Datasets:

ravistech

/

clinical-trial-llm-v2

like 0

Follow

ravistech 6

Study Objectives The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Abiraterone acetate, DRUG: Dutasteride, DRUG: Prednisone

Inclusion Criteria: * Diagnosis of adenocarcinoma of the prostate * Castrate resistant disease * Metastatic disease * Normal organ and marrow function * Subjects with partners of childbearing potential must be willing to use adequate methods of birth control Exclusion Criteria: * Uncontrolled intercurrent illness * Uncontrolled hypertension * Active or symptomatic viral hepatitis or chronic liver disease * History of pituitary or adrenal dysfunction * Clinically significant heart disease * History of a different malignancy unless disease-free for at least 5 years * Known brain metastasis * History of gastrointestinal disorders * Prior therapy with abiraterone acetate * HIV-positive individuals on antiretroviral therapy * Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily * Atrial fibrillation or other cardiac arrhythmia requiring therapy * Thromboembolism in the last 6 months

Study Objectives Milk thistle is an herbal drug that may have some liver protection properties and may reduce inflammation in the liver. It may also have anticancer effects. However milk thistle is not approved by the Food and Drug Administration for any medical purpose in the United States. It has not been used in patients with liver cancer previously, to our knowledge, but there have been many studies of its use in patients with hepatitis and cirrhosis. Some of these studies have shown that milk thistle may help reduce elevated liver function tests. Siliphos is a derivative of milk thistle that can be absorbed better than some other types of milk thistle. The investigators would like to perform a study to identify doses of siliphos that are safe to take in advanced liver cancer and to identify positive or negative side effects this compound may have. The investigators will be using this information in future studies to see if siliphos can be used as a therapy in patients with advanced liver cancer to reduce elevated liver function tests. Conditions: Advanced Hepatocellular Carcinoma Intervention / Treatment: DRUG: Silybin

Inclusion Criteria: * Age ≥18 years * ECOG performance score of 0-3 * Expected survival of >12 weeks * Subjects with advanced HCC or locally advanced, unresectable HCC * Elevated LFTs (including at least one of the following: TBili >1.5 times the upper limit of normal; serum AST >2.5 times the upper limit of normal * HCC diagnosed/defined based on either biopsy, or by suggestive radiologic imaging according to the AASLD guidelines (arterial enhancement with venous washout) or an AFP >200 ng/ml * Subjects must have measurable disease that can be accurately measured in at least one dimension (with at least >20mm diameter in the longest dimension by conventional imaging or >10 mm by helical CT) * Elevated liver enzymes that are either due to underlying liver disease and/or tumor which is not amenable to stenting after discussion with interventional GI and/or IR * Subjects must demonstrate an ability to understand the consent process and willingness to sign a written informed consent form * Subjects must agree to use birth control pills or other active contraception during active study treatment Exclusion Criteria: * Pregnant women or women currently breastfeeding will be excluded from this study because the effects of silybin on pregnant women and/or nursing infants are not known * Subjects must have < grade 4 hepatic toxicity * Known brain metastases because of poor prognosis and as patients with brain metastases often develop neurological dysfunction that may confound evaluation of neurologic and other adverse side effects * History of allergic reactions to the study medication * Uncontrolled concurrent illness including, but not limited to: ongoing active infection (including SBP), symptomatic congestive heart failure, unstable angina, active cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements

Study Objectives The purpose of this study to assess early markers of cardiovascular disease in women with polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and chlormadinone acetate alone or associated with Spironolactone. Conditions: Polycystic Ovary Syndrome Intervention / Treatment: DRUG: oral contraceptive, DRUG: Oral contraceptive plus spironolactone, DRUG: Oral contraceptive plus metformin

Inclusion Criteria: * age between 18 and 35 years * diagnosis of PCOS by Rotterdam Consensus Exclusion Criteria: * smoking, alcoholism, drug addiction; * current pregnancy; * current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives; * current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device); * antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins; * presence of systemic diseases (DM2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia); * personal history of arterial or venous thrombosis; chronic or acute inflammatory processes; * puerperium of 12 weeks or less

Study Objectives The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor. Conditions: BRCA Gene Rearrangement Intervention / Treatment: GENETIC: BRCA 1, DRUG: Chemotherapy

Inclusion Criteria: * Metastatic gastric cancer( Adenocarcinoma) * Eastern Cooperative Oncology Group (ECOG) performance 0-2 * one more measure lesion * White blood cell count (WBC) > 3000/ul , Platelet > 75,000/ul * Normal kidney function (serum creatinine < 1.5 ULN) * Normal Liver function (Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) < 3 times of upper normal limit, if liver metastasis, AST/ALT < 5 times of upper normal limit) * life expectancy is more than 3 months * Conventional surgery that does not cause the transformation of the target lesion is allowed * The patient who voluntarily decided to participate in this study and agreed in writing Exclusion Criteria: * Her-2 positive advanced gastric cancer * Central nervous system metastases requiring treatment with symptoms * Major uncontrolled cardiovascular disease (including myocardial infarction and congestive heart failure within 6 months) * Uncontrolled infection or other serious diseases * Patients with serious medical conditions or serious illnesses * Patient who is pregnant or lactating * Adjuvant chemotherapy before 6 months (patients who have not received platinum-based chemotherapy even if they are 6 months old can register) * In the past, if the primary lesion or target lesion was treated with radiation (if the recurred lesion is outside the range of radiation therapy)

Study Objectives Preclinical studies provide strong support for the concept that fasting evokes resistance to multiple forms of stress. Fasting reduces plasma levels of growth factors and modulates intracellular nutrient sensing systems, thereby diverting energy from growth to maintenance. Accordingly, the currently available preclinical evidence suggests that short-term fasting protects normal cells against the perils of chemotherapy. In contrast, cancer cells are not protected, as a result of their self-sufficiency in growth signals. This phenomenon is termed Differential Stress Resistance (DSR). DSR reduces the severity of toxic side-effects of chemotherapy and interestingly, it simultaneously renders cancer cells more vulnerable to chemotherapeutics. Importantly, extensive preclinical evidence and preliminary clinical data indicate that a specifically designed very low calorie, low amino acid substitution diet ("Fasting Mimicking Diet, FMD") has effects on cancer therapy that are very similar to those of fasting. This study aims to evaluate the impact of the FMD on tolerance to and efficacy of neoadjuvant chemotherapy in women with stage II or III breast cancer. Conditions: Fasting Mimicking Diet, Breast Cancer, Neoadjuvant Chemotherapy, Pathological Complete Response Intervention / Treatment: OTHER: Fasting mimicking diet

Inclusion Criteria: * Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer receiving neoadjuvant AC-T * Measurable disease (breast and/or lymph nodes) * HER2 negative core biopsy Age ≥18 years * WHO performance status 0-2 * Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l * Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL * Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min * Patients must be accessible for treatment and follow-up * Written informed consent according to the local Ethics Committee requirements * Willing to fill in quality of life questionnaires * Able to read and write in Dutch Exclusion Criteria: * History of breast cancer (invasive or non-invasive) * Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. * Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias * Diabetes Mellitus * Body mass index (BMI) < 19 kg/m2 * Pregnancy or lactating * Significant food allergies which would make the subject unable to consume the food provided (ex: nuts or soy) * Any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods. * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Study Objectives The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors. Conditions: Solid Tumor Intervention / Treatment: DRUG: LY3321367, DRUG: LY3300054

Inclusion Criteria: * For Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor. * For Phase 1a and 1b, prior PD-1 or PD-L1 therapy or other immunotherapy is allowed, if the following criteria are met: * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. * Must have completely recovered or recovered to baseline prior to screening from any prior AEs occurring while receiving prior immunotherapy. * Must have provided tumor tissue sample, as follows: * For participants entering Ph1a: have submitted, if available, an archival tumor tissue sample. * For participants entering Ph1b: have submitted, a sample from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6 months of study enrollment (Ph1b). * Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Must have adequate organ function. * Have an estimated life expectancy of 12 weeks, in judgement of the investigator. Exclusion Criteria: * Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible). * Have received a live vaccine within 30 days before the first dose of study treatment. * If female, is pregnant, breastfeeding, or planning to become pregnant. * Have a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's participation. * Have moderate or severe cardiovascular disease. * Have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including active or chronic infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment. * Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, cyclosporine). \[Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted\]. * Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection. * Evidence of interstitial lung disease or noninfectious pneumonitis.

Study Objectives This is a first in human, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of AMV564. Conditions: Acute Myeloid Leukemia Intervention / Treatment: BIOLOGICAL: AMV564, COMBINATION_PRODUCT: AMV564 in combination with pembrolizumab

Inclusion Criteria: * ≥ 18 years of age at the time of signing informed consent * Diagnosis of AML according to the World Health Organization (WHO) 2008 criteria * Relapsed or refractory disease meeting the following criteria: 1. Primary refractory, ie, refractory to induction with a standard intensive anthracycline/cytarabine-based regimen or a non-intensive regimen (e.g., decitabine, azacytidine, low-dose cytarabine) for patients ineligible for an intensive anthracycline/cytarabine-based therapy 2. First untreated relapse after a first CR lasting less than 12 months or first relapse refractory to salvage therapy regardless of length of first CR; or 3. Second or later relapse. Relapse is defined as the reappearance of leukemic blasts in the peripheral blood or ≥ 5% leukemic blasts in the bone marrow after prior achievement of a CR or CRi. OR Patients with newly diagnosed therapy-related AML, AML progressed from antecedent MDS or CMML treated with hypomethylating agents, or de novo AML with MDS-related cytogenetic abnormalities (per 2008 WHO criteria) and who are not candidates for (or decline) intensive remission induction therapy * No more than 3 prior induction/salvage regimens to treat active disease, and no more than 1 prior stem cell transplant. Any number of continuous cycles of therapy with an individual hypomethylating agent count as one induction or salvage regimen. * Blasts at least 5% in bone marrow * Peripheral white blood cell (WBC) count: no upper limit at Screening, but must be < 10 x 109/L on Day 1 prior to treatment; patients with excessive blasts may be treated with hydroxyurea to bring counts down. * Chemistry laboratory parameters within the following range: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x the upper limit of normal (ULN) 2. Total bilirubin ≤ 1.5x the ULN; patients with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits. 3. Creatinine clearance > 50 mL/min (measured or calculated by Cockcroft-Gault method) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with ECOG score of 2 may be included, after discussion with the Sponsor Medical Monitor, if score is influenced by symptoms attributable to underlying AML disease. * Willing to complete all scheduled visits and assessments at the institution administering therapy * Able to read, understand and provide written informed consent Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study. * History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥ 3 drug-related CNS toxicity * Prior allogeneic transplant (dose escalation only) * Prior solid organ transplantation * Treatment with anti-thymocyte globulin (ATG) within 14 days prior to start date * Treatment with any local or systemic antineoplastic therapy or radiation within 14 days prior to the initiation of AMV564 administration (hydroxyurea is exempted if used to reduce total WBC counts) * Clinically significant cardiac disease, * Pulmonary, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements * Evidence of active, uncontrolled, viral, bacterial, or systemic fungal infection. Prophylactic therapy according to institutional protocols is acceptable. * Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) * Active hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded. * Second primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3-year remission include: non-melanoma skin cancer; cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Papanicolaou (PAP) smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ. * Major trauma or major surgery within 28 days prior to the initiation of AMV564 treatment * Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or confound the results of the study. * Ability to become pregnant. However, female patients who have a negative serum or urine pregnancy test before enrollment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom; intrauterine device and condom; diaphragm with spermicidal gel and condom) during the trial and for 90 days afterward (90 days after the end of AMV564 treatment) are considered eligible. * Male patients with partners of childbearing potential. * Pregnant or breastfeeding women * Is a participant or plans to participate in another interventional clinical study, while taking part in this protocol. Participation in an observational study is acceptable.

Study Objectives The purpose of this study is to determine if orally-administered recombinant human lactoferrin is effective in the treatment of advanced renal cell carcinoma (RCC) in patients who have failed at least one prior systemic therapy for RCC. Conditions: Carcinoma, Renal Cell Intervention / Treatment: DRUG: Recombinant Human Lactoferrin

Inclusion Criteria: * Age ≥18 years * Histologically confirmed, advanced or metastatic RCC with predominantly clear cell histology that is unresectable or medically inoperable. * Experienced and failed at least one regimen of systemic therapy for RCC with CT documentation of disease progression. * A previous CT (4 weeks or more prior to the Screening CT) showing progression of the target tumor(s) compared to a prior CT no more than 9 months previously * At least one target tumor lesion is measurable at Screening with CT scan, according to RECIST, and not previously irradiated * Karnofsky performance status of ≥70 (ECOG <2) * Able to understand and sign an informed consent Exclusion Criteria: * Significant sarcomatoid, spindle cell, or nuclear grade 4 histology * Significant non-clear cell RCC (for example, papillary, chromophobe, collecting duct, granular, or unclassified RCC) * Total bilirubin >1.5 mg/dL * Serum creatinine >2.0 mg/dL * Hemoglobin <10.0 g/dL * Absolute neutrophil count <2000/mm3 * Lymphocytes <800/mm3 * Platelet count <100,000/mm3 * AST (SGOT) or ALT (SGPT) ≥2.5 x institutional upper limit of normal * Serum calcium >11.5 mg/dl * International Normalized Ratio of Prothrombin Time (INR) >1.2 * FEV1 <60% predicted or FVC <60% predicted by spirometry (both are to be measured) * Existing or history of brain metastases * History of allergic reactions to compounds of similar chemical or biologic composition to the Study Agent rhLF * Active ischemic heart disease, symptomatic congestive heart failure * Serious active infection * Psychiatric illness/social situations that would limit compliance with study requirements * Autoimmune diseases (e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis) * Other malignancies, except non-melanoma skin cancer, within 5 years of study entry * Radiotherapy within 4 weeks prior to study treatment start * Corticosteroid therapy within 4 weeks prior to treatment start, with the exception of inhaled or topical steroids * Chemotherapy/Immunotherapy (e.g., IL-2, INFα, tumor vaccine) within 4 weeks prior to study treatment start * Known HIV positive * Receipt of any investigational medication within 30 days prior to participation in the study * Pregnant or lactating patients, or fertile female patients with a positive pregnancy test (serum β-human chorionic gonadotropin \[β-HCG\] at Screening and on Day 1 prior to the first dose), or fertile female patients unwilling to use adequate contraception prior to study entry, during treatment and 30 days after completion of treatment * Sexually active male patients unwilling to practice contraception while participating on this study and up to 30 days after completion of treatment * Unable to take liquid medication by mouth or feeding tube

Study Objectives The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer. Conditions: Advanced Cancer Intervention / Treatment: DRUG: ANX-514, DRUG: docetaxel

Inclusion Criteria: * Over 18 years old. * Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment. * ECOG performance status of 0-2 and Karnofsky Score of 100-70. Exclusion Criteria: * Patients who have more effective therapy available than single agent docetaxel for the malignancy. * Pregnancy or lactation. * Intolerance to any antineoplastic agents belonging to the taxoid family. * Hypersensitivity to drugs formulated with polysorbate 80. * Active infection. * Prior anticancer therapy within 30 days prior to the first day of study treatment. * Participation in another experimental drug study within 30 days prior to the first day of study treatment.

Study Objectives The goal of this clinical trial is to learn the comparative pharmacokinetic parameters between the test product and the Reference listed drug in healthy female volunteers The main question\[s\] it aims to answer are: * To assess the sequential dose exposure safety and tolerability of KSHN001034 injection in healthy female subjects after single ascending doses from 25 mg to 500 mg and multiple doses of maximum tolerable dose from single ascending dose * To assess dose showing comparative bioavailability of KSHN001034 injection in comparison with Faslodex®. Conditions: Metastatic Breast Cancer Intervention / Treatment: DRUG: Fulvestrant injection

Inclusion Criteria: * The subject is healthy female adult of population aged between 40 to 60 years old (inclusive) at screening. * The subject has a body weight not less than 50 Kg and according to the BMI range (18.5 - 30 Kg/m2)6 (inclusive) at screening. * The subject is fully vaccinated for COVID-19 at least two weeks ago, as checked at screening. -. The subject is physically and mentally healthy as judged by means of medical and standard laboratory examinations at screening. * The findings of the subject are within the range of clinical acceptability in medical history, and physical examination, and laboratory results "other than RBC indices (MCH, MCV and MCHC), and hemoglobin, " within "normal ranges" for the laboratory tests performed or abnormalities considered insignificant and justified by the principal/clinical sub- investigator at screening. * The subject results are within normal range or ± 5% of medical lab reference range for all RBC indices (MCH, MCV and MCHC) and hemoglobin, at screening -. The subject's platelets count is within medical lab reference range at screening. * The subject has a normal ECG (12 leads), including normal QTc (below 440 msec), at screening * The subject's chest X-ray, performed within 6 months before screening (if available) or at screening, is normal or considered clinically acceptable with no evidence of ongoing or past serious infections, as per the investigator judgment at screening. * The subject vital signs in sitting position are within the following ranges at screening, and on admission day (before admission): Blood Pressure: Systolic: (90 - 140) mmHg Diastolic: (60-90) mmHg Body Temperature: (36.1 - 37.2) ºC Pulse rate: 60 to 100 beat per minute. Respiratory rate: 12-18 bpm. * Kidney function tests (Creatinine, Potassium and Sodium) are within the medical lab reference range and kidney function tests (Blood Urea Nitrogen, and uric acid) are considered clinically acceptable as per the investigator judgment at screening. If creatinine is below the lower normal limit while the other parameters are normal, it will be considered as clinically not significant unless otherwise judged by the investigator. * Liver function tests (AST, ALT, GGT, and bilirubin (total, direct, and indirect)) results are within the medical lab reference ranges and liver function tests (Alkaline phosphatase, total protein, and albumin) are considered clinically acceptable as per PI / SI judgment at screening. Exclusion Criteria: * The subject has an evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements, as determined by the principal investigator/clinical Sub-investigator at screening or on admission day (before admission). * The subject has a known history or presence of any clinically significant abnormality / pathology / disease in any of the body systems, as checked at screening or on admission day (before admission). * The subject has a clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, active inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), short bowel syndrome, upper gastrointestinal surgery including gastric resection, or other conditions known to interfere with the metabolism or excretion of the drug as determined by the principal investigator/clinical sub-investigator at screening or on admission day (before admission). * The subject has a history of allergy or major allergic reactions or known allergy/ hypersensitivity to the drug under investigation (Fulvestrant), or to any of the excipients (ethanol, benzyl alcohol, benzyl benzoate, castor oil refined), as checked at screening * The subject has a history of hypersensitivity to heparin as checked at screening. * The subject has a history of vaginal bleeding or discharge, bleeding diatheses, thrombocytopenia or taking anticoagulant treatment as checked at screening. * The subject has symptoms suggestive of COVID-19 as judged by the principal investigator/clinical sub-investigator at screening or admission day (before admission). The subject is pregnant or nursing (lactating) women, where pregnancy is defined as the state of the female after conception and until the termination of gestation, confirmed by a positive serum pregnancy test at screening or on admission day (before admission). * The subject has consumed or does not agree to abstain from consuming any beverages or food containing alcohol from screening until donating the last PK sample of the study cohort, as checked at screening or on admission day (before admission). * The subject does not agree to abstain from consuming any beverages or food containing methylxanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate, ...etc) for at least 24 hours prior to each dosing and for 24 hrs after each dosing, as checked at screening or on admission day (before admission). * The subject has taken any prescribed drugs within four weeks preceding first study drug administration or doesn't agree on not taking them until donating last PK sample of the study cohort, as checked at screening or on admission day (before admission).

