, randomized, controlled trial Study population: 34 subjects (18 ≤age ≤ 80 years) suffering from symptomatic polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts on CT-scan and liver volume of ≥ 2500. Symptomatic is defined as Eastern Cooperative Oncology Group- Performance Score (ECOG-PS) ≥ 1 and having at least three out of ten PLD symptoms. Intervention: The patients will be randomized (1:1) into two groups. One group of patients will receive 15-20mg/kg/day UDCA for 24 weeks. The other group will receive standard care. Main study endpoint: Proportional change of total liver volume in UDCA treated patients versus non treated patients, as assessed by CT at baseline and 6 months. Conditions: Polycystic Liver Disease, Polycystic Kidney, Autosomal Dominant Intervention / Treatment: DRUG: Ursodeoxycholic Acid Location: Spain, Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 18 ≤ age ≤ 80 years * Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts * Total liver volume ≥ 2500 mL * Symptomatic defined as ECOG-PS ≥ 1 (2), and having at least three out of ten PCLD symptoms: * Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements. Exclusion Criteria: * Use of oral anticonceptives or estrogen supplementation * Use of UDCA in 3 months before baseline * Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control. * Intervention (aspiration or surgical intervention) within six months before baseline * Treatment with somatostatin analogues within six months before baseline * Renal dysfunction (MDRD-Glomerular filtration rate\< 30 ml/min/1.73m2) * Patients with a kidney transplant * Hypersensitivity reaction to UDCA or patients with galactose-intolerance, lactase deficiency or glucose-galactose malabsorption * Acute cholecystitis or frequent biliary colic attacks * Acute stomach or duodenal ulcers * Inflammation of small intestine or colon * Use of drugs that can interact with UDCA, such as colestyramine, aluminium hydroxide or cyclosporin * Enrolment in another clinical trial of an investigational agent while participating in this study * History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study * Mental illness that interferes with the patient ability to comply with the protocol

Study Objectives This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC). Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: Location: Jordan Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Informed consent form signature * Jordanian male and female participants greater than or equal to (\>=) 18 years of age * Histologically confirmed NSCLC * Not participating in a study that involves an investigational agent within 30 days prior to enrollment Exclusion Criteria: * Other primary malignancy * Fine needle aspiration samples

Study Objectives Phase 1 study evaluating the safety and tolerability of YS-ON-001 in patients with advanced solid tumors who have limited available treatment options, and exploratory evaluation of the pharmacological effect and efficacy of YS-ON-001. The study will be conducted in two parts: dose escalation and cohort expansion Conditions: Cancer Intervention / Treatment: BIOLOGICAL: YS-0N-001 Location: Singapore Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Life expectancy ≥ 3 months * Patient with histologically or cytologically proven advanced (unresectable) or metastatic solid tumor who have failed standard therapies or are intolerant to standard therapies.Part 1: Any advanced or metastatic solid tumor patient Part 2: Selected tumor types including cytological or histologically diagnosed breast cancer and liver cancer * Patients with adequate bone marrow function, with absolute neutrophil count (ANC) \>1,500/mm3, platelet count \>100,000/mm3, and hemoglobin \> 10 g/mm3 * Patients with adequate kidney function, with serum creatinine ≤1.5 X upper limit of normal (ULN) * Patients with adequate liver function, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN, total bilirubin ≤1.5x ULN ; For patients with liver metastasis, AST, ALT ≤5x ULN, Total bilirubin ≤1.5x ULN * Patients with adequate coagulation function, with activated partial thromboplastin time (aPTT) ≤1.5x ULN * Female patients, if of childbearing potential, must have a negative serum pregnancy test within 72 hours prior to the date of the first dose of study medication. * Female patients of childbearing potential and male patients must agree to use adequate methods of contraception with their partner starting with the screening visit up to 4 weeks after the last dose of study therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Exclusion Criteria: * Known uncontrolled seizures, central nervous system disorders, or loss of cognitive ability due to mental illness * Pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study. * Patient is currently receiving or has received systemic corticosteroids within 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. The following use of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops or local injections (e.g., intra-articular). * Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). * Known serious, uncontrolled medical conditions that in the opinion of the investigator, will render it unsafe for the patient to receive the study therapy * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Patient has not recovered (i.e., to ≤ Grade 1 or to baseline) from radiation- and chemotherapy-induced adverse events (AEs) or administration of colony-stimulating factors (including granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) or recombinant erythropoietin) within 3 weeks prior to the first dose of study drug. * Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational drug within 4 weeks prior to the first dose of study drug. * Received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half-life of the most recent therapy prior to study Day 1, whichever is shorter. Note: palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment will be allowed. * Patient has not recovered adequately (≤ Grade 1) from AEs and/or complications from any major surgery prior to starting therapy. Patient has received a vaccine within 7 days of planned start of study therapy. * Known hypersensitivity to YS-ON-001 components or excipients * Known unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction that occurred within a year, severe arrhythmia that required drug treatment, liver disease, kidney disease and metabolic diseases) * Known history of splenectomy * Known history of chronic alcohol or drug abuse within 6 months * PI assessment of subject's lack of willingness to participate and comply with all requirements of the protocol * Any other finding which, in the opinion of the PI would significantly increase the risk of having an adverse outcome from participating in this protocol.