Study Objectives This study evaluates the women cervical samples through molecular tests in order to: 1. Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer Hospital to evaluate their performance; Conditions: Cervical Cancer Squamous Cell, Human Papilloma Virus Infection, Human Papilloma Virus-Related Carcinoma, Prevention Intervention / Treatment:

Inclusion Criteria: * Any women who come to do the Papanicolaou test at the Barretos Cancer Hospital and in the mobile units on the remote Brazilian areas. Exclusion Criteria: * not applicable.

Study Objectives The main objective of the trial is to document the safety and antivascular effect of escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by advanced or metastatic solid tumors not amenable of standard therapies. Safety will be established by clinical and laboratory assessment according to NCI-CTCAE criteria (version 4.02). Conditions: Solid Tumors Intervention / Treatment: DRUG: NGR-hTNF

Inclusion Criteria: * Patients ≥18 years with selected metastatic solid tumours recognized to be highly vascularised and not amenable to any clinical improvement by current standard treatments * Colorectal cancer (CRC) patients previously resistant to standard systemic regimens (including biologic agents) * Gastric cancer (GC) patients treated with no more than two standard systemic regimens for metastatic disease * Hepatocellular carcinoma (HCC) patients previously resistant to standard systemic regimens * Pancreatic carcinoma (PC) patients treated with no more than one standard systemic regimen for metastatic disease * Non small cell lung carcinoma (NSCLC) patients treated with no more than two standard systemic regimens (including biologic agents) for metastatic disease * Neuroendocrine (NE) tumours refractory to somatostatin analogue treatment * Other rare tumours including malignant pleural mesothelioma (MPM), soft-tissue sarcoma (STS), and renal cell carcinoma (RCC), resistant/refractory to current standard treatments * Life expectancy more than 3 months * ECOG Performance status 0-1 * Adequate baseline bone marrow, hepatic and renal function, defined as follows: * Neutrophils >1.5 x 10\^9/L and platelets > 100 x 10\^9/L * Bilirubin <1.5 x ULN * AST and/or ALT <2.5 x ULN in absence of liver metastasis * AST and/or ALT <5 x ULN in presence of liver metastasis * Serum creatinine <1.5 x ULN * Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min * Patients may have had prior therapy providing the following conditions are met before treatment start: * Chemotherapy, radiation therapy, hormonal therapy, or immunotherapy: wash-out period of 28 days * Surgery: wash-out period of 14 days * Patients must give written informed consent to participate in the study. Exclusion Criteria: * Concurrent anticancer therapy * Patients must not receive any other investigational agents while on study * Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication * Uncontrolled hypertension * Prolonged QTc interval (congenital or acquired) > 450 ms * Patient with significant peripheral vascular disease * History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy), or history of stroke * Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol * Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol * Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.

Study Objectives RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer. Conditions: Kidney Cancer Intervention / Treatment: DRUG: bortezomib

Inclusion Criteria: * Histologically confirmed pure non-clear cell renal cell carcinoma (RCC) * Distant metastatic disease (Tx, Nx, M1) * Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein * Measurable disease on imaging scan (≥ 1 cm) * Brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy. * Life expectancy ≥ 3 months * Karnofsky performance status ≥ 60% * Negative pregnancy test * Fertile patients must use an acceptable method of contraception * No other major illnesses likely to limit survival * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1, 000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusion allowed) * Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL * ALT or AST ≤ 2.5 times upper limit of normal * At least 4 weeks since prior radiotherapy and recovered * More than 30 days since any other prior investigational drugs Exclusion Criteria: * active CNS metastases * pregnant or nursing * myocardial infarction within the past 6 months * New York Heart Association class III or IV heart failure * uncontrolled angina * severe uncontrolled ventricular arrhythmias * electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Peripheral neuropathy ≤ grade 1 * hypersensitivity to bortezomib, boron, or mannitol * history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin * serious medical or psychiatric illness that would preclude study participation * prior cytotoxic chemotherapy for this cancer * other concurrent investigational therapy * concurrent chemotherapy, immunotherapy, or hormonal therapy

Study Objectives Primary aldosteronism (PA) is the excessive endogenous production of the mineralocorticoid aldosterone. Although various rare forms of PA exist, the vast majority of cases are accounted by either an aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia. During the last decades the prevalence of PA has risen, predominantly due to better awareness of disease. Several studies estimated a prevalence of PA up to 17% in an unselected population of hypertensive patients. However, in a population with resistant hypertension the reported prevalence is even higher: 17-23%. This emphasizes the clinical impact of PA on morbidity and mortality due to high blood pressure. Since both hypertension and aldosteronism are independent risk factors for cardiovascular morbidity, the aim of treatment is curation or reduction of both. After an adrenalectomy for APA normalization of biochemical abnormalities is achieved in almost all cases. Nevertheless, curation of hypertension (systolic blood pressure \<140 and diastolic blood pressure \<90 mmHg) without the need of antihypertensive medication is accomplished in only 35-45% of the cases. In 2008 the Aldosteronoma Resolution Score (ARS) was developed. This score predicts the likelihood of complete resolution of the hypertension in patients with an aldosteronoma and has been validated by other investigator groups. Reduction of hypertension is also an important clinical outcome and is reported in 90-98% of the patients after surgery. In most studies reduction is defined as a certain decrease in blood pressure or antihypertensive medication. However, there is no consensus on the precise definition of reduction in these patients, which leads to incomparable results. The aim of the proposed study is to determine the proportion of patients with clinically relevant reduction of hypertension after adrenalectomy in a large cohort. Furthermore, the investigators aim to determine the characteristics predicting this clinically relevant reduction. Additionally, the investigators evaluate the predictive value of the Aldosteronoma Resolution Score for clinically relevant reduction and aim to develop a scoring system to help clinicians predict the likelihood of reduction of hypertension after adrenalectomy so it can be used for patient counseling. Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism, Primary Aldosteronism Due to Conn Adenoma Intervention / Treatment: PROCEDURE: Unilateral adrenalectomy

Inclusion Criteria: * All patients who underwent unilateral adrenalectomy between 2010 and 2016 for APA. * Patients with biochemical evidence of primary aldosteronism who underwent adrenalectomy on account of an aldosterone-producing adenoma(APA), proven by Computerized Tomography(CT) or Magnetic Resonance Imaging(MRI) or Adrenal Venous Sampling(AVS). Exclusion Criteria: * Age <18 years. * Missing or incomplete data about preoperative blood pressure and number of antihypertensive drugs. * Missing or incomplete follow-up data about postoperative blood pressure and number of antihypertensive drugs. We aim enter the blood pressure and number of antihypertensive drugs closest to 6 months after adrenalectomy.

Study Objectives RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases. Conditions: Cognitive/Functional Effects, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: RADIATION: intensity-modulated radiation therapy

INCLUSION CRITERIA: * Histologically or cytologically confirmed non-hematopoietic malignancy within the past 5 years * If histologic proof of malignancy is from > 5 years ago, then a more recent pathological confirmation is required (e.g., from systemic metastatic or brain metastasis) * Patients with metastasis of unknown primary tumor are permitted * Measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast-enhanced MRI obtained within the past 30 days * Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical resection * These treatment options are allowed only at relapse * Patients who have brain metastases at initial presentation allowed and do not need to demonstrate 3 months of stable scans * At least 1 week since open biopsy * Karnofsky performance status 70-100% * Fertile patients must use effective contraception * Negative pregnancy test 2 weeks or less prior to study entry * Patients must be English proficient, with patients who speak English as a second language eligible EXCLUSION CRITERIA: * Small cell lung cancer or germ cell malignancy * Leptomeningeal metastases * Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of extracranial metastases * Radiologic evidence of hydrocephalus * Serum creatinine > 1.4 mg/dL within 30 days prior to study entry * Pregnant or nursing * Contraindication to MRI imaging such as implanted metal devices or foreign bodies or severe claustrophobia * Severe, active co-morbidity including any of the following: * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Transmural myocardial infarction within the past 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy * Uncontrolled, clinically significant cardiac arrhythmias * Prior radiotherapy to the brain * Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7 days

Study Objectives This research study involves the use of two investigational drugs: sorafenib and bortezomib. Sorafenib is designed to stop the growth of cells caused by changes associated with cancer. Bortezomib is designed to stop cancer cells from getting rid of waste products. This causes the cells to build up toxic levels of waste that leads to cell death. In the laboratory, the combination of sorafenib and bortezomib has been shown to fight cancer cells better than either drug alone. We are looking to determine if the combination of sorafenib and bortezomib is a safe treatment for patients with advanced melanoma. The effectiveness of this combination will also be assessed. Conditions: Melanoma Intervention / Treatment: DRUG: bortezomib, DRUG: sorafenib

Inclusion Criteria: * Histological or cytological confirmation of malignant melanoma that is metastatic or unresectable * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 10mm or greater with spiral CT scan * Patients may have received up to 4 prior treatments for their disease including immunotherapies such as high-dose interleukin 2 and antibodies directed against the human cytotoxic T-lymphocyte antigen 4 * 18 years of age or older * Life expectancy of greater than three months * ECOG Performance status of 0 or 1 * Adequate organ and marrow function as outlined in the protocol * Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment * INT < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment wih an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: * Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events dur to agents administered more than 4 weeks earlier * Participants may not be receiving any other study agents * Known, active CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any unstable or untreated brain metastasis, or history of stroke within the past 12 months * Prior therapy with bortezomib, sorafenib, or other proteasome inhibitor * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib and bortezomib * Participants receiving any medications or substances that are inducers of CYP3A4 * Known cardiac disease including congestive heart failure > class II NHYA, unstable angina or new onset angina, myocardial infarction within the past 6 months, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Uncontrolled intercurrent illness * Pregnant women * Individuals with a history of a different malignancy are ineligible except for the circumstances outlined in the protocol * HIV-positive individuals on combination antiretroviral therapy * Uncontrolled hypertension despite optimal medical management * Thrombolic or embolic events * Pulmonary hemorrhage/bleeding event CTCAE Grade 2 or greater within 4 weeks of first dose of study drug * Any other hemorrhage/bleeding event CTCAE Grade 3 or greater within 4 weeks of first dose of study drug * Serious non-healing wound, ulcer or bone fracture * Evidence or history of bleeding diathesis or coagulopathy * Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug * Any condition that impairs patient's ability to swallow whole pills * Any malabsorption problem * Known hypersensitivity to boron or mannitol * Grade 2 or greater peripheral neuropathy within 14 days before enrollment

Study Objectives This is a multicenter, worldwide, open-label study of MK-8353 in combination with selumetinib in participants with histologically or cytologically confirmed diagnosis of advanced solid tumor. This study will evaluate the safety, tolerability, and exploratory efficacy of MK-8353 in combination with selumetinib. Conditions: Solid Tumors Intervention / Treatment: DRUG: MK-8353, DRUG: Selumetinib

Inclusion Criteria: * Have a histologically- or cytologically-documented, locally-advanced or metastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit. * Provide an archival or newly obtained tumor tissue sample and blood samples for assessment of proto-oncogene rat sarcoma virus (RAS)/rapidly accelerated fibrosarcoma (RAF) mutation and for biomarker analysis. * Have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) on imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) as assessed by the investigator/local radiology review. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. (Obtain within 7 days prior to first dose of study treatment.) * Have the ability to swallow and retain oral medication. * Demonstrate adequate organ function. * Male participants must agree to use an acceptable contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period. * Female participants must not be pregnant, not breastfeeding, and either not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the study's contraceptive guidance during the treatment period and for at least 120 days, after the last dose of study intervention. Exclusion Criteria: * Have had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study treatment, or has not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related AEs). * Have clinically active central nervous system metastases and/or carcinomatous meningitis. * Have an active infection requiring therapy. * Have known human immunodeficiency virus (HIV) and/or Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) or Hepatitis C Antibody or ribonucleic acid (RNA). * Have clinically significant cardiovascular disease as defined by study criteria. * Have a history of thromboembolic or cerebrovascular events within 6 months prior to treatment start, including transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), deep vein thrombosis, or pulmonary embolism. * Have neuromuscular disorders associated with an elevated creatine kinase (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). * Have one or more study-defined ophthalmological findings/conditions. * Have a known history of Gilbert's Syndrome. * Have a history or current evidence of a gastrointestinal (GI) condition (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications. * Have a known psychiatric or substance abuse disorder, or any other cognitive disorder that would interfere with the participant's ability to cooperate with the requirements of the study. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study treatment. * Received prior therapy with a mitogen activated protein kinase (MEK) inhibitor (e.g., cobimetinib, trametinib), or an extracellular signal-regulated kinase (ERK) inhibitor (e.g., MK-8353, GCD-0994, ulixertinib), or a proto-oncogene BRAF inhibitor (e.g., dabrafenib, vemurafenib). * Is currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days of administration of selumetinib. * Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents and/or excipients used in the study. * A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment

Study Objectives This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices. Conditions: Depressive Symptoms, Anxiety, Cancer Intervention / Treatment: DRUG: psilocybin

Inclusion criteria Volunteers must: * Have given written informed consent * Have a high school level of education * Be 21 to 80 years old * Has or has had a cancer diagnosis that is potentially life-threatening. Patients with an active cancer (e.g. stage III or IV with a poor prognosis) or disease progression or recurrence are eligible. Patients who do not have an active cancer or disease progression or disease recurrence are only eligible if at least 1 year has elapsed since their diagnosis. * Have an ECOG performance status of 0, 1, or 2. * Have a DSM-IV psychiatric diagnosis, as determined by the SCID, of one or more of the following Axis I psychiatric disorders that is either precipitated by or exacerbated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Post traumatic Stress Disorder; Major Depressive Disorder (mild or moderate severity); Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnosis will be determined by BPRU staff. * Patients receiving chemotherapy, hormonal therapy, radiation therapy, biologic therapies may participate while receiving those therapies. Continuing hormonal therapy, chemotherapy, or radiation treatment is acceptable if the patient is tolerating the therapy or treatment in a sufficient fashion to allow administration of oral psilocybin. * Agree that for one week preceding each psilocybin session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals. * Agree not to use nicotine for at least 2 hours before psilocybin administration, and not again until questionnaires have been completed approximately 7 hours after psilocybin administration. * Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of psilocybin session days. If the patient does not routinely consume caffeinated beverages, he or she must agree not to do so on psilocybin session days. * Agree not to take any PRN medications on the mornings of psilocybin sessions, with the exception of daily opioid pain medication. Non-routine PRN medications for treating breakthrough pain that were taken in the 24 hours before the psilocybin session may result in rescheduling the treatment session, with the decision at the discretion of the investigators. * Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each psilocybin administration. As described elsewhere, exceptions include daily use of caffeine, nicotine, and opioid pain medication. Exclusion criteria General Medical Exclusion Criteria * Cancer with known CNS involvement, or other major CNS disease. In addition to diagnostic results provided by the referring physician, patients will undergo a neurological exam performed by our BPRU internist. Any patient with evidence of a focal deficit will be excluded. * Hepatic dysfunction as indicated by the following values: * GGT > 3 x ULN (upper limit of norm) * AST > 3 x ULN * ALT > 3 x ULN * Tot Bili > 3.0 mg/dl * Known paraneoplastic syndrome or "ectopic" hormone production by the primary tumor such as the patient could have or be at risk for hypercalcemia, Cushing's syndrome, hypoglycemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome * Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrillation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication) * Blood pressure exceeding screening criteria described below * Epilepsy with history of seizures * Renal disease (creatinine clearance < 40 ml/min using the Cockcroft and Gault equation) * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia * Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control * Currently taking on a regular (e.g., daily) basis: investigational agents, psychoactive prescription medications (e.g., benzodiazepines), medications having a primary pharmacological effect on serotonin neurons (e.g., ondansetron), or medications that are MAO inhibitors. Long-acting opioid pain medications (e.g. oxycodone sustained release, morphine sustained release -- which are usually taken at 12 hour intervals) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration. * For individuals who have intermittent or PRN use of investigational agents, psychoactive prescription medications, medications having a primary pharmacological effect on serotonin neurons, or medications that are MAO inhibitors, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose. * In addition to the foregoing, patients will be excluded if they are currently using any the following of potent metabolic inducers or inhibitors: Inducers - Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, Phenobarbital), Nevirapine, Efavirenz, Taxol, Dexamethasone), St Johns Wort; Inhibitors - all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin. * In addition to the foregoing, patients will be excluded if it is a medical requirement that they receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl. Psychiatric Exclusion Criteria * Individuals with severity of depression or anxiety symptoms warranting immediate treatment with antidepressant or daily anxiolytic medication (e.g., due to suicidal ideation). We will interview patients to determine if referral (e.g., to Community Psychiatry) is necessary. For all individuals who are consented and screened, we will notify the referring physician as to: 1) whether the individual enrolled in the study or not, and 2) if disqualified, why the individual was disqualified. If disqualification was based on severe depression or anxiety (e.g., suicidal ideation), this will be included in the information conveyed to the referring physician. Permission for this contact will be obtained from the participant. * Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder * Current or past history within the last 5 year of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine). * Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder. * Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin. Cardiovascular screening: There will be at least four blood pressure assessment occasions over at least two separate days. Within a day, assessment occasions will be separated by at least 15 minutes. Each assessment occasion will involve two or more blood pressure readings. To qualify for the study, the mean blood pressure (mm Hg) of the four or more assessment occasions will not exceed 140 systolic and 90 diastolic. Blood pressure will be taken while subjects are at rest and have been seated or supine for at least 5 minutes. As recommended by the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, these assessments will involve the average of 2 or more readings separated by two minutes. If the first 2 readings differ by more than 5 mm Hg, additional readings will be obtained and averaged. On one or more of the blood pressure measurement occasions, the volunteer will be acclimated to the automated blood pressure monitoring equipment by repeatedly taking blood pressure (at least 3 readings) with the device. Because it has been our experience that time-to-time blood pressure readings with the automated equipment can be variable due to measurement artifact, any reading that initially exceeds our threshold value will be reassessed twice within 4 minutes to assure accuracy.

Study Objectives This study is examining a chemotherapy regimen and immune suppressive medications in the setting of an allogeneic stem cell transplant. A pilot clinical trial to characterize the incidence, prevalence and function of myeloid-derived suppressor cells (MDSCs) and immune checkpoint regulators (V-domain Ig Suppressor of T-cell Activation \[VISTA\], cytotoxic T-lymphocyte- associated protein 4 \[CTLA-4\], programmed death-ligand 1 \[PD-L1\]) during early immune recovery following an allogeneic stem cell transplant. The site will use a myeloablative regimen of fludarabine with busulfan, adopted from CALGB 100801, to define clinical endpoints, including engraftment, 100 day survival and one year survival (Objective #1). The site will characterize the incidence, prevalence and function of MDSCs and immune checkpoint regulators in patients' blood and bone marrow following transplantation (Objective #2). The site will correlate these laboratory results with clinical outcomes and the incidence of graft-versus-host disease (GVHD). As an exploratory aim, in those patients experiencing GVHD and requiring treatment, the site will define the MDSCs frequency and checkpoint regulator expression and correlate these results with the patient's response to GVHD therapy. Conditions: Leukemia, Lymphoid, Leukemia, Myeloid, Myelodysplastic Syndromes, Myelofibrosis, Lymphoma, Malignant, Multiple Myeloma, Waldenstrom Macroglobulinemia Intervention / Treatment: DRUG: Fludarabine, DRUG: Busulfan, BIOLOGICAL: Rabbit ATG, DRUG: Methotrexate

Inclusion Criteria: * Age less than or equal to 75 years* The patient must be approved for transplant by the treating transplant physician. This includes completion of their pretransplant workup, as directed by standard Dartmouth-Hitchcock Medical Center (DHMC) Standard Operating Procedures (SOPs). DHMC SOP for Pretransplant Evaluation of allogeneic recipient.* The patient must have a disease, listed below, with treatment responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include: 1. Acute leukemia AML (Acute Myeloid Leukemia), ALL (Acute Lymphoid Leukemia) 2. Chronic leukemia CML (Chronic Myeloid Leukemia), CLL (Chronic Lymphoid Leukemia) 3. Myelodysplasia 4. Myelofibrosis 5. Lymphoma NHL (Non-Hodgkin's Lymphoma) and Hodgkin's disease 6. Plasma cell disorder, including myeloma, Waldenstrom's Macroglobulinemia* Donor availability- the patient must have an identified donor 1. Sibling Availability of a 6 out of 6 identical donor 2. Unrelated donor: Availability of a 6 out of 6 unrelated donor* No human immunodeficiency virus (HIV) infection or active hepatitis B or C* Easter Cooperative Oncology Group (ECOG) performance status 0, 1, or 2* Diffusing capacity of the lungs for carbon monoxide DLCO more than or equal to 40 percent predicted* Left ventricular ejection fraction more than or equal to 35 percent* Serum bilirubin less than 2x upper limit of normal transaminases less than 3x normal at the time of transplant* No active or uncontrollable infection* In female, a negative pregnancy test if experiencing menstrual periods* No major organ dysfunction precluding transplantation* No evidence of an active malignancy that would limit the patient's survival to less than 2 years. If there is any question, the principal investigator can make a decision. Exclusion Criteria: * Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible.* Major anticipated illness or organ failure incompatible with survival from bone marrow transplant.* History of refractory systemic infection Donor eligibility * Human leukocyte antigen (HLA) 6 out of 6 matched related or unrelated donor.* The donor must be healthy and must be willing to serve as a donor, based on standard guidelines* The donor must have no significant comorbidities that would put the donor at marked increased risk* There is no age restriction for the donor* Informed consent must be signed by donor, if sibling donor, or by third party if unrelated donor. Donor Exclusion Criteria* The National Marrow Donor Program (NMDP) guidelines for exclusion criteria will be used. In addition, the following donors are NOT eligible:* Syngeneic donor* Pregnant or lactating donor* Human immunodeficiency virus (HIV) or active HepB or C in the donor* Donor unfit to receive Granulocyte-colony stimulating factor (GCSF) and undergo apheresis* A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible

Study Objectives Cancer survivorship has become an important aspect of oncology research due to the risk of physical and psychosocial complications. These latter concerns 50 % of patients. So, the aim of this research is to measure frequency and intensity of one of these issues: the fear of cancer recurrence (FCR) in the lymphoma survivorship beginning, at M0. Conditions: Lymphoma Intervention / Treatment: OTHER: Questionnaires/Scales, OTHER: Human blood sample

Inclusion Criteria: * Complete response of lymphoma (Cheson criteria 2007) after initial treatment * Malin lymphoma (Hodgkin or not) treated with anthracyclines for at least 6 cycles : Adriamycin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) or BEACOPP, Cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone (CHOP) et Rituximab (R-CHOP), miniCHOP et RminiCHOP, RACVBP having received or not an intensification with autologous hematopoietic stem cell transplantation in first-line * Registered the consent to be included in this study Exclusion Criteria: * Person under judicial protection

Study Objectives This phase I trial is studying the side effects and best dose of GDC-0449 in treating young patients with medulloblastoma that is recurrent or did not respond to previous treatment. GDC-0449 may be effective in treating young patients with medulloblastoma. Conditions: Recurrent Childhood Medulloblastoma Intervention / Treatment: DRUG: vismodegib, OTHER: laboratory biomarker analysis, OTHER: pharmacological study

Inclusion Criteria: * Histologically confirmed medulloblastoma, including posterior fossa primitive neuroectodermal tumor (PNET) * Recurrent, progressive, or refractory to standard therapy * No known curative therapy exists * Neurological deficits allowed provided they are stable for ≥ 1 week prior to study entry * No atypical teratoid/rhabdoid tumor or supratentorial PNET * Karnofsky performance status (PS) 60-100% (for patients > 16 years of age) OR Lansky PS 60-100% (for patients ≤ 16 years of age) * ANC ≥ 1,000/μL\* * Platelet count ≥ 100,000/μL (transfusion independent)\* * Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed)\* * Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age as follows: * ≤ 0.8 mg/dL (for patients ≤ 5 years of age) * ≤ 1.0 mg/dL (for patients 6 to 10 years of age) * ≤ 1.2 mg/dL (for patients 11 to 15 years of age) * ≤ 1.5 mg/dL (for patients > 15 years of age) * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age * ALT/AST ≤ 2.5 times ULN for age * Serum albumin ≥ 2.5 g/dL * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use 2 effective methods of contraception during and for 12 months following study treatment * Fertile male patients must use effective barrier contraception during and for 12 months following study treatment * Body surface area > 0.67 m\^2 and ≤ 2.5 m\^2 * Able to swallow capsules * No malabsorption syndrome or other condition that would interfere with enteral absorption * No history of congestive heart failure * No history of ventricular arrhythmia requiring medication * No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, or hypokalemia, defined as less than the lower limit of normal despite adequate electrolyte supplementation * No clinically important history of liver disease, including viral hepatitis or cirrhosis * No concurrent clinically significant unrelated systemic illness (e.g., serious infection) or significant cardiac, pulmonary, hepatic, or other organ dysfunction that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results * NOTE: \* In the absence of bone marrow involvement * Recovered from prior treatment-related toxicity * At least 3 months since prior craniospinal radiotherapy (at doses ≥ 23 Gy) * At least 8 weeks since prior local radiotherapy to primary tumor * At least 2 weeks since prior focal radiotherapy to symptomatic metastatic sites * More than 4 weeks since prior myelosuppressive chemotherapy or immunotherapy (6 weeks for nitrosoureas) * More than 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or erythropoietin) * No other concurrent anticancer or investigational drug therapy * Concurrent dexamethasone allowed provided dosage is stable or decreasing for ≥ 1 week prior to study entry

Study Objectives The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumors by decreasing the blood supply to the tumors. Conditions: Biliary Tract Cancer, Gallbladder Adenocarcinoma Intervention / Treatment: DRUG: Bevacizumab, DRUG: Gemcitabine, DRUG: Oxaliplatin

Inclusion Criteria: * Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma. Patients must have at least one measurable lesion outside prior radiation field. * Zero to one prior chemotherapy for biliary tract or gallbladder cancer * Age > 18 years * ECOG performance status 0-2 * Life expectancy > 12 weeks * Adequate organ and bone marrow function Exclusion Criteria: * Chemotherapy within past 3 weeks of initiation of therapy * Pregnant or lactating women * Clinically apparent central nervous system metastases or carcinomatous meningitis * Biliary obstruction with inadequate drainage and total bilirubin > 2.5 mg/dL * Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Uncontrolled serious medical or psychiatric illness * Pre-existing peripheral neuropathy of grade 2 or greater severity according to the Common Terminology Criteria of the NCI (version 3.0) * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study * Blood pressure of > 150/100 mmHg * Unstable angina * NYHA Grade II or greater congestive heart failure * History of myocardial infarction or stroke within 6 months * Clinically significant peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy, or significant traumatic injury with 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 * Serious, non-healing wound, ulcer, or bone fracture

Study Objectives The purpose of this study is to determine the effect that oxygen has when administered to patients complaining of shortness of breath, where the underlying cause of this symptom is advanced cancer. The study tests the hypothesis that oxygen improves shortness of breath more than air in this population. Both oxygen and air will be administered to patients in random order and in a blinded fashion, with patients asked to rate their shortness of breath before and after each gas. Finally patients will be asked which gas they prefer. Conditions: Cancer Intervention / Treatment: PROCEDURE: Oxygen and air administration

Inclusion Criteria: * Patients who have dyspnoea mainly due to advanced cancer. Patients with a history of COAD will be eligible for participation in this study as long as the main mechanism of current dyspnoea is related to tumor. * intensity of dyspnoea of at least 3 on a 0-10 visual analogue scale at the time of treatment. * Regular Bronchodilators and corticosteroids and other adjuvant medications for dyspnoea will be allowed to continue during the study. Inhaled bronchodilator steriods may not be used during the study period. * Patients may be receiving regular oral or parenteral opioids and opioid dose must be stable for 24 hours. * Patients must have normal cognitive status defined as normal state of arousal and absence of obvious clinical findings of confusion, memory or concentration deficit according to Blessed Orientation Memory \& Concentration mental status examination (score<10). * Patients must be 18 years of age or older. * Patients must have no contraindications to oxygen. * Patients must sign written informed consent. Exclusion Criteria: * Patients who have evidence of acute respiratory distress. * Patients who are currently oxygen dependent * Patients who refuse to participate or are deemed incapable of completing the research.

Study Objectives The purpose of this study is to find out if "humanized 3F8" (Hu3F8) when combined with interleukin-2 (rIL2) is safe for treating neuroblastoma and other cancers. A phase 1 study means the investigators are trying to find out what side effects happen when higher and higher doses of a drug are used. The investigators want to find out what effects, good and/or bad, Hu3F8 combined with rIL2 has on cancer. The amount of Hu3F8 that patients gets will depend on when they start treatment on this study. The amount of rIL2 will be the same for all patients. The investigators also want to find out more about how Hu3F8 works and how effective it is in attacking the disease when combined with rIL2. Conditions: Neuroblastoma Intervention / Treatment: DRUG: 3F8 Monoclonal Antibody Combined with Interleukin-2

Inclusion Criteria: * Patients must have either (1) a diagnosis of NB as defined by international criteria,84 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels, or (2) a tumor that is GD2-positive. o A non-NB tumor is defined as GD2-positive by immunostaining with m3F8. If fresh or frozen tumor is not available for immunostaining, patients will be considered eligible if published reports show that >50% of that tumor type is GD2-positive by immunohistochemistry. (Note: Tissues must be fresh/frozen as fixed, paraffin-embedded specimens are unsuitable for anti-GD2 immunostaining). Tumors known to be GD2- positive by this criteria do not need immunostaining. These include: Melanoma (>50%), Desmoplastic small round cell tumors (70%), Osteosarcoma (88%) and Soft tissue sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, and spindle cell sarcoma (93%). * Patients must have either (1) refractory or relapsed high-risk NB (including MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age)resistant to standard therapy\*, or (2) refractory or relapsed GD2-positive tumor after receiving available life-prolonging therapies. \*For NB, standard therapy generally includes 5-8 cycles of high dose induction chemotherapy followed by resection of gross residual tumor, with or without myeloablative chemotherapy with peripheral blood stem cell rescue and radiation therapy to the primary site. There are also salvage chemotherapy regimens for residual disease after standard induction therapy or for relapsed NB. Some examples of these chemotherapy combinations are: high-dose cyclophosphamide, topotecan and vincristine; high-dose cyclophosphamide, irinotecan and vincristine; irinotecan and temozolomide; or ifosfamide, carboplatin and etoposide. * Patients must be older than 1 year of age. * Prior treatment with murine 3F8 is allowed. Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have HAHA antibody titer less than or = to 1300 Elisa units/ml * White blood cell count ≥1000/ul * Absolute neutrophil count ≥500/ul * Absolute lymphocyte count ≥500/ul * Platelet count ≥25,000/ul * No chemotherapy or immunotherapy for a minimum of three weeks prior to study enrollment * Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment * Signed informed consent indicating awareness of the investigational nature of this program. Exclusion Criteria: * Existing major organ dysfunction > grade 2, with the exception of hearing loss and hematologic toxicity (defined as suppression of all subtypes of WBCs, RBCs, and platelets). * Hematologic and primary CNS malignancies * Active life-threatening infection. * Pregnant women or women who are breast-feeding. * Inability to comply with protocol requirements.

Study Objectives This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer who have progressed after previous response to erlotinib hydrochloride therapy. MK2206 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Adenosquamous Lung Carcinoma, Bronchioloalveolar Carcinoma, Large Cell Lung Carcinoma, Lung Adenocarcinoma, Recurrent Non-Small Cell Lung Carcinoma, Squamous Cell Lung Carcinoma Intervention / Treatment: DRUG: Akt Inhibitor MK2206, DRUG: Erlotinib Hydrochloride, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study

Inclusion Criteria: * Patients must have histologically or cytologically confirmed non-small cell lung cancer of any histologic subtype * NOTE: epidermal growth factor receptor (EGFR) mutational status (either wild-type or positive for an activating mutation) will be determined for all patients on this study; commercial assays for EGFR mutation status are allowed; knowledge of EGFR mutational status is not required at the time of protocol entry but should be determined or known before the end of course 2; however, if one of the strata is temporarily closed to accrual, knowledge of EGFR mutational status will be required prior to protocol entry * Patients may have measurable or non-measurable disease; x-rays and/or scans for disease assessment of measurable disease must have been completed within 28 days prior to registration * Patients must have radiologic or clinical progressive disease following prior benefit (response or stable disease) to EGFR-tyrosine kinase inhibitor (TKI) therapy (e.g., erlotinib) administered either as a single agent or in combination with other agents for at least 12 weeks prior to progression; Note: patients may have received intervening systemic therapy after EGFR-TKI progression); additionally, patients must have documentation of radiographic progression within the preceding three months prior to study entry * Prior cytotoxic chemotherapy is allowed; any number of prior chemotherapy regimens is also allowed; prior cetuximab therapy is also allowed; NOTE: a patient with an EGFR activating mutation who has received EGFR-TKI therapy as first line therapy, but has not received platinum-based chemotherapy, would be considered eligible for this trial * Karnofsky performance status >= 60% * Absolute neutrophil count (ANC) >= 1,500/mcL * Platelet count >= 100,000/mcL * Total bilirubin =< upper institutional normal limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 2.5 x institutional upper limit of normal * Creatinine =< upper institutional normal limits OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Prior to the first patient registration, this study must be institutional review board approved; a copy of the institutional review board (IRB) approval for each site involved must be given to the Data Coordinating Center at City of Hope * Women of childbearing potential and men must use two forms of 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 she or her partner is participating in this study, the patient should inform the treating physician immediately * Patients on coumadin should have their international normalized ratio (INR) monitored at least once per week or more frequently depending on the investigator's judgment; there have been some case reports of increased INR when coumadin is co-administered with erlotinib * Ability to understand and the willingness to sign a written informed consent document * Patients should have tumor tissue (either fresh frozen tumor tissue or paraffin-embedded tumor tissue) available for retrieval; if an endobronchial lesion is present or suspected, bronchoscopy is recommended as a source of fresh tissue; tissue blocks or unstained slides from the time of original diagnosis are acceptable if repeat biopsy is not feasible Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have any ongoing grade 2 or greater toxicity from a prior treatment * Patients may not be receiving any other investigational agents * Patients with symptomatic brain metastases should be excluded from this clinical trial; patients with asymptomatic controlled or treated (e.g., with radiation and/or surgery) brain metastases are otherwise eligible as long as corticosteroids given expressly for brain metastases (mets) have been stopped for at least 14 days * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or erlotinib * Caution must be observed for patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4); although these patients are still potentially eligible, close monitoring is required for toxicity * Preclinical studies demonstrated the potential of MK-2206 for induction of hyperglycemia in all preclinical species tested; patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial * Preclinical studies indicated transient changes in corrected QT (QTc) interval during MK-2206 treatment; prolongation of QTc interval is potentially a safety concern while on MK-2206 therapy; cardiovascular: baseline Fridericia QT (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with this combination * Human immunodeficiency (HIV)-positive patients on combination antiretroviral therapy are ineligible * Prior MK-2206 therapy is not allowed * Patients unable to swallow MK-2206 tablets and erlotinib tables whole are ineligible; (the tablets cannot be crushed or broken)

Study Objectives This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer. Conditions: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer Intervention / Treatment: RADIATION: yttrium Y 90 glass microspheres, OTHER: laboratory biomarker analysis, DRUG: TheraSphere

Inclusion Criteria: * Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings * Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2 * Life expectancy >= 3 months * > 4 weeks since prior radiation, surgery or chemotherapy * Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines * Ineligible for surgical resection Exclusion Criteria: * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL) * Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned) * Any contraindications to angiography and hepatic artery catheterization such as: * History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated * Bleeding diathesis, not correctable by usual forms of therapy * Severe peripheral vascular disease that would preclude catheterization * Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment * Evidence of pulmonary insufficiency * Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow * Significant extrahepatic disease representing an imminent life-threatening outcome * Active uncontrolled infection * Significant underlying medical or psychiatric illness * Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk * Pregnancy

Study Objectives The independent impact of surgeon volume on outcome of patients undergoing pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of pancreatic fistula rate was found in the high-volume surgeon group in comparison with low-volume surgeon group. However, no difference between groups was found in mortality, major complications, and hospital stay. Conditions: Pancreatic Cancer, Pancreatic Surgery Intervention / Treatment: PROCEDURE: Pancreaticoduodenectomy

Inclusion Criteria: * Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009 Exclusion Criteria: * Other type of surgery

Study Objectives Jakavi® therapy for polycythemia vera (PV) has so far been studied exclusively in clinical trials and at selected clinical trial centres. This observational study is intended to document the therapy of PV in daily practice with a broad patient population and a geographically representative selection of German centres (both hospitals and practices). The prospective mapping of daily practice reality is thus the main goal of this project. Conditions: Polycythemia Vera Intervention / Treatment: OTHER: Jakavi