Study Objectives The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy. Conditions: Breast Cancer, Anemia Intervention / Treatment: DRUG: Darbepoetin Alfa, DRUG: Recombinant Human Erythropoietin Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection

Study Objectives The investigators would study about impact of the administration of probiotics in the intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by quantitative real time PCR. The investigators believe that patients who use probiotic preoperative would provide cytokine profile less inflammatory than those of the control group. Conditions: Colorectal Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: Saccharomyces boulardii Location: Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * if he or she were older than 18 years * intended to undergo elective CRC resection at UFMG Hospital Exclusion Criteria: * Patients were excluded if they were not able to receive the probiotics seven days before the operation * if colon resection was not performed due to changes in operation strategy, or if they discontinued probiotic use on their own or * if they removed their consent.

Study Objectives This dose escalation and dose expansion study is to evaluate and characterize the tolerability and safety profile of single agent KN035 in Chinese adult subjects with unresectable advanced carcinoma. Conditions: Solid Tumors Intervention / Treatment: DRUG: KN035 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Main Inclusion Criteria for dose escalation study: * Subject is male or female ≥ 18 years and ≤ 70 years of age on the day of signing informed consent,and subject has voluntarily agreed to participate by giving written informed consent. * Subjects must have a histopathological diagnosis of any locally advanced or metastatic solid tumor, Subjects must have failed established standard medical anti-cancer therapies ( have disease progression after the therapies or be intolerant to the therapies) or Subjects refuse to standard therapies, or no effective treatment. * Measurable disease as defined by RECIST v1.1. * Subject must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Life expectancy ≥ 12 weeks. * Subject must have adequate hematologic and organ function. * Female subject of childbearing potential has a negative serum pregnancy test. * Female subjects of childbearing potential and male subjects with partner of childbearing potential should agree to keep abstinence (refuse to heterosexual intercourse) or use one or more methods of contraception of which the failure rate is less than 1% per year starting with the first dose of study drug through at least 6 months after the last dose of study therapy. Main Inclusion Criteria for dose expansion study: * Histologic confirmation of advanced hepatocellular carcinoma, disease not eligible for curative surgical and/or locoregional therapies, OR progressive disease after surgical and /or locoregional therapies. * At least one RECIST 1.1 measurable untreated lesion. All subjects must have at least one previously untreated, unidimensionally measurable lesion by contrast-enhanced spiral computed tomography (CT) ≥10 mm or contrast enhanced dynamic magnetic resonance imaging (MRI) scan ≥10 mm (malignant lymph nodes must be ≥15 mm on short axis). * Subject is male or female ≥ 18 years and ≤ 75 years of age on the day of signing informed consent,and subject has voluntarily agreed to participate by giving written informed consent. * Subject must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Cirrhotic status of Child-Pugh Class A. * Subjects are eligible to enroll if they have non-viral-HCC, or if they have HBV-HCC, or HCV-HCC defined as follows: i) HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or Chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA \< 104 copies/ml and must be on antiviral therapy. ii) HCV-HCC: Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody. * Life expectancy ≥ 12 weeks. * Subject must have adequate hematologic and organ function. Main Exclusion Criteria: * Subject Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy within 28 days of the first dose of study drug. * Subject has not recovered to CTCAE Grade 1 or better from the adverse events due to cancer therapeutics administered * Subject has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds (ms)), or a history of additional risk factors for torsade de pointes (TdP, e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or is using concomitant medications that prolong the QT/QTc interval. * Subject has had antineoplastic therapy within 4 weeks prior to the first dose of study therapy KN035. * Subject is, with one year of the time signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol). * Subjects with symptomatic ascites, pleural effusion or pericardial effusion. * Subject is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. * Subject has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging brain metastases and are off steroids for at least 7 days from first dose of KN035. * Subject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Subject has Leptomeningeal disease. * Subject previously had a severe hypersensitivity reaction to treatment with another mAb. * Subject has an active infection (CTCAE≥Grade 2) with 4 weeks of the first dose. * Subject is positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active hepatitis B (HBV surface antigen positive and HBV DNA ≥ 104 copies/ml)or hepatitis C or tuberculosis (HCV antibody positive and HCV-RNA≥ 103 copies/ml). * Subject has received or will receive a live vaccine within 4 weeks prior to the first administration of study drug. Addtional exclusion criteria for dose expansion study: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. * The patient accepted any anti-cancer therapy within 28 days prior to the first dose of study drug including surgery, radiotherapy, biotherapy, immunotherapy and/or locoregional therapy (eg: radiofrequency ablation \[RFA\], percutaneous ethanol \[PEI\] or acetic acid injection \[PAI\], cryoablation, high-intensity focused ultrasound \[HIFU\], transarterial chemoembolization \[TACE\], transarterial embolization \[TAE\], etc.) * Prior liver transplant or history of hepatic encephalopathy