Inclusion Criteria: * Adult male and female patients with PV for whom Jakavi® therapy is indicated according to the European summary of product characteristics * Patients who have been informed about this NIS and gave written consent

Study Objectives This is a Phase 1b, dose escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. The investigators are also trying to determine the best dose level of CRLX101 to give in combination with bevacizumab. About 22 subjects will be enrolled in this study at the University of Pennsylvania. Conditions: Renal Cell Carcinoma Intervention / Treatment: DRUG: CRLX101 (Cerulean), DRUG: Bevacizumab

Inclusion Criteria: * Patients must have histologically confirmed metastatic or locally advanced renal cell carcinoma that is unresectable. * Patients must have disease that is evaluable by the Response Evaluation Criteria in Solid Tumors guidelines (RECIST), v1.1. Disease sites must be assessed within 4 weeks of study entry. * Patients must have been treated with at least one prior conventional molecularly targeted therapy in a non-adjuvant setting. Conventional molecularly targeted therapy will be defined as including pazopanib, sorafenib, sunitinib, temsirolimus, axitinib, or everolimus. * A two week wash out is required between the last dose of molecularly targeted therapy and baseline correlative studies (124I-cG250 PET/CT and bone marrow biopsy). If no baseline correlative studies will be performed, a wash out of 1 week will be required prior to the commencement of study therapy. Toxicities from prior therapy must be resolved to grade 1 or less prior to the start of study therapy. * Patients may have been treated with surgery or not (i.e., cytoreductive nephrectomy not required), radiation therapy, chemotherapy, cytokine therapy including interferon alpha and interleukin-2. * Patients with treated brain or spinal-associated metastases are eligible but must have concluded dexamethasone therapy and be considered neurologically stable. * Age greater or equal to 18 years. * ECOG performance status less than 1 (Karnofsky greater than 70%) * Life expectancy greater than 3 months. * Patients must have normal organ and marrow function * The effects of CRLX101 and bevacizumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of administration of this combination therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of administration of this combination therapy. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have had conventional chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not yet recovered to grade 1 or less prior treatment-related adverse events. * Patients who have had major surgery within the last 4 weeks. * Prior treatment with bevacizumab or topoisomerase I therapy. * Patients who are receiving any other investigational therapeutic agent. * History of allergic reactions attributed to any of the experimental compounds examined in this study. * No other active malignancy (inactive / without progression for at least 6 months and no progression anticipated). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * History of non-healing wounds or ulcers. * Pregnant or nursing patients as stated above. Agents examined in this clinical trial carry the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated on study. * Bevacizumab has been associated with the development of treatment-related hypertension that can become urgent or emergent. Evidence of uncontrolled hypertension in patients prior to study enrollment will preclude enrollment onto this study until blood pressure is controlled. Uncontrolled hypertension is defined as the presence of systolic blood pressure greater or equal to 150 mmHg or diastolic blood pressure greater or equal to 100 mmHg measured on two separate occasions. * Patients with known HIV or with solid organ transplant (because of potential additional risk for cytopenias).

Study Objectives Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin with that of combined letrozole-pioglitazone in ovulation induction in CC-resistant PCOS women Conditions: Polycystic Ovary Syndrome, Infertility Intervention / Treatment: DRUG: letrozole-metformin, DRUG: letrozole-metformin-pioglitazone, RADIATION: transvaginal ultrasound, OTHER: laboratory investigations

Inclusion Criteria: * 20-40 years old * PCOS infertile women resistant to CC for 3 cycles Exclusion Criteria: * Presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction * Use of gonadotropins before * Previous ovarian drilling * Presence of urinary symptoms especially bloody urine

Study Objectives OBJECTIVES Primary objective: The primary objective of the trial is to determine the safety of adjuvant treatment with cisplatin plus gemcitabine for a period of 6 months after curative resection of cholangiocellular carcinoma Secondary objectives: Secondary objectives of the trial are to assess the feasibility and efficacy of the adjuvant therapy and to determine duration of response and patterns of failure compared to historical controls without postoperative treatment Exploratory objectives: To obtain blood samples and tumor tissue after resection for establishment and characterization of new cholangiocarcinoma cell lines and tumor antigens. Other aims are identification of tumor specific antibodies from blood samples, and characterization of tumor antigens with consecutive development of new specific immunological therapies, e.g. cancer-testis antigens (CTA) for tumor vaccination. * Trial with medicinal product Conditions: Cholangiocellular Carcinoma Intervention / Treatment: DRUG: Cisplatin and Gemcitabine

Inclusion criteria * Histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic and hilar tumors). Carcinomas involving the gall bladder are allowed.* Macroscopically complete resection within 8 weeks before start of chemotherapy.* Written informed consent.* Health status: WHO performance status (PS) 0-1* Age >18 years* Adequate renal function (creatinine clearance ≥ 60 ml/min, calculated according to the formula of Cockcroft-Gault)* Adequate hepatic function (bilirubin ≤ 3 x LUN, AP ≤ 5 x LUN, ASAT ≤ 5 x LUN)* Adequate hematologic function: neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, Hb ≥ 9,5 mg/dl* Patient compliance and geographic proximity allowing proper staging, treatment and follow-up.* Women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during participation in the trial or during the 12 months thereafter. A negative pregnancy test before inclusion into the trial is required for women < 50 years. Men who agree not to father a child during participation in the trial or during the 12 months thereafter. Exclusion criteria * Pregnancy or breastfeeding women* Previous malignancy within 5 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer* neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, Hb < 9,5 mg/dl* bilirubin > 3 x LUN, ALAT > 5 x LUN, ASAT > 5 x LUN* Creatinine clearance < 60 ml/min, calculated according to the formula of Cockcroft-Gault* Prior chemotherapy with gemcitabine* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmias)* Psychiatric disorder precluding understanding of information of trial related topics and giving informed consent* Active uncontrolled infection* Preexisting peripheral neuropathy (> grade 1)* Serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)* Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry* Known hypersensitivity to the study drugs

Study Objectives The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized. Conditions: Adenocarcinoma of the Pancreas, Pancreatic Cancer, Advanced Cancer, Digestive System Neoplasms, Pancreatic Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Endocrine System Diseases, Pancreatic Diseases Intervention / Treatment: DIETARY_SUPPLEMENT: Ocoxin-Viusid®

Inclusion Criteria: * Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years. * Patients that meet the diagnostic criteria. * Patients with general health according to Karnofsky ≥70 %. * Life expectancy greater than or equal to 3 months. * Patients eligible to receive chemotherapy. * Patients who have signed the informed consent. * Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy: * Hemoglobin ≥ 90 g / l. * Total Leukocyte Count ≥ 3.0 x 109 / L. * Absolute Neutrophil Count ≥1.5 x 109 / L. * Platelet count ≥100 x 109 / L. * Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution. * TGO and TGP values ≤2.5 times the upper limit of the normal interval established in the institution. * Creatinine values within the normal limits of the institution. Exclusion Criteria: * Pregnant or lactating patients. * Patients with known hypersensitivity to any of the active ingredients of the chemotherapy used * Patients who are receiving another product under investigation. * Patients with decompensated intercurrent diseases, including: hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial. * Patients with brain metastases. * Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up. It is planned to include a total of 30 patients in the study, taking into account 10% of losses.

Study Objectives The purpose of the study is to evaluate the pharmacokinetics and safety from the mixture of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC) delivery (Part 1) and CF (co-formulated daratumumab and rHuPH20 preparation) administration via SC delivery of daratumumab (Part 2) and to evaluate the safety of Dara-CF 1800 milligram (mg) SC delivery without pre-dose and post-dose corticosteroids (Part 3). Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Daratumumab Subcutaneous (SC) Administration, DRUG: Recombinant Human Hyaluronidase [rHuPH20]) SC Administration

Inclusion Criteria: * Participants proven to have multiple myeloma (MM) diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria * Measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level >=1.0 gram/deciliter \[g/dL\] or urine M-protein level greater than or equal to (>=) 200 milligram\[mg\]/24 hours\[hrs\]; or (b) IgA, IgD, or IgE multiple myeloma (serum M-protein level >= 0.5 g/dL or urine M-protein level >= 200 mg/24 hrs); or (c) light chain multiple myeloma (serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Pretreatment clinical laboratory values must meet protocol-defined parameters during the Screening phase * Man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use a barrier method of birth control example (eg), either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the final dose of study drug * Relapsed or refractory disease. Relapse is defined as progression of disease after an initial response to previous treatment, more than 60 days after cessation of treatment. Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment * Prior treatment with less than or equal to (>=) 2 treatment lines of anti-myeloma therapy. Prior lines of therapy must include a proteasome inhibitor (PI) (eg, bortezomib, carfilzomib) and an immunomodulatory drug (IMiD) (example, thalidomide, lenalidomide, pomalidomide) in any order during the course of treatment. Each prior line of therapy may consist of one or more agents and may include induction, hematopoietic stem cell transplantation, and/or maintenance therapy. Radiotherapy, bisphosphonates, or a single short course of steroids is not considered a prior line of therapy Exclusion Criteria: * Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously * Participant has received anti-myeloma treatment within 2 weeks before Cycle 1 Day 1 * Participant has previously received an allogenic stem cell transplant; or participant has received autologous stem cell transplantation (ASCT) within 12 weeks before Cycle 1 Day 1 * Participant has a history of malignancy (other than multiple myeloma) within 5 years before Cycle 1 Day 1 (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence) * Participant is exhibiting clinical signs of meningeal involvement of multiple myeloma

Study Objectives In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m² augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before transplantation and lenalidomide maintenance after transplantation. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Lenalidomide, Dexamethasone, DRUG: Lenalidomide, Dexamethasone, PBSCT

Inclusion Criteria: * Understand and voluntarily sign an informed consent form. 2. Age 60-75 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Symptomatic MM requiring therapy. 5. Measurable monoclonal protein in serum and/or urine 6. Monoclonal plasma cells in the bone marrow >= 10% and/or biopsy-proven plasmacytoma 7. Myeloma-related organ dysfunction, at least one of \[C\] Calcium elevation in the serum (> 11.5 mg/dL or > 2.65 mmol/l) \[R\] Renal insufficiency (creatinine > 173 μmol/l or > 2 mg/dL) \[A\] Anemia (Hb < 10 g/dL or 2 g/dL < normal) \[B\] Bone lesions or general osteoporosis 8. ECOG PS of <= 2 ... 9. Laboratory test results within these ranges within 1 week prior to randomization: * ANC >= 1.0 x 109/L. * Platelet count >= 75 x 109/L or in case of bone marrow infiltration with myeloma cells >= 30 x 109/L. * Total bilirubin <= 2 mg/dL. * AST (SGOT) and ALT (SGPT) <= 3 x ULN. 8. Female subjects of childbearing potential must: o Understand the study drug is expected to have a teratogenic risk o Agree to use, ..., effective contraception without interruption,... o Understand that even if she has amenorrhea, she must follow all the advice on effective contraception. o She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy o Agree to have a medically supervised pregnancy test ... * Male subjects must o Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug therapy ... * Agree not to donate semen during study drug therapy and for one week after end of study drug therapy. * All subjects must * Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy. * Agree not to share study drug with another person and to return all unused study drug to the investigator. 9. Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. 10. Able to receive antithrombotic prophylaxis (...). 11. Life-expectancy > 3 months. Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.* Pregnant or lactating females* Any condition, incl. the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.* Patient currently is enrolled in another clinical research study or has been enrolled ...within 4 weeks before randomization and/or is receiving an investigational agent for any reason ...* Known hypersensitivity to thalidomide, dexamethasone, or melphalan.* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.* Any prior use of lenalidomide.* Concurrent use of other anti-cancer agents or treatments.* Known positive for HIV or active infectious hepatitis, type A, B or C or treponema pallidum* Prior treatment with dexamethasone discontinued because of ≥ grade 3 dexamethasone-related toxicity.* Any prior chemotherapy with the exception of a short course of dexamethasone more than 4 weeks before randomization.* Immunotherapy or antibody therapy within 8 weeks before randomization.* Major surgery within 4 weeks before randomization.* Renal failure requiring dialysis.* Myocardial infarction within 6 months before randomization, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.* Severe pulmonary disease (diffusion capacity < 60% of normal).* Treatment for cancer other than MM within 5 years before randomization, with the exception of basal cell carcinoma or cervical cancer in situ.* Cardiac amyloidosis.* Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.* Any systemic infection requiring treatment.* Unability or unwillingness of the patient to receive antithrombotic prophylaxis. -

Study Objectives The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population. Conditions: Uterine Fibroids Intervention / Treatment: DEVICE: MR-HIFU uterine fibroid treatment

Inclusion Criteria: * Women, age between 18 and 55 years * Weight < 140 kg * Pre- or peri-menopausal * Uterine size < 24 weeks * Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue * Fibroids selected for treatment meeting the following criteria: 1. Total planned ablation volume of all fibroids should not exceed 250 ml, and 2. No more than 5 fibroids should be planned for ablation, and 3. Dominant fibroid (diameter) is greater than or equal to 3 cm, and 4. Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous 5. Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated * MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated * Willing and able to attend all study visits Exclusion Criteria: * Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis) * Desire for future pregnancy * Significant systemic disease, even if controlled * Positive pregnancy test * Hematocrit < 25% * Extensive scarring along anterior lower abdominal wall (> 50% of area) * Surgical clips in the direct path of the HIFU beam * MRI contraindicated * MRI contrast agent contraindicated * Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible) * Calcifications around or throughout uterine tissues * Communication barrier * Suspected malignancy

Study Objectives The treatment landscape of metastatic non small cell lung cancer (NSCLC) is rapidly evolving. There are new diagnostic and treatment options available in the coming months and years. New combination treatments will give different solutions to pneumo-oncologists who might be guided by certain patient and tumor characteristics. The link between patient and tumor characteristics in untreated stage IV non small cell lung cancer (NSCLC) patients and systemic treatment needs further investigation, allowing the identification of possible treatment issues, data gaps and/or areas of improvement. Conditions: Stage IV Non-small Cell Lung Cancer Intervention / Treatment: OTHER: None - Common practice

Inclusion Criteria: * Have voluntarily agreed to participate by giving written informed consent/assent for the trial. * Have a histologically or cytologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) on first-line (1L) systemic treatment. * Have received at least their first dose of the selected systemic treatment and a maximum of 1 cycle of the same treatment. Patients that were selected to receive best supportive care will not have to comply to this inclusion criterion. * Be ≥ 18 years of age on day of signing informed consent. Exclusion Criteria: * Has received prior systemic treatment for their metastatic non-small cell lung cancer (NSCLC) before the first dose of trial treatment. However, subjects who received adjuvant or neoadjuvant therapy during an earlier stage of their disease, but evolved to stage IV, are eligible. * Tyrosine kinase inhibitor (TKI) selected as first-line systemic treatment. * Is participating in an interventional trial or medical need program.

Study Objectives This study assesses the safety and efficacy of TXA for patients treated for pathological femur fractures using modular prosthetics. Conditions: Metastases to Bone Intervention / Treatment: DRUG: Tranexamic acid injection

Inclusion Criteria: * Patological fracture * Arthroplasty using a modular prosthesis. Exclusion Criteria: * threatened fracture * intraoperative blood transfusion * fracture fixation

Study Objectives In the treatment of patient with lymphoma the most common high-dose chemotherapy regimen used prior to autologous transplantation (ASCT) is the BEAM regimen. It consists of four chemotherapy drugs together (BCNU, etoposide, cyclophosphamide, melphalan), whose initial letters are grouped together for BEAM regimen. One of the most common organ damage this intensive treatment is caused by the drug BCNU; it involves a lung injury, which manifests itself in the months after ASCT with increasing shortness of breath and cough, and can result in pulmonary fibrosis. The drug bendamustine is used successfully in different lymphoma types, and its efficacy in lymphoma therapy is well documented. Moreover bendamustine doesn't cause lung injury. Initially experience with bendamustine instead of BCNU - in the so-called BeEAM scheme - shows that this scheme is quite effective and well tolerated, without lung injury. In BeEAM scheme therefore bendamustine replace the BCNU, while the other three drugs are administered in the same dosage and order. The aim of the present study conducted at four centers (Bern and Zurich in Switzerland, Vienna and Linz in Austria) is to compare these two high-dose chemotherapy schemas and to show that the BeEAM scheme causes significantly less lung injury than the BEAM regimen. Conditions: Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell Intervention / Treatment: DRUG: BeEAM, DRUG: BEAM

Inclusion Criteria: * Written Informed Consent * Chemosensitive diffuse large B-cell lymphomas (DLBCL), follicular lymphomas (FL), and mantle cell lymphomas (MCL) in first or second remission * Aged between 18 years and 75 years * Neutrophils ≥ 1000/μl; Platelets ≥ 100 x 109/L Exclusion Criteria * Acute uncontrolled infection * Clinically significant concomitant disease states * Hematopoietic cell transplantation comorbidity index (HCT-CI) > 5 * Previous or concurrent malignant disease with the exception of basalioma/spinalioma of the skin or early-stage cervix carcinoma * Known or suspected non-compliance * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Major coagulopathy or bleeding disorder * Major surgery less than 30 days before start of treatment * Contraindications to the class of drugs under study, known hypersensitivity or allergy to class of drugs or the investigational product * Women who are pregnant or breast feeding; Women with the intention to become pregnant during the course of the study * Lack of safe contraception * Participation in another study with investigational drug within the 30 days preceding and during the present study * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons

Study Objectives This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. Conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aggressive Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Indolent Non-Hodgkin Lymphoma, Lymphoma, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Chronic Lymphocytic Leukemia, Recurrent Follicular Lymphoma, Recurrent Lymphoplasmacytic Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, Refractory Follicular Lymphoma, Refractory Hodgkin Lymphoma, Refractory Lymphoplasmacytic Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Small Lymphocytic Lymphoma, T-Cell Non-Hodgkin Lymphoma Intervention / Treatment: PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, DRUG: Cyclophosphamide, DRUG: Cyclosporine, DRUG: Fludarabine Phosphate, OTHER: Laboratory Biomarker Analysis, DRUG: Mycophenolate Mofetil, RADIATION: Total-Body Irradiation, PROCEDURE: Umbilical Cord Blood Transplantation

Inclusion Criteria: * Patients > 70 may be considered if performance status > 80% or Eastern Cooperative Oncology Group (ECOG) =< 1 and comorbidity score < 3; these patients must be discussed with the principal investigator (PI), Rachel Salit prior to enrollment * Adequate cardiac function defined as absence of decompensated congestive heart failure, or uncontrolled arrhythmia and: * Left ventricular ejection fraction >= 35% or * Fractional shortening > 22% * Adequate pulmonary function defined as diffusion capacity of carbon monoxide (DLCO) > 30% predicted, and absence of oxygen (O2) requirements * Adequate hepatic function; patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease will be excluded * Adequate renal function defined as creatinine =< 2.0 mg/dl (adults) or creatinine clearance > 40 ml/min (pediatrics) * All adults with a creatinine > 1.2 or a history of renal dysfunction must have estimated creatinine clearance > 40 ml/min * Performance status score: Karnofsky (for adults) >= 60 or ECOG 0-2; Lansky (for children) score >= 50 * If recent mold infection, e.g., Aspergillus, must be cleared by infectious disease * Second hematopoietic cell transplant: Must be >= 3 months after prior myeloablative transplant * Patients who have received < 2 cycles of multiagent chemotherapy and patients who have received no multiagent chemotherapy within the 3 months previous to umbilical cord blood transplant (UCBT) as well as patients experiencing graft failure following previous allogeneic transplant * Acute myeloid leukemia/acute lymphoblastic leukemia, including biphenotypic acute leukemia or mixed-lineage leukemia: Must have < 5% morphologic marrow blasts in an evaluable marrow (> 25% of normal cellularity for age) collected less than one month prior to start of conditioning; patients persistently aplastic for greater than one month since completing last chemotherapy are also eligible with the approval of the PI or designee * Chronic myelogenous leukemia: All types, except refractory blast crisis; chronic phase patients must have failed or been intolerant to Gleevec or other tyrosine kinase inhibitors; at time of transplant, patients must have < 5% blasts in an evaluable marrow (> 25% of normal cellularity for age) by morphology within the bone marrow * Myelodysplastic syndrome (MDS): Any subtype; morphologic blasts must be less than 5% in an evaluable marrow (> 25% of normal cellularity for age); if blasts are 5% or more, patient requires induction chemotherapy pre-transplant to reduce blast count to less than 5%; patients who have a hypocellular marrow in the absence of excess blasts that is related to the underlying disease or as a result of treatment for MDS may also be eligible with the approval of the PI or designee * Large-cell lymphoma and aggressive T-cell lymphoma: With chemotherapy sensitive disease that has failed autologous transplant or patients who are ineligible for an autologous transplant; chemotherapy sensitive disease is defined as >= 50% reduction in the size of the tumor with the chemotherapy regimen immediately preceding transplant * Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Must be refractory to fludarabine (fludarabine phosphate) or fail to have a complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog, e.g. cladribine \[2-CDA\], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog) * Hodgkin disease: Must have received and failed frontline therapy * Follicular lymphoma, marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma, mantle-cell lymphoma, and indolent T-cell lymphomas: Must have progressed with the most recent remission duration being < 6 months; patients with bulky disease should be considered for debulking chemotherapy before transplant; patients with refractory disease are eligible, unless they have bulky disease and an estimated tumor doubling time of less than one month * Multiple myeloma: Must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative hematopoietic cell transplant (HCT) is permitted * Myeloproliferative syndromes * DONOR: Cord blood (CB) donor selection will be based on institutional guidelines and in general should be selected to optimize both human leukocyte antigen (HLA) match and cell dose; additionally, CB grafts shall consist of one or two CB donors based on, but not exclusively determined by, cell dose (total nucleated cell \[TNC\]/kg and CD34/kg), HLA matching and disease status and indication for transplant; attending preference will be allowed for single versus double unit as well as the degree of mismatching based on patient specific factors, as long as the following minimum criteria are met: * HLA matching * Minimum requirement: The CB graft(s) must be matched at a minimum at 4/6 HLA-A, B, DRB1 loci with the recipient. Therefore 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution A, B antigen and DRB1 allele typing for determination of HLA-match is allowed * HLA-matching determined by high-resolution typing is allowed per institutional guidelines as long as the minimum criteria are met * Selection of two CB units is mandatory when a single cord blood unit does not meet the following criteria: * Match grade 6/6; TNC Dose >= 2.5 x 10\^7/kg * Match grade 5/6 or 4/6; TNC dose >= 4.0 (+/- 0.5) x 10\^7/kg * If two CB units are used, the total cell dose of the combined units must be at least 3.0 x 10\^7 TNC per kilogram recipient weight based on pre-cryopreservation numbers, with each CB unit containing a MINIMUM of 1.5 x 10\^7 TNC/kg * The minimum recommended CD34/kg cell dose should be 2 x 10\^5 CD34/kg, total dose from a single or combined double * The unmanipulated CB unit(s) will be Food and Drug Administration (FDA) licensed or will be obtained under a separate investigational new drug (IND), such as the National Marrow Donor Program (NMDP) Protocol 10-CBA conducted under BB IND-7555 or another IND sponsored by (1) a participating institution or (2) an investigator at FHCRC or one of the participating institutions * FHCRC only: Up to 5% of cord blood product, when ready for infusion, may be withheld for research purposes as long as thresholds for infused TNC dose are met; threshold for double unit transplantation is >= 3.0 x 10\^7/kg; these products will be used to conduct studies involving the immunobiology of double cord transplantation and kinetics of engraftment Exclusion Criteria: * Patients with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor * Pregnancy or breastfeeding * Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology * Uncontrolled viral or bacterial infection at the time of study enrollment * Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval * Active central nervous system malignancy * Patients who have received >= 2 cycles of multiagent chemotherapy within the 3 months previous to UCBT; patients who have had previous autologous transplant within 12 months of UCBT are excluded regardless of history of recent treatment * DONOR: Any cord blood units with < 1.5 x 10\^7 total nucleated cells per kilogram recipient weight * DONOR: Any cord blood units without the full maternal testing and negative results for hepatitis A, B, C, HIV, and human T-lymphotropic virus (HTLV-1) viruses; any additional available virology results on the unit itself will be reviewed but are not mandated, complete or always available; cord blood units are presumed to be cytomegalovirus (CMV) negative regardless of serologic testing due to passive transmission of maternal CMV antibodies

Study Objectives This study will assess the effect of multi-dose administration of itraconazole on the single-dose pharmacokinetics (PK) of alisertib. Conditions: Advanced Solid Tumors, Relapsed/Refractory Lymphoma Intervention / Treatment: DRUG: Alisertib, DRUG: Itraconazole

Inclusion Criteria * Male and female participants 18 years of age or older.* Participants with histologic or cytologic diagnosis of advanced or metastatic solid tumors or lymphomas for which no curative or life-prolonging therapies exist.* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria * Systemic treatment with moderate or strong CYP3A inhibitors or inducers must be discontinued at least 14 days before the first dose of alisertib, and the use of these agents is not permitted during the study (except for the protocol-specified administration of itraconazole).* Known gastrointestinal (GI) abnormality (including recurrent nausea or vomiting) or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib.* Known hypersensitivity or intolerance to itraconazole or similar class agents.

Study Objectives The purpose of this study is to study whether immune cells capable of killing tumors that express proteins associated with paraneoplastic neurologic syndrome (PNS) can be found in small cell lung cancer and ovarian cancer patients. The presence of these cells may play a role in tumor immunity in these patients. The protocol involves neurological examinations and collection of blood. Conditions: Cancer Intervention / Treatment:

Inclusion Criteria: * Males and females ages 25 -75* If leukapheresis: Hepatitis B surface antigen negative if tested\* Hepatitis C antibody negative if tested\* HIV antibody negative if tested\* Venereal disease reaction level (VDRL) negative if tested\* No known IV drug users Hemoglobin > 8.5 White blood cell count > 3,800 Platelets > 120,000 International normalized ratio (INR) < 2 (verified only if clinically indicated)* If large blood draw (1/2 to 1 unit) in lieu of leukapheresis: Hepatitis B surface antigen negative if tested\* Hepatitis C antibody negative if tested\* HIV antibody negative if tested\* VDRL negative if tested\* No known IV drug users HgB > 10.0 WBC > 3,800 Platelets > 120,000 INR < 2 (verified only if clinically indicated) Exclusion Criteria: No known neurologic disease 2. No known central nervous system (CNS) metastasis on clinical exam 3. No chemotherapy within 1 month 4. No New York Heart Association class III/IV status 5. No pulmonary disease which limits daily activities 6. No anticoagulation therapy

Study Objectives The purpose of this study is to assess the long-term outcome in a cohort of Gardner-Syndrome patients receiving prophylaxis and treatment for intestinal and non-intestinal tumors. Conditions: Gardner Syndrome, Colorectal Carcinoma, Desmoid Tumor Intervention / Treatment:

Inclusion Criteria: * family with an identical adenomatous polyposis coli (APC-) germ line mutation Exclusion Criteria: * negative testing for adenomatous polyposis coli (APC-) germ line mutation

Study Objectives The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer. Conditions: Metastatic Breast Cancer Intervention / Treatment: DRUG: Placebo, DRUG: Veliparib, DRUG: Carboplatin, DRUG: Temozolomide, DRUG: Paclitaxel

Inclusion Criteria: * Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic. * Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent. * Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation. * If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy. * Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. * Subject must have adequate bone marrow, renal and hepatic function. * Subject must not be pregnant or plan to conceive a child. Exclusion Criteria: * Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1. * More than 2 prior lines of cytotoxic chemotherapy. * Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor. * Prior taxane therapy for metastatic breast cancer. * A history of or evidence of brain metastases or leptomeningeal disease. * A history of uncontrolled seizure disorder. * Pre-existing neuropathy from any cause in excess of Grade 1. * Known history of allergic reaction to cremophor/paclitaxel. * Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance. * Pregnant or breastfeeding.

Study Objectives Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in mesothelioma patients. However, median survival of this patient group was only about 12 months. With intent to find more effective treatment the investigators performed phase II study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore such regiment in patients with malignant pleural mesothelioma (MPM) as well. Conditions: Malignant Pleural Mesothelioma Intervention / Treatment: DRUG: Prolonged 6-hr infusion of gemcitabine

Inclusion Criteria: * Biopsy-proven diagnosis of malignant pleural mesothelioma * Inoperable for anatomic or physiological reason * Measurable and previously unirradiated lesion * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 * Adequate haematopoietic, liver, and kidney function. * Signed informed consent for participation in the trial Exclusion Criteria: * Significant medical co-morbidity * Pregnant or lactating women * History of the cancer in the previous 10 years or breast cancer ever.

Study Objectives The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm Conditions: Quality of Life Intervention / Treatment: PROCEDURE: modified BII+Braun

Inclusion Criteria: * 18<age<75 * Gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy * The preoperative clinical stage is T1-4a,N0-3,M0(According to AJCC- 7th TNM tumor stage) * It is expected that the results of R0 surgery can be obtained by performing distal gastrectomy and D2 lymph node dissection * Preoperative ECOG performance status score 0/1 * Nutrition risk screening（NRS2002） * Preoperative ASA score I-III * Patient informed consent Exclusion Criteria: * Pregnancy or breastfeeding women * Severe mental illness * History of upper abdominal surgery * History of gastric surgery (including ESD/EMR for gastric cancer) * 3 years of history of other malignant diseases； * Gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment * A history of unstable angina or myocardial infarction within 6 months * History of cerebral infarction or cerebral hemorrhage within 6 months * There is a history of sustained systemic corticosteroid treatment within 1 month * Needs simultaneous surgical treatment of other diseases； * Gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery * Pulmonary function test FEV<1 predicted value 50%

Study Objectives The purpose of this study is to determine the safest and most effective oral dose combinations of sorafenib and irinotecan in pediatric patients with solid tumors, i.e. relapsed or refractory. Conditions: Rhabdomyosarcoma and Other Soft Tissue Sarcomas, Ewing's Sarcoma Family of Tumors, Osteosarcoma, Neuroblastoma, Brain Tumors Intervention / Treatment: DRUG: sorafenib, DRUG: irinotecan

Inclusion Criteria: * AGE: >=2 year and <22 years of age. * DIAGNOSIS: solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors and brain tumors. * MEASURABLE/EVALUABLE DISEASE: Patients must have measurable or evaluable disease. * THERAPEUTIC OPTIONS: * The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities. * PRIOR THERAPY: * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrolling on this study. * No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study enrollment. * Myelosuppressive chemotherapy: The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks prior to study entry. * Immunotherapy: The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 4 weeks prior to study entry. * Biologic (anti-cancer agent): The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or tyrosine kinase inhibitors) must be at least 7 days prior to study entry. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair. * Investigational anti-cancer agent: The last dose of all investigational agents must be at least 30 days prior to study entry. * Radiation therapy: The last dose of radiation to more than 25% of marrow containing bones (pelvis, spine, skull) must be at least 4 weeks prior to study entry. The last dose of all other local palliative (limited port) radiation must be at least 2 weeks prior to study entry. * Stem Cell Transplantation. At least 2 months post-autologous stem cell transplant or at least 3 months post-allogeneic transplant and recovered from toxicities without evidence of graft versus host disease. * Prior camptothecins: Patients who previously received irinotecan as front line treatment or in an adjuvant setting are eligible if they did not experience severe toxicities (defined as grade 4 non-hematologic toxicity or failure to recover from any non-hematologic or hematologic toxicity within 6 weeks of receiving the drug) possibly, probably or definitely related to the agent, and they did not experience tumor progression during the time they received the agent. Patients who previously received topotecan are eligible. * Growth Factors. The last dose of colony stimulating factors, such as filgrastim, sargramostim, and erythropoietin, must be at least 1 week prior to study entry, the last dose of long-acting colony stimulating factors, such as pegfilgrastim, must be at least 2 weeks prior to study entry. * CONCURRENT THERAPIES: * No other anti-cancer therapy (chemotherapy, biological therapy, radiation therapy) is permitted. * PERFORMANCE STATUS: * Patients > 10 years old must have a Karnofsky performance level >= 50%, and children <= 10 years old must have a Lansky performance level >= 50%. * Patients who are unable to walk because of paralysis or motor weakness, but who are up in a wheelchair will be considered ambulatory for the purpose of calculating the performance score. * HEMATOLOGIC FUNCTION: * Peripheral absolute neutrophil count (ANC) of >=750/mcL * Platelet count >=75,000/mcL without administration of platelets * HEPATIC FUNCTION: * Total bilirubin must be gender * SGPT (ALT) must be - Serum albumin >= 2 g/dL * RENAL FUNCTION: Age-adjusted normal serum creatinine (see table below) OR a creatinine clearance >=60 mL/min/1.73 m2. Age Maximum Serum Creatinine (Years) (mg/dl) Male Female 2 to less than 6 years 0.8 0.8 6 to less than 10 years 1 1 10 to less than 13 years 1.2 1.2 13 years to less than 16 years 1.5 1.4 Greater than or equal to 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR (Schwartz et.al. J Peds 106:522, 1985) utilizing child length and stature data published by the CDC. * ADEQUATE PULMONARY FUNCTION: Defined as no dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air if there is clinical indication for determination (cough, etc). * Normal serum amylase and lipase * PT and PTT <= 1.5 times the upper limit of normal for age (including patients on prophylactic anticoagulation). Prophylactic anticoagulation as described below is permitted: * Low dose warfarin with PT-INR <= 1.5 x ULN. For subjects receiving warfarin, the PT-INR should be measured prior to initiation of trial drugs and should be monitored at least weekly, or as defined by the local standard of care, until it is stable. * Low-dose aspirin (<= 100 mg daily). * Prophylactic doses of heparin. * Blood pressure (BP) <= the 95th percentile for age, height and gender and not receiving anti-hypertensive medications or well controlled on antihypertensive medications for one week. Blood pressure will be recorded as the average of 2 measurements separated by at least 2 minutes. If the second value is more than 5 mmHg different from the first, continued measurements should be made every 2 minutes until a stable value is attained. The recorded value should be the average of the last two measurements obtained. Blood pressure is to be measured preferably in the right arm with an appropriate sized cuff, taken in a seated position after 3 minutes of rest. Oscillometric blood pressure measurements that exceed the 95th percentile should be confirmed by auscultation. * BIRTH CONTROL: Patients of childbearing or child-fathering potential will be required and must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study. Exclusion Criteria: * Clinically significant unrelated systemic illness, such as serious infections, hepatic,renal or other organ dysfunction, which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate the agents used in this trial or are likely to interfere with the study procedures or results. * Patients with known intra-axial metastatic central nervous system lesions. * Pregnant or breast-feeding females are excluded because of the potential harmful effects of sorafenib and irinotecan on a developing fetus or nursing child. * Patients currently receiving other anticancer agents or radiation therapy. * Patients currently receiving other investigational agents. * Prior treatment with a sorafenib containing regimen. * Inability to swallow pills. * Evidence of bleeding diathesis and/or on therapeutic anti-coagulation medications. * Patients with known Gilbert syndrome. * Patients who take cytochrome P450 enzyme-inducing antiepileptic agents (phenytoin, carbamazepine, phenobarbitol), rifampin, erythromycin, azithromycin, azole antifungals, grape fruit juice or St. Johns Wort. Patients must have discontinued these medications at least 7 days prior to enrollment of trial. * Patients with baseline hypertension (>=95th BP percentile for age, height and gender) and not controlled on anti-hypertensive medications. * Patients with a malabsorption syndrome. * Patients with known human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection. * Patients with serious non-healing wound, ulcer, or bone fracture. * Patients with thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. * Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy,unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months * Patients who have undergone major surgery, open biopsy or significant traumatic injury within 4 weeks of study enrollment. * Patients with known or suspected allergy to any agent given in the course of this trial.