Study Objectives This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Conditions: Stomach Neoplasms, Esophageal Neoplasms Intervention / Treatment: DRUG: Irinotecan, DRUG: Trastuzumab, DRUG: Oxaliplatin, DRUG: Leucovorin, DRUG: Fluorouracil Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Biopsy-proven and inoperable locally advanced, recurrent, or metastatic cancer of the esophagus, stomach, or gastro-esophageal junction. 2. Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, as ≥20 mm by chest x-ray, or ≥10 mm with calipers by clinical exam. 3. Prior single modality radiation therapy is allowed. 4. At least 18 years of age. 5. ECOG performance status ≤ 2 6. Normal bone marrow and organ function as defined below: 1. Absolute neutrophil count ≥ 1,500/mcl 2. Platelets ≥ 100,000/mcl 3. AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN 4. Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal 5. LVEF ≥ 50% 7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. 8. Ability to understand and willingness to sign an IRB approved written informed consent document (legally authorized representative is allowed). 9. Patients already receiving treatment with FOLFIRINOX +/- trastuzumab may participate in the study and have their data collected retrospectively if they met inclusion criteria at the start of therapy and sign consent for study participation moving forward. Exclusion Criteria: 1. Chemotherapy in the 6 months prior to registration. 2. Any active malignancy within 3 years that may alter the course of esophageal cancer (Apparently cured localized malignancy or advanced, but indolent malignancy with significantly more favorable prognosis are allowed) 3. Receiving any other investigational agents at the time of registration. 4. Known untreated brain metastases. These patients must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 5. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study. 6. Previous therapy for metastatic gastroesophageal cancer. Previous perioperative chemotherapy is allowed as long as the duration without treatment has been greater than 6 months.. 7. A history of congestive heart failure, transmural myocardial infarction, symptomatic valvular disease, or high-risk arrhythmia. 8. 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. 9. Pregnant and/or breastfeeding. Patient must have a negative urine pregnancy test within 14 days of study entry. 10. Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with trastuzumab. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.

Study Objectives The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer. The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB. Conditions: Bladder Cancer Intervention / Treatment: DRUG: Hexvix, OTHER: Standard white light cystoscopy Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder * Above 18 years * Written informed consent obtained Exclusion Criteria: * Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy). * Patient with porphyria. * Known allergy to hexyl aminolevulinate hydrochloride or a similar compound. * Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. * Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter). * Conditions associated with a risk of poor protocol compliance.