Study Objectives This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib. Conditions: Malignant Melanoma Intervention / Treatment: DRUG: Vemurafenib, DRUG: Dacarbazine

Inclusion Criteria: * adults, >=18 years of age * metastatic melanoma, stage IIIC or IV (AJCC) * treatment-naïve (no prior systemic anticancer therapy) * positive for BRAF V600E mutation * measurable disease by RECIST criteria * negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion Exclusion Criteria: * active central nervous system metastases * history of carcinomatous meningitis * severe cardiovascular disease within 6 months prior to study drug administration * previous malignancy within 5 years prior to study, except for basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix

Study Objectives This was a Phase 1, dose-escalation, non-randomized, open-label, single-center study of DS-8895a in patients with advanced or metastatic Ephrin type-A receptor 2 (EphA2)-positive cancers. The primary study objective was to determine the safety of DS-8895a, with secondary objectives of determining the biodistribution, tumor uptake (bioimaging), pharmacokinetics (PK), antitumor and pharmacodynamic response, and correlations between pharmacodynamics and clinical outcomes, as appropriate. Conditions: Malignant Solid Tumor, Metastatic EphA2 Positive Cancer Intervention / Treatment: DRUG: DS-8895a 1 mg/kg, DRUG: DS-8895a 3 mg/kg, DRUG: DS-8895a 10 mg/kg

Inclusion Criteria: * Advanced or metastatic EphA2 positive cancer (based on immunohistochemistry of archived or fresh tumor tissue).* Malignant tumor that was refractory to standard treatment.* At least one reference tumor > 1 cm in size for assessment of tumor uptake of \^89Zr-Df-DS-8895a.* Expected survival of at least 3 months.* Eastern Cooperative Oncology Group performance status ≤ 1.* Within the last week prior to the first study drug administration, laboratory parameters for vital functions were to be in the normal range. Out-of-range values that were not clinically significant were permitted, except that the following parameters were to be in the specified ranges: * Neutrophil count ≥ 1.5 x 10\^9/L * Platelet count ≥ 90 x 10\^9/L * International normalized ratio ≤ 1.5 * Serum aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x the upper limit of normal (ULN); ≤ 5 x ULN if liver metastases * Serum bilirubin ≤ 1.5 x ULN* Calculated creatinine clearance ≥ 55 mL/min.* Age ≥ 18 years.* Able and willing to give valid written informed consent. Exclusion Criteria: * Active central nervous system metastases. Definitively treated metastases were allowed if stable for 6 weeks off therapy.* Known immunodeficiency or human immunodeficiency virus positivity.* Serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would have interfered with the ability of the patient to fulfill the study requirements.* Other malignancy, apart from non-melanoma skin cancer, within 3 years prior to the first study drug administration that in the opinion of the investigator had > 10% risk of relapse within 12 months.* Significant allergic reaction to prior antibody infusions.* Chemotherapy, radiotherapy, or investigational agent within 4 weeks prior to the first study drug administration.* Regular corticosteroid, non-steroidal anti-inflammatory drug (other than paracetamol or low-dose aspirin) or other immunosuppressive treatment within 3 weeks prior to the first study drug administration (intermittent dosing permitted if less than 4 doses within a 3-day period).* Mental impairment that could have compromised the ability to give informed consent and comply with the requirements of the study.* Lack of availability for clinical follow-up assessments.* Pregnancy or breastfeeding.* Women of childbearing potential: Refusal or inability to use effective means of contraception.

Study Objectives Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors. Conditions: Cancer, Insomnia Intervention / Treatment: BEHAVIORAL: Mindfulness-Based Stress Reduction, BEHAVIORAL: Cognitive Behavior Therapy

Inclusion Criteria: * English speaking * Non metastatic cancer * 1 month post chemotherapy/radiation treatment (hormone treatment okay) * Diagnosis of Primary or Secondary Insomnia Exclusion Criteria: * Presence of another sleep disorder * Presence of another Axis I diagnosis (not in remission) * Inability to attend at least 5 out of the 8 treatment sessions * Randomization Refusal * Previous participation in CBT-I or MBSR * Shift work

Study Objectives RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain therapy in treating chronic pain and numbness caused by chemotherapy in patients with cancer. Conditions: Cancer-related Problem/Condition, Neurotoxicity, Pain, Peripheral Neuropathy Intervention / Treatment: OTHER: electrical stimulation pain therapy, OTHER: questionnaire administration

Inclusion Criteria: * CIPN neuropathy: received, or currently receiving, neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezomib) * Pain or symptoms of peripheral neuropathy of >= 1 months duration attributed to chemotherapy-induced peripheral neuropathy * OR pain of the other types including chemotherapy-induced peripheral neuropathy, numbness predominant; post mastectomy pain; post surgical pain; post herpetic neuropathy; post radiation pain; other (vertebral compression, fracture, miscellaneous) * The pain must have been stable for at least 2 weeks * An average daily pain rating of >= 5 out of 10, using the pain numerical rating scale (NRS: 0 is no pain and 10 is worst pain possible); or numbness that bothers the patient at least "a little bit" on the CIPN-20 * Life expectancy >= 3 months * ECOG performance status 0, 1, or 2 Exclusion Criteria: * Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, abstinence, etc.) * Use of an investigational agent for pain control concurrently or =< 30 days * History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation * Patients with implantable drug delivery systems, e.g., Medtronic Synchromed * Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates (metal implants for orthopedic repair, e.g., pins, clips, plates, cages, joint replacements are allowed) * Patients with a history of myocardial infarction or ischemic heart disease within the past six months * Patients with history of epilepsy, brain damage, use of anti-convulsants, symptomatic brain metastases * Prior celiac plexus block, or other neurolytic pain control treatment within 4 weeks * Other identified causes of painful paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy) * Skin conditions such as open sores that would prevent proper application of the electrodes * Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study

Study Objectives The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors. Conditions: Solid Tumors Intervention / Treatment: DRUG: Brivanib

Inclusion Criteria: * Patients must have measurable disease * Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator * ECOG PS: 0-1 Exclusion Criteria: * Subjects with centrally located squamous cell carcinoma of the lung

Study Objectives In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. It has agglomerated homogeneous tissue samples to identify new biomarkers for patient diagnosis and follow-up, and may predict the therapeutic response. These knowledge will help to treatment customization. Conditions: Cancer Intervention / Treatment: OTHER: skin biopsy, OTHER: tumor biopsy, OTHER: blood sample

Inclusion Criteria: * Child or teenager aged 2 to <18 * Man, Woman> 18 years old * Patient with one of these situations: * Unusual toxicity in progress or after radiotherapy * Indication of radiotherapy and suspicion of abnormal pathways of response to ionizing radiation - constitutional (genetic disease) or acquired (systemic disease) - which may generate unusual radioinduced toxicity * Patient information and informed consent signed by the patient. For children and teenager : information to parents and obtaining informed consent * Affiliation to a social security scheme. Exclusion Criteria: * Contraindication for skin and / or tumoral biopsy * Contraindication for blood sample of 2.5 ml * Persons deprived of liberty or under supervision

Study Objectives A drug-drug interaction study to investigate the potential pharmacokinetic interaction between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate). Conditions: Pharmacokinetics of MDV3100, Castration Resistant Prostate Cancer (CRPC) Intervention / Treatment: DRUG: MDV3100, DRUG: Pioglitazone, DRUG: Warfarin, DRUG: Omeprazole, DRUG: Midazolam

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features; * Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration); * Progressive disease by prostate specific antigen (PSA) or imaging whether or not after chemotherapy in the setting of medical or surgical castration. Disease progression for study entry is defined as one or more of the following 3 criteria: * PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥1 week between each determination. The PSA value during the pre investigational period should be ≥2 μg/L (2 ng/mL); * Soft tissue disease progression defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease (see Appendix A); * Bone disease progression defined by two or more new lesions on bone scan. Exclusion Criteria: * Confirmed CYP2C8, CYP2C9, or CYP2C19 poor metabolizer status based on genotyping analysis; * Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, and hemoglobin < 5.6 mmol/L (9 g/dL) during the screening period (NOTE: patients may not have received any growth factors or blood transfusions within 7 days prior to the hematologic laboratory values obtained during the screening period); * Total bilirubin > 1.5 times, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal during the screening period; * Creatinine > 177 μmol/L (2 mg/dL) during the screening period; * Albumin < 30 g/L (3.0 g/dL) during the screening period; * Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), 5 α reductase inhibitors (finasteride, dutasteride), estrogens, or chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study; * Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study; * Structurally unstable bone lesions suggesting impending fracture; * History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months prior to enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization)

Study Objectives Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time as operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas undergoing surgery. Conditions: Glioma Intervention / Treatment: DRUG: BLZ-100

Inclusion Criteria: * Male or female subjects aged 18- 75 years.* Subjects must have glioma for which surgical resection is clinically indicated. Grade I, II, III and IV glioma patients will be included (for example glioblastoma, astrocytoma, and oligodendroglioma). Histological confirmation not required prior to surgery. Subjects with recurrent disease will be eligible only if the duration between last brain surgery and scheduled new surgery is ≥3 months. The grade of a recurrent tumor will be presumed that of the primary tumor for purposes of group allocation.* Able to provide written informed consent.* If of child-bearing potential, agree to the continued use of effective contraceptive from study entry (Informed consent) through 30 days after BLZ-100 administration.* Available for all study visits and able to comply with all study requirements Exclusion Criteria: * Evidence of metastatic disease.* Female who is lactating/breastfeeding* Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study.* Karnofsky Performance Status of <60%.* Any of the following laboratory abnormalities at Screening: 1. Neutrophil count <1.5 x 10\^9/L 2. Platelets <75 x 10\^9/L 3. Hemoglobin <10 g/dL (may be determined following transfusion) 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x upper limit of normal (ULN) 5. Total bilirubin >1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction) 6. International Normalized Ratio (INR) >1.5 7. Creatinine >1.5x ULN* Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).* QTc prolongation >450 msec* History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.* Uncontrolled asthma or asthma requiring oral corticosteroids.* Known or suspected sensitivity to MRI contrast agents or excipients in the study drug product.* Known or suspected sensitivity to Indocyanine green (ICG).* Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of start of Screening.* Uncontrolled hypertension.* Receipt of photosensitizing drugs within 30 days of Screening.* Any ongoing medications which might generate fluorescence or according to label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions; Photofrin®; and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix.* Received an investigational drug or device within 30 days of enrollment.* Prior treatment with BLZ-100.* Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data. -

Study Objectives Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length. Conditions: Esophageal Cancer, Cancer of Gastro Esophageal Junction, Palliative Treatment Intervention / Treatment: DEVICE: Partially covered SEMS, DEVICE: Fully covered SEMS

Inclusion Criteria: * Verified Squamous Cell Carcinoma or Adenocarcinoma of esophagus or Gastro Esophageal Junction (GEJ) * Age above 18 years. * Dysphagia scoring grade two or worse * Not amenable for curative treatment * Informed consent to participate Exclusion Criteria: * Concomitant cancer disease * Inability to comply with study protocol * Previous stent treatment * Proximal location of the tumour in the esophagus. * Need for more than one stent deployment.

Study Objectives In the context of radiotherapy, control of breakthrough pain represents a special challenge. Patients undergoing radiotherapy may experience different situations of pain that may be due to the need to remain immobilized during radiotherapy session, the need to wear an immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation after the development of proctitis, or sudden pain during the night causing sleep disturbances. In a survey conducted in radiation oncology services more than half of patients treated with radiotherapy experienced pain, and 39% of patients reported that their pain was not treated properly. This situation may increase the patient's anxiety, dissatisfaction with treatment, affect their quality of life and can even come to refuse radiotherapy treatment. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in radiotherapy services in Spanish hospitals. Conditions: Breakthrough Pain Intervention / Treatment: OTHER: No intervention

Inclusion Criteria: * Patients > 18 years * Cancer Patients * Patients attended in radiation oncology consultations with palliative intent * Life expectancy > 6 months * Written informed consent * Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm Exclusion Criteria: * Untreated patients with opioids for baseline pain * Patients who are not opioid tolerant * Serious psychiatric disorder or any disease or condition that prevents the collection of data * Patients with evidence of opioid addiction or history of drug or alcohol abuse

Study Objectives Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate. Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma. Conditions: Metastatic Pancreatic Adenocarcinoma Intervention / Treatment: DRUG: GEMBRAX, DRUG: FOLFIRINOX

Inclusion Criteria: * Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the radiologic data.* Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.* One or more metastatic tumors measurable metastatic lesions by CT scan of the abdomen, pelvis and chest, or hepatic MRI and CT scan (abdomen, pelvis and chest) without injection, if patient is allergic to CT contrast media).* No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.* Prior treatment with 5 FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided that at least 6 months have relapsed since completion of the last dose and no lingering toxicities are present.* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.* Males or females aged 18 to 75 years at the time of signing the Informed Consent Form (ICF).* Adequate blood function at baseline (obtained within 14 days before start of study treatment)* Adequate liver and renal function at baseline (obtained within 14 days before start of study treatment)* Patient has no clinical significant abnormalities in urinalysis results (obtained ≤ 14 days before start of study treatment)* Patient has acceptable coagulation values (obtained ≤14 days prior to the first administration of study drug)* Patient should be asymptomatic for jaundice prior to the first administration of study drug (Day1). Significant or symptomatic amounts of ascites should be drained prior to Day 1.* Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1 of treatment.* Life expectancy ≥ 2 months* Non-pregnant and non-lactating female. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β-hCG) documented 72 hours prior to randomization.* If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.* Informed consent signed prior to any study specific procedures.* Affiliated to the French National social security Exclusion Criteria: * Known brain metastases.* Patient has only locally advanced disease.* History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.* Patients having received cytotoxic doses of any other chemotherapy (than 5FU and gemcitabine) in the adjuvant setting.* Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF.* Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.* Known historical or active infection with HIV.* Major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.* History of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the SmPCs or Prescribing Information.* History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).* Patients with high cardiovascular risk, including, but not limited to, coronary stenting or myocardial infarction in the past year.* History of Peripheral Artery Disease (e.g. claudication, Leo Buerger's disease).* Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.* Enrollment in any other clinical protocol within 4 weeks of signing the ICF.* Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study.* Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to complete the study or sign the consent.

Study Objectives The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality. Conditions: Skin Cancer Intervention / Treatment: DEVICE: Nevisense 3.0, DEVICE: Dermlite Cam, PROCEDURE: Skin biopsy, DEVICE: Barco Demetra

Inclusion Criteria: * Be 18 years of age or older * Have 1-3 lesions for evaluation Exclusion Criteria: * Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear

Study Objectives To determine the safety and efficacy of administering filgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients. Conditions: Unresectable Locally Advanced NSCLC Intervention / Treatment: DRUG: Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta

Inclusion Criteria: * Histologically or cytologically confirmed NSCLC: Either histologic or cytologic proof of a newly diagnosed non-small cell lung cancer is required. A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., a second biopsy will not be required). * Patients with two or more parenchymal lesions on same or opposite sides of the lung are ineligible. * Must have unresectable Stage IIIA (N2) or IIIB disease and also satisfy the following criteria: * Unresectable Stage IIIA (N2) patients: * N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or X-ray, such that, in the opinion of the treating investigator, the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection. * N2 status must be documented by any one of the following methods: * Histologic or cytologic proof of N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Wang needle biopsy, fine needle aspiration under bronchoscopic or CT guidance or other method * Node positivity by PET scan * Nodes >2 cm on CT scan * Paralyzed left true vocal cord with separate left lung primary distinct from AP window nodes on CT Scan * Stage IIIB patients: * Pathologic documented or radiographically documented positive N3 nodes. * Patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region evidenced by one of the following: * Fine needle aspiration, core needle biopsy or excisional biopsy of supraclavicular N3 nodes * Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy * Fine needle aspiration, core needle or Wang needle biopsy under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes * Contralateral mediastinal nodes >2 cm on CT scan * Contralateral node positivity on PET scan * Right sided primary with paralyzed left true vocal cord * Any of the following T4 lesions: Tumor of any size that invades any of the following: mediastinum, heart, great vessels, trachea, esophagus, vertebral body or carina: * Written documentation of type of T4 extent by attending surgeon if the patient has had an exploratory thoracotomy or thoracoscopy * T4 involvement of the trachea or carina by direct bronchoscopic visualization * T4 involvement of the heart, esophagus, aorta, or vertebral body documented by CT scan, MRI or transesophageal ultrasound * T4 involvement of the mediastinum may also be accepted by CT or MRI criteria if, in absence of the above organ involvement, there is a soft tissue extension directly into the mediastinal space. * Radiographic criteria for involvement of main pulmonary artery or vein is allowed only if there is a mediastinal soft tissue mass. * Age > 18 years * ECOG performance status 0 or 1 * Ability to give informed consent * Adequate organ and marrow function as evidenced by the following peripheral blood counts or serum chemistries at study entry: * WBC > 4,000/µL * Absolute neutrophil count > 1,500/mm3 * Platelet count > 100 x 103 cells/mm3 * Bilirubin < 1.5 x institutional ULN * AST or ALT < 2.5 x institutional ULN * Alkaline Phosphatase <2.5 x institutional ULN * Serum Creatinine < 2.0mg/dL and/or adequate creatinine clearance * Adequate pulmonary function (FEV>1.5 liters, or if <1.5 liters, the predicted FEV1of the contralateral lung must be >800 cc based on the quantitative split function testing. (Predicted FEV1= FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report) * Must have one measurable lesion by chest X-ray or CT scan. Lesion(s) must be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or as >10mm with spiral CT scan * Men and women of childbearing potential must agree to use effective contraception while on treatment and for 6 months after treatment Exclusion Criteria: * Malignant pleural or pericardial effusion * Prior chemotherapy or radiation therapy * Pregnant or lactating females * Primary malignancy other than basal or squamous carcinoma of the skin or carcinoma in situ of the cervix, or any other cancer for which the patient has been disease free for five years. Other in situ malignancies (e.g. breast, bladder, etc) in the past 3 years are permissible * Unintentional weight loss >10% body weight within the last 3 months * Unable to provide informed consent * Any pre-malignant myeloid condition or any malignancy with myeloid characteristics * Active infection * Known hypersensitivity to E. coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product * Significant nonmalignant disease including: documented HIV infection; uncontrolled heart disease, and poorly controlled diabetes * Treatment within the last 30 days with any experimental agent

Study Objectives The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with large hepatocellular carcinoma staged BCLC A/B. Conditions: HepatoCellular Carcinoma Intervention / Treatment: PROCEDURE: Hepatic arterial infusion chemotherapy, PROCEDURE: Transarterial chemoembolization, DRUG: Folfox Protocol, DRUG: TACE Drug Protocol

Inclusion Criteria: * Age range from 18-75 years; * KPS≥70; * The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system. * Patients must have at least one tumor lesion that can be accurately measured; * The sum of diameters of all lesions longer than 10 cm with the maximum lesion longer than 7 cm. * Diagnosed as unresectable with consensus by the panel of liver surgery experts; * Re commanded treated by TAI or TACE with consensus by the panel of liver MDT; * No past history of TACE, TAI, chemotherapy or molecule-targeted treatment; * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL;(b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits;(h) Absolute neutrophil count (ANC) >1,500/mm3; * Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria: * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Evidence of bleeding diathesis. * Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug * Serious non-healing wound, ulcer, or bone fracture * Known central nervous system tumors including metastatic brain disease * Poor compliance that can not comply with the course of treatment and follow up.

Study Objectives RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at DNA in tissue samples from patients with head and neck cancer. Conditions: Head and Neck Cancer Intervention / Treatment: GENETIC: cytogenetic analysis, GENETIC: gene expression analysis, GENETIC: mutation analysis, GENETIC: polymerase chain reaction, OTHER: immunohistochemistry staining method, OTHER: laboratory biomarker analysis

Inclusion Criteria: * Patient with head and neck squamous cell carcinoma (HNSCC) enrolled in the Head and Neck Tissue Repository * Sufficient biological material collected to perform study tests * Historical material available from excess tissues at the Vanderbilt Pathology Department Exclusion Criteria: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Study Objectives The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations. Conditions: Metastatic Castration-resistant Prostate Cancer Intervention / Treatment: DRUG: olaparib, DRUG: enzalutamide, DRUG: abiraterone acetate, DRUG: abiraterone acetate, DRUG: enzalutamide

Inclusion criteria * Histologically confirmed diagnosis of prostate cancer.* Documented evidence of metastatic castration resistant prostate cancer (mCRPC).* Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .* Ongoing therapy with LHRH analog or bilateral orchiectomy.* Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).* Qualifying HRR mutation in tumor tissue. Exclusion criteria * Any previous treatment with PARP inhibitor, including olaparib.* Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization.* Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years.* Subjects with known brain metastases.