Study Objectives This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half will receive clomiphene citrate only. Conditions: Clomiphene Citrate Resistant Polycystic Ovary Syndrome Intervention / Treatment: DIETARY_SUPPLEMENT: vitamin E, DRUG: Metformin, DRUG: Clomiphene Citrate Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS 2. Age between 18 and 39 years. 3. Period of infertility \>1 years. 4. No treatment taken during the last 2 months. 5. Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance Exclusion Criteria: 1. History of pelvic surgery or infertility factor other than anovulation 2. Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations. 3. Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency. 4. Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date. 5. Male factor infertility (sperm count \< 5 million per milliliter, normal morphology \<4%). 6. Elevated serum prolactin, T.S.H and F.S.H. 7. Patients diagnosed with diabetes mellitus

Study Objectives Correlation between colposcopist findings and digital cervicography employing Gynescope system Conditions: Cervical Dysplasia Intervention / Treatment: DIAGNOSTIC_TEST: Digital cervicography Location: Israel Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: - Patients reffered for colposcopy Exclusion Criteria: Patient refusion

Study Objectives This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data. Conditions: Solid Tumours Intervention / Treatment: DRUG: AZD9291 tablet dosing, PROCEDURE: Pharmacokinetic sampling - AZD9291, PROCEDURE: Pharmacokinetic sampling - AZ5140 and AZ7550 Location: Korea, Republic of, Belgium, United States, Spain, France, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

For inclusion in the study as a patient with hepatic impairment, the following criterion must be met: 1. Patients must have stable chronic hepatic impairment for at least 2 weeks prior to Day 1, see Section 4.1.1. Patients with hepatic metastases and/or HCC are eligible for the study, providing the hepatic metastases or HCC are not the sole reason for any changes in liver function satisfying the criteria for mild or moderate hepatic impairment as defined by the Child Pugh criteria. Patients must have globally impaired hepatic function to participate in the study. For inclusion in the study as a patient with normal hepatic function, the following criteria must be met: 1. Negative result for serum hepatitis B surface antigen and hepatitis C antibody 2. Total bilirubin less than or equal to1.5 x institutional ULN, albumin and prothrombin time within normal limits and must not have ascites (unless related to disease under study) or encephalopathy. 3. AST and ALT less than or equal to2.5 x institutional ULN unless liver metastases are present in which case it must be less than or equal to5 x ULN. All patients must fulfil the following criteria: 1. Male or female, aged at least 18 years. 2. Histological or, where appropriate, cytological confirmation of any malignant solid tumour refractory or resistant to standard therapy or for which no suitable effective standard therapy exists. Tumours in which inhibition of the EGFR pathway is considered relevant by the Investigator are not mandated but are encouraged. 3. ECOG performance status less than or equal to2. 4. Patients must have a life expectancy of greater than or equal to12 weeks, as estimated at the time of screening. 5. Females should be using adequate contraceptive measures and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments; women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the postmenopausal range for the institution; documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation 6. Male patients should be willing to use barrier contraception, ie, condoms, until 6 months after last study drug is taken. Exclusion criteria: 1. Participation in another clinical study with an IP during the last 14 days (or a longer period depending on the defined characteristics of the agents used). 2. Treatment in the previous 3 months before dosing in this study with any drug known to have a well-defined potential for fulminant hepatotoxicity (eg, halothane and methotrexate). 3. Treatment with any of the following: an EGFR TKI w/in 8 days or approximately 5x half-life, whichever is the longer, of the first dose of study treatment; Any cytotoxic chemotherapy, investigational agents or other anticancer drugs w/in 14 days of the first dose of study treatment; Major surgery (excluding placement of vascular access) w/in 4 weeks of the first dose; Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment; Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) (Appendix H). All patients in Part B and continued access must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known potent inducer/inhibitory effects on CYP3A4 (Appendix H). 4. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy. 5. Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of the IP until final PK sample collection on Day 22. 6. Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment. 7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required. 8. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: ANCless than1.5x10.9/L; platelet count less than100x10.9/L; haemoglobinless than90 g/L; Creatinine greater than1.5 x institutional ULN concurrent with creatinine clearance less than50 mL/min (measured or calculated by Cockcroft-Gault formula); confirmation of creatinine clearance is only required when creatinine is greater than1.5 x institutional ULN. 9. Any of the following cardiac criteria: Mean resting corrected QT interval corrected for heart rate using Fridericia's correction factor (QTcF) greater than470 msec obtained from 3 ECGs; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, PR interval greater than250 msec; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval. 10. Patients unable to swallow oral medication or patients with GI disorders or significant GI resection likely to interfere with the absorption of AZD9291. 11. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 12. Women who are breastfeeding. 13. Patients with a known hypersensitivity to AZD9291 or any of its excipients. Patients with normal hepatic function should not have a history or presence of hepatic disease known to interfere with the absorption, distribution, metabolism or excretion of AZD9291. Patients with mild or moderate hepatic function should not enter if the following are fulfilled: 1. Patients with hepatic encephalopathy within the last 4 weeks prior to Day 1. 2. Fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period. 3. Presence of acute liver disease caused by drug toxicity or by an infection. 4. Severe portal hypertension or surgical porto-systemic shunts. 5. Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver. 6. Oesophageal variceal bleeding within the past 2 months. 7. Anticoagulant therapy with warfarin or related coumadine.NOTE: Preferred format includes lists of inclusion and exclusion criteria

Study Objectives This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: bevacizumab [Avastin], DRUG: carboplatin, DRUG: erlotinib [Tarceva], DRUG: paclitaxel Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * adult patients, \>=18 years of age; * stage IV non-squamous non-small cell lung cancer; * asymptomatic, untreated brain metastasis; * ECOG performance status 0-1. Exclusion Criteria: * previous treatment for brain metastasis; * history of migraine or epilepsy; * previous treatment with angiogenesis inhibitors; * for cohort 2, previous first line treatment with Avastin or Tarceva; * current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.

Study Objectives Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinctmurine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity. Conditions: Neoplasms, Breast Intervention / Treatment: Location: China Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * The patient is ≥ 30 years of age at the time the informed consent to screening has been obtained; * The patient has one of the following histologically confirmed breast cancer subtypes: Estrogen receptor and/or progesterone positive tumor; Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer; HER2-negative breast cancer. -- The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation): * Hemoglobin: Within normal range according to institutional standards; * Absolute leukocyte count: Within normal range according to institutional standards; * Absolute lymphocyte count: Within normal range according to institutional standards; * Platelet count: Within normal range according to institutional standards; * Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN); * Aspartate aminotransferase: ≤ 2.5 x ULN; * Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN; * Serum creatinine: 1.5 x ULN; * Calculated creatinine clearance: \> 50 mL/min . Exclusion Criteria: * The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion. * Diagnosis established by incisional biopsy. * Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol. * level 3 hypertension; * severe coronary disease; * myelosuppression; * respiratory disease; * brain metastasis; * chronic infections

Study Objectives The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol Conditions: Advanced Gastrointestinal Tumors Intervention / Treatment: DRUG: Minnelide™ 001 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

ELIGIBILITY CRITERIA: Inclusion Criteria: 1. Histologically or cytologically confirmed gastrointestinal (GI) carcinoma, which has progressed on standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy), for which effective therapy is not available or for which patients are not a candidate for or intolerant of such therapies. 2. Have one or more metastatic tumors measurable on CT scan or locally advanced measurable disease that has clearly progressed after prior treatment per RECIST criteria. 3. Male and female patients at least 18 years of age 4. Laboratory data as specified: * Hematology: ANC \>1500 cells/mm3, platelet count \> 150,000 cells/mm3 and Hemoglobin \> 9 g/dL * Hepatic: Direct bilirubin ≤1.5 X ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 X ULN. For patients with known liver metastases or liver neoplasms, then ALT or AST ≤ 5.0 X ULN is allowed * Renal: serum creatinine WNL or calculated creatinine clearance ≥ 50 mL/min/1.73m2 for patients with creatinine levels above institutional normal * Urinalysis: No clinically significant abnormalities * Coagulation: INR within normal limits, PTT within normal limits 5. Estimated life expectancy of at least 3 months 6. Karnofsky Performance ≥ 70% 7. A negative serum pregnancy test (if female) 8. For men and women of child-producing potential - willingness to employ appropriate contraceptive methods (including abstinence) during the study. 9. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments. Exclusion Criteria: 1. Women who are pregnant or nursing. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 2. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG. 3. Baseline QTc exceeding 450 msec (470 msec for females) using the Bazetts formula and/or patients receiving class 1A or class III antiarrythmic agents. 4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 5. Treatment with radiotherapy, chemotherapy or investigational therapy within 1 month (or 5 half lifes for cytotoxics) prior to study entry (6 weeks for nitrosoureas or Mitomycin C). 6. Known HIV, Hepatitis A, B or Hepatitis C infection 7. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor. 8. Participation in concurrent study of an investigational agent or device. 9. Unwillingness or inability to comply with procedures required in this protocol. 10. Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible.