Study Objectives Determine if an oncology pictorial medication calendar will improve patient adherence to oncology supportive care medication regimens for adult patients receiving adjuvant or neo-adjuvant chemotherapy treatment for cancer. Conditions: Cancer, Chemotherapy, Medication Adherence Intervention / Treatment: DEVICE: Picture Medication Calendar

Inclusion criteria: * Outpatients 18 years or older receiving chemotherapy treatment for neoadjuvant or adjuvant solid organ cancers, * Able to provide consent for themselves, * Calendar was only available in the English language, thus fluency in English was required. Exclusion criteria: * Participants who did not attain a minimum of grade 8 education, * Significant visual impairment that precluded the ability to read the picture-based medication calendar, * Difficulty swallowing with requirement for liquid formulations of medications, * If planned to receive multiple cycles of chemotherapy at satellite oncology location instead of main study site, * If unable to repeat the instructions back to research personnel or a care provider had to speak on the participant's behalf, the participant was withdrawn from the study.

Study Objectives This phase I/II trial studies how well autologous stem cell transplant followed by donor stem cell transplant works in treating patients with lymphoma that has returned or does not respond to treatment. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). Conditions: Prolymphocytic Leukemia, Recurrent Adult Hodgkin Lymphoma, Recurrent Childhood Hodgkin Lymphoma, Recurrent Childhood Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Small Lymphocytic Lymphoma, T-Cell Chronic Lymphocytic Leukemia, T-Cell Prolymphocytic Leukemia Intervention / Treatment: PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, PROCEDURE: Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation, DRUG: Carmustine, DRUG: Cyclophosphamide, DRUG: Cyclosporine, DRUG: Cytarabine, DRUG: Etoposide, DRUG: Fludarabine Phosphate, OTHER: Laboratory Biomarker Analysis, DRUG: Melphalan, DRUG: Mycophenolate Mofetil, PROCEDURE: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation, PROCEDURE: Peripheral Blood Stem Cell Transplantation, BIOLOGICAL: Therapeutic Autologous Lymphocytes, RADIATION: Total-Body Irradiation

Inclusion Criteria: * Patients with lymphoma (non-Hodgkin lymphoma \[NHL\], chronic lymphocytic leukemia/small lymphocytic lymphoma \[CLL/SLL\] or Hodgkin's lymphoma) with primary refractory or relapsed disease after standard chemotherapy at high risk of relapse with conventional autografting; patients with a diagnosis of CLL (or small lymphocytic lymphoma) or diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or T-cell CLL or PLL * Must have an HLA genotypically or phenotypically identical related donor or, at a minimum, a high likelihood of identifying an HLA-matched unrelated donor; the determination of availability of a suitable unrelated donor may be based on a World-Book search * Cross-over to other tandem autologous-allogeneic research protocol (#2241) will be allowed if the patient loses the suitable HLA-matched related or unrelated donor but has an available HLA-haploidentical donor before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study * Cross-over from other tandem autologous-allogeneic research protocol (#2241) will be allowed if a suitable HLA-matched related or unrelated donor is identified before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study * Signed informed consent * Detectable tumor on radiographic studies or bone marrow biopsy prior to mobilization regimen * Expected survival >= 3 months from study entry * DONOR: HLA genotypically or phenotypically identical related donor * DONOR: Must consent to granulocyte-colony stimulating factor (G-CSF) (filgrastim) administration and leukapheresis for both PBSC allograft and subsequent donor lymphocyte infusion (DLI) * DONOR: Must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral or subclavian) * DONOR: Age < 75 years (yrs), older donors may be considered after review at Patient Care Conference * DONOR: Fred Hutchinson Cancer Research Center (FHCRC) matching allowed will be grades 1.0 to 2.1; unrelated donors who are prospectively: matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing * DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion * DONOR: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\*0101 and the donor is A\*0102, and this type of mismatch is not allowed * DONOR: Only G-CSF mobilized peripheral blood mononuclear cells (PBMC) only will be permitted as a hematopoietic stem cell (HSC) source on this protocol Exclusion Criteria: * Life expectancy severely limited by disease other than lymphoma * Prior autologous hematopoietic stem cell transplant * Patients at high risk of veno-occlusive disease of the liver (criteria not yet rigorously defined but includes bilirubin > 2.0 mg and serum glutamic oxaloacetic transaminase \[SGOT\] or serum glutamate pyruvate transaminase \[SGPT\] > 2 x normal); patients may be accepted outside of this range if cleared by gastrointestinal (GI) consult * Cardiac ejection fraction (EF) < 40% on multi-gated acquisition (MUGA) scan or cardiac echocardiogram (echo) (or if unable to obtain ejection fraction, shortening fraction of < 26%); patients with active or a history of cardiac disease should be evaluated with appropriate cardiac studies and/or consult; ejection fraction is required if age > 50 years or there is a history of anthracyclines or history of cardiac disease; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist * Baseline serum-creatinine > 2.0 mg/dl and a calculated or measured creatinine clearance of < 50 ml/minute * Seropositive for the human immunodeficiency virus (HIV) * Pulmonary dysfunction as measured by a corrected diffusing capacity of the lung for carbon monoxide (DLCO) < 50% of predicted total lung capacity (TLC) < 30%, forced expiratory volume in 1 second (FEV1) < 30% and/or receiving supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study must approve enrollment of all patients with pulmonary nodules * Pregnancy or breast-feeding * Patients with poorly controlled hypertension despite hypertensive medication * Karnofsky score less than 60; pediatric criteria: Lansky Play-Performance Score < 40 * Patients with cluster of differentiation (CD)34 selected auto grafts * Patients with active non-hematologic malignancies (except non-melanoma skin cancers); this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy * Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy * DONOR: Identical twin * DONOR: Age less than 12 years * DONOR: Pregnancy * DONOR: Human immunodeficiency virus (HIV) seropositivity * DONOR: Inability to achieve adequate venous access * DONOR: Known allergy to G-CSF * DONOR: Current serious systemic illness * DONOR: Failure to meet FHCRC criteria for stem cell donation * DONOR: Donor (or centers) who will exclusively donate marrow

Study Objectives This study to find out more about how patients take their anticancer medications and challenges related to taking cancer medications. Conditions: Chronic Myeloid Leukemia Intervention / Treatment:

Inclusion Criteria: * Patient is diagnosed with Chronic Myeloid Leukemia (CML) and is receiving care for CML at a participating CCDR NCORP practice, * Patient had been prescribed one of the following oral anticancer agents for CML for ≥30 days (Imatinib, Nilotinib, Dasatinib, Bosutinib, Ponatinib). Prior use of any of these medications is allowed, as long as they have been on a stable regimen for at least 30 days prior to enrollment. * Patient is 18 years of age or older Exclusion Criteria: * Patient does not speak English or requires an interpreter for medical visits * Patient is cognitively impaired, as determined by the referring provider

Study Objectives The parotid has a close relationship with the extra temporal course of the facial nerve. The study aimed to evaluate the accuracy and safety of trident landmark during superficial parotidectomy in the identification of the facial nerve trunk. Conditions: Parotid Tumor, Parotid Neoplasms, Surgery, Head and Neck Disorder Intervention / Treatment: PROCEDURE: Superficial parotidectomy

Inclusion Criteria: * patients with benign tumors of the superficial lobe of the parotid gland Exclusion Criteria: * cancers * unfit patients for surgery

Study Objectives The working hypothesis is that oral rigosertib treatment when added to platinum-based Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck Squamous Cell Carcinoma. This study will determine the highest safe dose of oral rigosertib that can be used with cisplatin and CRT. This study will also record any side effects that may occur and measure tumor sizes and how long patients live. Conditions: Head and Neck Neoplasms, Carcinoma, Squamous Cell Intervention / Treatment: DRUG: oral rigosertib, DRUG: cisplatin, RADIATION: Radiotherapy

Inclusion Criteria: * Pathologically confirmed diagnosis of Squamous Cell Carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal wall), hypopharynx, or larynx.* Patient is an appropriate candidate for definitive chemoradiotherapy.* Intermediate-risk Head and Neck Squamous Cell Carcinoma (HNSCC), defined as follows: 1. Clinical stage T2-4, N2a-N3 or T3-4, N0-N3 2. P16 (+) by immunohistochemistry (IHC) or HPV (+) by in situ hybridization (ISH) 3. Smoking status of ≥ 10 pack-years, or < 10 pack-years and T4 or N2c-N3.* If not intermediate-risk HNSCC, is high-risk HNSCC, defined as follows: 1. Clinical stage T2-4, N2a-N3 or T3-4, N0-N3. 2. P16 (-) by IHC or HPV (-) by ISH.* No evidence of distant metastases.* Clinically or radiographically evident measurable disease (as defined by RECIST v 1.1) at the primary site or nodal stations.* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.* Adequate hematologic function as defined by absolute neutrophil count (ANC) ≥ 1800/μL; platelet (PLT) ≥ 100,000/μL; Hgb ≥ 8.0 g/dL.* Adequate renal function, as defined by serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min.* Adequate liver function as defined by total bilirubin ≤ 1.5 x ULN; aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 x ULN; and prothrombin time ≤ 1.5 x ULN, unless receiving therapeutic anticoagulation.* Ability to understand the nature of the study and any hazards of study participation, to communicate satisfactorily with the Investigator, and to follow the requirements of the entire protocol.* Willingness to adhere to the prohibitions and restrictions specified in this protocol.* The patient must sign an informed consent form (ICF) indicating that s/he understands the purpose of and procedures required for the study and is willing to participate in the study. Exclusion Criteria: * Gross total excision of the primary and nodal disease.* Prior treatment with IV or oral rigosertib.* Prior chemotherapy for the study HNSCC cancer.* Prior radiotherapy to the region of the study HNSCC cancer or adjacent anatomical sites, or to > 25% of marrow-bearing area.* Synchronous malignancies.* Prior invasive malignancy unless the patient is disease-free for a minimum of 3 years; however, patients with prior non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or prostate cancer with undetectable prostate-specific antigen (PSA) may be enrolled.* Severe, active comorbidity.* Known infection with human immunodeficiency virus (HIV).* Any uncontrolled condition that, in the opinion of the Investigator, could affect the subject's participation in the study.* Major surgery within 3 weeks of enrollment or major surgery without full recovery.* Ascites requiring active medical management, including paracentesis.* Hyponatremia (defined as serum sodium < 130 milliequivalent mEq/L) or conditions that may predispose patients to hyponatremia.* Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 110 mmHg, despite treatment with 2 antihypertensive agents.* New onset of seizures within 3 months prior to enrollment, or poorly controlled seizures.* Female patients who are pregnant or lactating.* Female patients of childbearing potential and male patients with partners of childbearing potential who are unwilling to follow strict contraception requirements.* Female patients of childbearing potential who do not have a negative blood or urine pregnancy test at Screening.* History of allergic reactions attributed to compounds of similar chemical or biologic composition to rigosertib.* Prior therapy with a phosphatidyl-inositol 3 kinase (PI3K), Akt or mammalian target of rapamycin (mTOR) inhibitor.* Any other investigational agent or chemotherapy, radiotherapy, or immunotherapy within 4 weeks of enrollment.* Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures.

Study Objectives Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue. In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called qCT (quantitative computed tomography) while body composition and body fat will be measured by a different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study will also examine in depth the relationship between these three elements - Vitamin D insufficiency, obesity, and ALL - and their impact on bone density. Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Vitamin D Deficiency Intervention / Treatment: DIETARY_SUPPLEMENT: Vitamin D and Calcium Citrate

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

Study Objectives Effective treatments are desperately needed for glioblastoma (GBM) patients. This phase I clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to GBM patients shortly after completing standard-of-care treatments. Secondary outcomes will evaluate patient progression-free survival and overall survival. Conditions: Glioblastoma Intervention / Treatment: BIOLOGICAL: TH-1 Dendritic Cell Immunotherapy

Inclusion Criteria: * Provision of signed and dated informed consent form* Stated willingness to comply with all study procedures and availability for the duration of the study* Male or female, aged 18 years and older* Diagnosed with glioblastoma (GBM) deemed to be potentially resectable and who are deemed to be good candidate for postoperative adjuvant chemo and radiation therapy. This may include patients whose tumors are deemed suitable for gross total resection as well as patients whose tumors are deemed partially resectable and who undergo partial resection followed by adjuvant therapy. \[neoadjuvant therapy is rarely if ever given\]..* Ability to adhere to the bi-weekly injections of DC vaccine regimen* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 12 weeks following discontinuations of last vaccination. Must have a negative serum pregnancy test prior to first treatment.* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks following discontinuations of last vaccination.* Presented at Tumor Board for review and consensus of Multidisciplinary group to proceed with enrollment.* Adequate kidney, liver, bone marrow function, and immune function, as follows: 1. Hemoglobin ≥ 8.0 gm/dL 2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 3. Platelet count ≥ 100,000 /mm3 4. Lymphocyte count greater than 500/L 5. Glomerular filtration rate (GFR) > 60 mL/min/m2 and Creatinine < 1.5mg/dl i. For males = (140 - age\[years\]) x (body weight \[kg\]) (72) x (serum creatinine \[mg/dL\] ii. For females = 0.85 x male value f. Total bilirubin ≤ 1.5 times upper limit of normal (ULN), g. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN h. Albumin >2g/dL i. (IgM), surface antibody and antigen, Hepatitis B and C antibody. j. Negative HIV status* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Exclusion Criteria: * Locally advanced tumors deemed unresectable and/or recurrent tumors after prior vaccination.* Use of non-standard post-operative treatment regimen, as defined by the Stupp protocol: postoperative chemoradiation and initiation of temozolomide (TMZ). The use of a tumor treatment field (TTF) device with adjuvant TMZ is at the discretion of the investigator.* Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.* Patients unwilling or unable to comply with the protocol or provide informed consent.* Any severe or uncontrolled medical condition or other condition that could affect participation in this study, including but not limited to: hyper/hypothyroidism, systemic autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis.* Concurrent or expected need for therapy with corticosteroids during the vaccination phase of the study.* Treatment with another investigational drug or other intervention outside of the prespecified standard of care for GBM.* Patients suffering from active HIV disease.

Study Objectives The purpose of this study is to evaluate whether a single fraction of radiotherapy given intra-operatively and targeted to the tissues at the highest risk of local recurrence is equivalent to standard post-operative external beam radiotherapy after breast conserving surgery in women with early stage breast cancer in terms of local relapse within the treated breast. Conditions: Invasive Breast Cancer, Breast Cancer Intervention / Treatment: DEVICE: Intrabeam, RADIATION: Post-operative radiotherapy

Inclusion criteria * Age 45 years or older * Operable invasive breast cancer (T1 and small T2, N0-1, M0) confirmed by cytological or histological examination * Suitable for breast conserving surgery * Previously diagnosed and treated contralateral breast cancer may be entered but will be randomised to a separate stratum. * Available for regular follow-up for at least ten years. Note: Individual centres may wish to restrict entry to a more exactly defined subset of patients, in which case, only patients with these characteristics may be entered by that particular centre. For example, centres may decide at outset to recruit only women over 50 or even over 65 years of age. Such policies must be pre-defined in writing and approved by the International Steering Committee. Exclusion criteria * More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography or ultrasonography. * Bilateral breast cancer at the time of diagnosis. * Ipsilateral breast had a previous cancer and/or irradiation. * Patients known to have BRCA2 gene mutations, but testing for gene mutations is not required * Lobular cancer or Extensive intraductal Component (EIC =>25% of the tumour is intraductal) on core biopsy or initial pathology (if performed) * Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumour size should be excluded; those given short duration (up to 4 weeks) systemic therapy can be included. * Patients presenting with gross nodal disease, considered to be clinically malignant or proven cytologically or by scanning. In general, 4 or more positive nodes or extranodal spread are not suitable for Targit alone and should receive EBRT as well. However, individual centres may decide that anything more than micrometastasis should receive EBRT. * Patients with any severe concomitant disease that may limit their life expectancy. * Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater. * Any factor included as exclusion criterion in the local centre's Treatment Policy. This is particularly relevant to patients entered into the post pathology stratum. * No more than 30 days can have elapsed between last breast cancer surgery (not axillary) and entry into the trial for patients in the post-pathology stratification.

Study Objectives The role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy has been previously described in mice and in neuronal cell cultures (Massicot 2013); clinical manifestations and pathophysiological mechanisms potentially involved have also been described in humans (Andreas 2007) (Attal 2009). The investigators team plans to conduct a translational clinicobiological research to explain the nature of the biochemical and molecular mechanisms of the development of oxaliplatin-induced painful neuropathy. To perform this project, the investigators propose to realize a pilot study in patients newly treated with oxaliplatin. This will be conducted in the oncology department of Paris Saint Joseph Hospital from May 2014 until the inclusion of 20 patients. The main objective of this pilot study is to evaluate the occurrence of acute and chronic neuropathic pain occurring in patients newly treated with oxaliplatin. The characterization of this pain is based on validated tests (Cruccu 2010). Moreover, the biochemical changes related to oxidative stress and those related to cellular lipid composition are characterized in these patients. Conditions: Digestive Cancer, Gynecological Cancer Intervention / Treatment: DEVICE: Thermotest, DEVICE: von Frey hairs

Inclusion Criteria: * Patient newly traeted with oxaliplatin * Patient suffering from any type of cancer treated with oxaliplatin * Man or Woman over 18 Exclusion Criteria: * Patient with brain or leptomeningeal metastases * Patient previously treated with cisplatin * Patient addicted to alcohol * Diabetic patient with peripheral neurological disorders * Patient receiving calcium or magnesium salts intravenously * Patient suffering from peripheral neuropathy * Patient suffering from psychiatric disorders * Patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.