Study Objectives This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: SNS-314 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Advanced solid tumor and that is measurable by a scan Exclusion Criteria: * Uncontrolled or untreated central nervous system metastases * Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1 * Any of the following cardiac conditions: * History of myocardial infarction, acute coronary syndromes up to 12 weeks before Cycle 1 Day 1 * Class III or IV heart failure up to 6 months before Cycle 1 Day 1 * Baseline heart rate corrected QT interval (QTc)\> 450 msec * History of ventricular arrhythmias up to 6 months before Cycle 1 Day 1 * Use of medications that prolong the QTc interval and are associated with Torsades de Pointe (TdP) * Previous cancer treatment up to 21 days before first dose * Any investigational therapy up to 28 days before Cycle 1 Day 1 * Known allergy to cyclodextrins Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.

Study Objectives The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approved for the prevention of fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. Posaconazole is available only as an oral suspension and has to be given with food. After chemotherapy, many patients are not able to tolerate food or oral medication because of severe mucositis. Patients unable to tolerate food and oral medications cannot take posaconazole. Micafungin is an antifungal medication that is given only intravenously. Micafungin is approved for the treatment of certain fungal infections and for preventing fungal infections in patients who receive bone marrow transplant. The investigators know that micafungin is safe. Micafungin has not been tested for the prevention of fungal infections in patients receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is given by vein, it can be given even in patients who cannot take food or medications by mouth after chemotherapy. In this study the investigators want to compare micafungin to posaconazole when given for the prevention of fungal infections in leukemia and myelodysplastic syndrome patients. Conditions: Acute Myelogenous Leukemia, Myelodysplastic Syndrome Intervention / Treatment: DRUG: micafungin, DRUG: posaconazole Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects of greater than or equal to 18 years of age of either sex and of any race. Disease definition: * Anticipated or documented prolonged neutropenia (ANC\<500/mm3 \[0.5x109/L\]) at baseline or likely to develop within 3 to 5 days and lasting for at least 7 days due to: * Intensive induction chemotherapy for new diagnosis of acute myelogenous leukemia, acute lymphocytic leukemia or myelodysplastic syndrome receiving standard anthracycline based chemotherapy * Re-induction of acute myelogenous or lymphocytic leukemia after primary relapse * Myelodysplastic syndromes requiring induction (myelosuppressive) chemotherapy * Female subjects of childbearing potential must have a negative serum pregnancy test as per MSKCC guidelines. * Able to swallow oral medications Exclusion Criteria: * Subjects with history of presumed or proven invasive fungal infection within 30 days of randomization. * Subjects who are taking the following: Drugs known to interact with posaconazole and that may lead to life-threatening side effects (terfenadine, cisapride, and ebastine at entry or within 24 hours before entry, or astemizole at entry or within 10 days before entry); b. Drugs known to lower the serum concentration/efficacy of posaconazole: cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, and isoniazid at entry or within 24 hours before entry; c. Subjects who are planned to receive \> 2mg flat dose of vinca alkaloids. * Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents. * Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at baseline or likely to require dialysis during the study). * Subjects having an electrocardiogram with a prolonged QTc interval by manual reading: QTc greater than 490 msec. * Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin level greater than 3 times the ULN. * Subjects who are undergoing re-induction chemotherapy and have participated in this study during their first induction chemotherapy. * Subjects who will be receiving dasatinib.