Study Objectives The present project aims at comparing two nonmyeloablative regimens currently used in 2 major HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from the Seattle group consisting of 2 Gy TBI with fludarabine (90 mg/m²) versus the one from the Stanford group combining 8 Gy TLI with ATG. Conditions: Hematological Malignancies Intervention / Treatment: DRUG: Conditioning regimen: TBI + Fludarabine, DRUG: Conditioning regimen:TLI (8 Gy) + ATG

Inclusion Criteria: PATIENT * Diseases Hematological malignancies confirmed histologically and not rapidly progressing: * AML in CR (defined as ≤ 5% marrow blasts and absence of blasts in the peripheral blood); * MDS with ≤ 5% marrow blasts and absence of blasts in the peripheral blood; * CML in CP; * MPS not in blast crisis and not with extensive marrow fibrosis, * ALL in CR; * Multiple myeloma not rapidly progressing; * CLL; * Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease); * Hodgkin's disease with chemosensitive disease.* Clinical situations * Theoretical indication for a standard allo-transplant, but not feasible because: * Age > 50 yrs; * Unacceptable end organ performance; * Patient's refusal. * Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.* Other inclusion criteria * Male or female; fertile patients must use a reliable contraception method; * Age < 75 yrs; * Informed consent given by patient or his/her guardian if of minor age. DONOR * Related to the recipient (sibling, parent or child) or unrelated; * Male or female; * Any age; * 10 of 10 (HLA-A, -B, -C, -DRB1, and -DQB1) HLA allele matched; * Weight > 15 Kg (because of leukapheresis); * Fulfills criteria for allogeneic PBSC donation according to standard procedures; * Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures. Exclusion Criteria: PATIENT * Any condition not fulfilling inclusion criteria; * HIV positive; * Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT. * Life expectancy severely limited by disease other than malignancy; * Administration of cytotoxic agent(s) for "cytoreduction" within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate); * CNS involvement with disease refractory to intrathecal chemotherapy. * Terminal organ failure, except for renal failure (dialysis acceptable) * Uncontrolled infection; * Karnofsky Performance Score <70%; * Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment; * Patient is a female who is pregnant or breastfeeding; * Previous radiation therapy precluding the use of 2 Gy TBI or 8 Gy TLI; DONOR * Any condition not fulfilling inclusion criteria; * Unable to undergo leukapheresis because of poor vein access or other reasons.

Study Objectives This study was designed to compare the efficacy, perception, decision making, and cost-effectiveness of genomic and non-genomic approaches for risk assessment of prostate cancer and for chemoprevention of prostate cancer. Conditions: Prostate Cancer, Prostate Cancer, Familial, Hereditary Prostate Cancer Intervention / Treatment: GENETIC: Genetic Risk Score: Number Format, GENETIC: Genetic Risk Score: Number + Pictograph, BEHAVIORAL: Family History: Number Format, BEHAVIORAL: Family History: Number + Pictograph

Inclusion Criteria: * age 40 to 49 years, self-defined Caucasian background, and no prior prostate specific antigen (PSA) screening nor prostate cancer (PCa) diagnosis. Exclusion Criteria: * outside of age range, or not self defined Caucasian background, or a prior history of PSA screening or PCa diagnosis

Study Objectives This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer. The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 184 patients may be enrolled in the study. Conditions: Carcinoma, Ductal, Breast, Breast Cancer Female, Breast Neoplasm, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Stage IV Breast Cancer Intervention / Treatment: DRUG: G1T48, DRUG: Palbociclib

Inclusion Criteria: * For Part 1, postmenopausal women only * For Parts 2 and 3, any menopausal status * Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapy * For Part 1, prior treatment with less than 4 prior lines of chemotherapy * For Part 2, prior treatment with less than 2 prior line of chemotherapy * For Part 3, prior treatment with no more than 1 prior line of chemotherapy * For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer * For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for metastatic breast cancer * For Parts 1 and 2, patients must satisfy 1 of the following criteria for prior therapy: * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor * Progressed after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer * For Part 3, patients must satisfy 1 of the following criteria for prior therapy: * Received ≥ 24 months of endocrine therapy in the adjuvant setting prior to recurrence or progression * Received ≥ 6 months of endocrine therapy in the advanced/metastatic setting prior to progression * For Part 1, evaluable or measurable disease * For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately 75%) as defined by RECIST, Version 1.1 including bone-only disease * ECOG performance status 0 to 1 * Adequate organ function Exclusion Criteria: * For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or SERCAs in any setting * Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease * Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy * Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow * Prior hematopoietic stem cell or bone marrow transplantation

Study Objectives The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with metastatic castration-resistant prostate cancer (mCRPC). Conditions: CRPC, Prostate Cancer Intervention / Treatment: DRUG: BIND-014

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Metastatic disease progressing despite castrate levels of testosterone * Prostate cancer progression documented by PSA * Surgically or medically castrated, with testosterone levels of < 50 ng/dL * Previous anti-androgen therapy and progression after withdrawal * ECOG performance status of 0 to 1 * Adequate organ function * Prior radiation therapy allowed to < 25% of the bone marrow * Prior hormonal therapy is allowed * Patient compliance and geographic proximity that allow adequate follow-up. * Patients with reproductive potential must use contraceptive methods * Signed informed consent from patient Exclusion Criteria: * Active infection * Any chronic medical condition requiring a high doses of corticosteroid * Pathological finding consistent with small cell carcinoma of the prostate * Brain metastasis * Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC * Radiation therapy for treatment of the primary tumor within 6 weeks * Radionuclide therapy for treatment of metastatic CRPC * Prior systemic treatment with an azole drug * Prior flutamide treatment within 4 weeks * Prior bicalutamide or nilutamide within 6 weeks * Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia * Administration of an investigational therapeutic within 2 weeks * Second primary malignancy * Presence of clinically detectable third-space fluid collections * History of severe hypersensitivity reaction to polysorbate 80 * Peripheral neuropathy at study entry

Study Objectives This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is until disease progression, and the target sample size is 43 individuals. Conditions: Carcinoma, Hepatocellular Intervention / Treatment: DRUG: Capecitabine, DRUG: Peginterferon alfa-2a

Inclusion Criteria: * Adults 18 to 75 years of age * Locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy Exclusion Criteria: * Previous treatment for liver cancer * Main portal vein involvement * Bone, brain, or leptomeningeal metastasis * Clinically significant cardiac disease * Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract * History of other cancer, except basal cell skin cancer or in situ cancer of the cervix

Study Objectives The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: BIBW 2992

Inclusion criteria: Inclusion Criteria: * Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).* Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.* Age 18 years or older.* Life expectancy of at least four (4) months.* Written informed consent that is consistent with ICH-GCP guidelines.* Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.* Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks.* Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1.* Patients must have recovered from previous surgery.* Patients must have measurable disease as defined by RECIST criteria. Exclusion criteria: Exclusion Criteria: * Active infectious disease.* Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.* Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.* Cardiac left ventricular function with resting ejection fraction <50%.* Absolute neutrophil count (ANC) less than 1500 cells/mm3.* Platelet count less than 100 000 cells/mm3.* Bilirubin greater than 1.5 mg/dl (>26 micromol /L, SI unit equivalent).* Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.* Serum creatinine greater than 1.5 mg/dl (>132 micromol/L, SI unit equivalent).* Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.* Pregnancy or breast-feeding.* Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.* Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).* Patients unable to comply with the protocol.* Active alcohol or drug abuse.* Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.

Study Objectives The study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer. Conditions: Palliative Care Intervention / Treatment: RADIATION: Short course radiotherapy

Inclusion Criteria: * histologically proven advanced pelvic cancer * excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status * age > 18 years * Eastern Cooperative Oncology Group (ECOG) <3 Exclusion Criteria: * prior radiotherapy to the same region

Study Objectives Primary diagnose HNSCC carcinoma patients eligible for curative surgery will be proposed the addition of 2 or 3 neoadjuvant cetuximab infusions. The main objective is to reduce to a minimal delay the time elapsing between last infusion and surgery. Iterative biomarkers will be taken at 6 time points permitting to investigate expression gen profile and protein mutation. Conditions: Head and Neck Cancer Intervention / Treatment: DRUG: cetuximab

Inclusion Criteria: * More than 18 years * Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx * patients selected for a primary surgical treatment * No distant metastases * No active second malignancy during the last 5 years * No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery * life expectancy more than 3 months * Not pregnant or nursing; fertile patients both male or female, must use effective contraception * Signed informed consent * Performance Status ECOG 0-1 Exclusion Criteria: * Nasopharynx cancer * Past or current malignancy other than HNSCC * performance Status ECOG above 2 * Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Use of any investigationals agents within 4 weeks prior ti entry * Previous exposure to EGFR targeting therapy * Known grade hypersensitivity to cetuximab

Study Objectives RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab. PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab. Conditions: Breast Cancer, Cardiac Toxicity Intervention / Treatment: DRUG: Coreg CR®, DRUG: lisinopril, OTHER: placebo

INCLUSION CRITERIA * Males and Females ≥ 18 years old diagnosed with HER2 positive breast cancer * Scheduled to receive neoadjuvant or adjuvant trastuzumab (Herceptin®) therapy (anthracycline-containing regimens are permitted). Patients receiving Herceptin® with their chemotherapy are permitted for eligibility work-up. Taxanes are permitted. Trastuzumab (Herceptin®) therapy may be given with or after primary chemotherapy. Pertuzumab may be used in conjunction with trastuzumab. * Left Ventricular Ejection Fraction (LVEF) ≥ 50% by MUGA scan or echocardiogram * Adequate renal function for administration of trastuzumab-containing chemotherapy regimen. * Sitting systolic blood pressure of > 90 mm Hg * Pulse ≥ 60 beats/minute * Not pregnant or breastfeeding * Female patients of childbearing potential, who are sexually active, must have a negative pregnancy test before starting the study * Both men and women must be willing to use effective contraception during the study. Teratogenicity is documented for both active study agents * Able to swallow capsules EXCLUSION CRITERIA: * Patients with metastatic disease * Prior treatment with trastuzumab or anthracyclines prior to this chemotherapy regimen * Current treatment with angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), such as losartan, β-blockers or digoxin * Known cardiac history: heart failure, myocardial infarction, radiation-induced cardiac dysfunction * Known allergy to either ACE inhibitors or β-blockers * History of bronchial asthma or related bronchospastic conditions * Hereditary or idiopathic angioedema * History of severe hypersensitivity reactions to drugs or other causes, i.e. bee stings * This protocol does not exclude patients who are participating on other investigational studies. Refer to the local IRB guidelines.

Study Objectives Erythromycin has a prokinetic effect through Motilin receptor. It evokes migrating motor complex with longer and stronger contraction. In patients with upper gastrointestinal bleeding, It has been shown that erythromycin could clear the stomach of blood, so visual examination could be improved. Frequent food stasis is encounted when we examine patients with subtotal gastrectomy. It is postulated that erythromycin reduce food stasis and help to improve endoscopy in these cases. Conditions: Subtotal Gastrectomy, Stomach Cancer Intervention / Treatment: DRUG: Erythromycin

Inclusion Criteria: * Patients who undergone STG (billroth I, billroth II, R-Y STG) within 5 years to treat gastric cancer * Stage of T1-2N0M0 Exclusion Criteria: * concomitant therapy with astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, or terfenadine, narcotics, alpha-2-adrenergic agonist, TCA, CCB, dopamine agonist, muscarinic cholinergic antagonists, octreotide, exenatide and GLP-1 agonist, phenothiazines * chemotherapy Hx. * hypersensitivity to erythromycin or any component of the product * pregnancy or lactation * comobidity : DM, AIDS, neurologic disease(parkinsonism, multiple sclerosis, brainstem stroke or tumor, diabetic or amyloid neuropathy, or primary dysautonomias) scleroderma and other connective tissue disease, recent viral enteritis history * recurrence

Study Objectives The purpose of this study is to determine whether the global and segmental hepatic uptake and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver function test results in the patients with Hepatocellular Carcinoma (HCC) before major hepatic resection or radiofrequency ablation (RFA). Conditions: Carcinoma, Hepatocellular, Liver Dysfunction Intervention / Treatment: DRUG: Gd-EOB-DTPA, DRUG: Gd-EOB-DTPA, PROCEDURE: MRI, PROCEDURE: MRI

Inclusion Criteria: * Patients with the diagnosis of HCC based on noninvasive diagnostic criteria of HCC proposed by 2010 AASLD* Surgical resection of hepatic resection greater than 2 Couinaud segments (including total hepatectomy for transplantation) or radiofrequency ablation is planned* Patients who provided the informed consent Exclusion Criteria: * Patients younger than 18 yrs old* Patients who received hepatic surgery prior to this study* Patients who underwent TACE or RFA for greater than 2 segments within 3 months prior to this study* Patients who received radiation treatment including the liver or systemic chemotherapy* Patients who underwent contrast enhanced liver MRI within 3 days prior to this study* Patients with severe renal dysfunction (Cr .2.5 mg/dL or GFR < 30mL/min)* Patients with hypersensitivity to gadolinium* Patients with uncorrectable hypokalemia* Pregnant women, or reproductive age women who will not agree with contraception during this study period.* Patients with mental disorder which will interfere with voluntary agreement* Patients who have any contraindication to MRI (cardiac pacemaker, ferromagnetic implants, etc.)* Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.

Study Objectives This study is observational study to analyze the actual overall survival of the patients who did not receive adjuvant chemotherapy after curative gastrectomy for gastric cancer. The investigators developed prediction model for the overall survival of these patients and validated. Conditions: Gastric Cancer Intervention / Treatment: OTHER: No adjuvant chemotherapy

Inclusion Criteria: * histologically confirmed primary gastric adenocarcinoma * curative R0 resection with D2 lymph node dissection * pathologic stage II or III gastric cancer Exclusion Criteria: * Patients who received neoadjuvant or AC treatment * follow-up loss or death within 30 days of surgery * completion of total gastrectomy * other malignancy within 5 years before gastrectomy

Study Objectives This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the dose expansion phase with 2 \~ 3 doses selected for expansion according to the escalation results of Part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. After the completion of dose expansion, the recommended phase II dose (RP2D) will be determined after discussion based on the obtained tolerance and PK/PD data. Conditions: Advanced Breast Cancer Intervention / Treatment: DRUG: LX-039 tablets

Inclusion Criteria: * Be able to read and sign the informed consent form.* Adult females (aged ≥18 and ≤75 years).* Be diagnosed with breast cancer confirmed by pathological examination.* Be histologically or cytologically confirmed estrogen receptor positive (ER+≥1% positive staining).* Be postmenopausal.* Subjects who have previously received endocrine therapy and obtained benefit.* ECOG(Eastern Cooperative Oncology Group) score ≤ 1.* Subjects in part2 of the study need to have measurable lesions that meet RECIST 1.1 criteria.* Has recovered from toxicity or injury from prior chemotherapy/radiotherapy .* Enough hematology and organ function.* Expected survival>3 months. Exclusion Criteria: * Subjects with HER2-overexpressing breast cancer.* Subjects with known brain metastases or other central nervous system metastases that are symptomatic or untreated.* Patients with symptomatic advanced disease who have spread to the viscera and are at risk of life-threatening complications.* Subjects who received second-line or above chemotherapy.* Subjects with known allergy to this product or any of its components.* Subjects who previously used other estrogen receptor down regulators than fulvestrant.* Subjects who received endocrine therapy or other anti-tumor agent or radiotherapy within 4 weeks prior to study entry.* Subjects who received cell therapy or tumor vaccine therapy;* Subjects with severe immunosuppression .* Severe or uncontrolled disease.* Subjects with diseases or abnormalities that may affect the administration and absorption of drugs.* Subjects with other malignancy within 5 years prior to study entry.* Subjects with other high risks of thrombosis or require long-term use of antiplatelet drugs.* Subjects with history of definite neurological or psychiatric disorders in the past.* Subjects who are HIV(human immunodeficiency virus) antibody positive, HBsAg(hepatitis B surface antigen) positive or HCV(hepatitis C virus)antibody positive.* Subjects with other uncontrolled malignant/non-malignant diseases, significant laboratory abnormalities, participation in the study may increase the risk.

Study Objectives The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU treatment in MCRC. Conditions: Colorectal Cancer, Non Resectable Metastasis, Reference Lesion, Biopsy, Thymidylate Synthase Quantitation Intervention / Treatment: DRUG: FUFA, DRUG: systemic chemotherapy

Inclusion Criteria: * patients (>= 18 years) with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy * a performance status WHO 0-2 (Karnofsky >= 60%) * an estimated life expectancy of at least 3 months * written informed consent Exclusion Criteria: * patients older than 75 years not fulfilling these criteria * brain metastases or a secondary cane * a history of a systemic palliative chemotherapy * and an adjuvant chemotherapy (within 6 months) * pregnant or nursing women * a known allergy toward irinotecanhydroclorid or of any ingredients of Campto or other severe medical * laboratory and social conditions not allowing chemotherapy and follow-up

Study Objectives The investigators propose a phase II clinical trial with the objective to investigate the potential clinical interest to associate regorafenib with a metronomic chemotherapy combining capecitabine, cyclophosphamide and low-dose aspirin, for the treatment of patients with metastatic colorectal cancer. The main objective of the study will be to achieve 15% of objective response rate in patients treated with multimodal metronomic chemotherapy and regorafenib. Conditions: Colo-rectal Cancer, Metastatic Cancer Intervention / Treatment: DRUG: Regorafenib, DRUG: Cyclophosphamide, DRUG: Capecitabine, DRUG: Aspirin

Inclusion Criteria: * Patients with histologically proven metastatic colorectal cancer in progression after previous standard treatments (5FU, CPT11, oxaliplatin, anti-VEGF and anti-EGFR therapy if KRAS and NRAS WT), or not considered as candidate for these treatments * Life expectancy of at least 3 months * Female or male with age >18 years old * Performance status = 0 or 1 (Annex 1) * Measurable disease defined according to RECIST v1.1 (scanner or MRI) (Annex 2) * Adequate bone marrow, liver and renal functions. 1. Haemoglobin ≥ 9 g/dL; absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L 2. Total serum bilirubin ≤ 1.5 times upper normal value (ULN), serum alkaline phosphatase < 5 times ULN, aminotransferases (AST/ALT) ≤ 3 × ULN in absence of hepatic metastasis or ≤ 5 if presence of hepatic lesions 3. Cockcroft glomerular filtration rate > 50 ml/min 4. Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour * Imaging target greater than one cm must be visible on CT, * No contraindication to Iodine contrast media injection during CT * For female patients of childbearing potential, negative pregnancy test within 14 days before starting the study drug. Men and women are required to use adequate birth control during the study (when applicable), * Signed and dated informed consent, * Ability to comply with the study protocol, in the Investigator's judgment. * Registration in a national health care system (CMU included). Exclusion criteria: * Diagnosis of additional malignancy within 2 years prior to the inclusion (exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical cancer), * Current participation in a study of an investigational agent or in the period of exclusion * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial ; * Patient under judicial protection (curatorship, tutorship) and/or deprived of freedom, * Planned surgical procedure within the first month of treatment or any procedure that might change the timing of regorafenib administration during the first month of treatment, * Previous exposure to regorafenib, * Previous exposure to other anti-angiogenic treatment than bevacizumab and aflibercept, * Complete deficit in dihydropyrimidine deshydrogenase (DPD), * Major surgical procedure, open biopsy or significant traumatic injury within 28 days before start of study medication, * Pregnant or breast-feeding subjects, * Congestive Heart Failure ≥ New York Heart Association (NYHA) class 2, unstable angina (anginal symptomatology at rest), * Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), * Myocardial infarction less than 6 months before start of study drug, * Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted), * Uncontrolled hypertension (Systolic blood pressure >150 mmHg and/or diastolic pressure >100 mmHg despite optimal medical management), or history of hypertensive crisis, or hypertensive encephalopathy * Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE grade 2 dyspnea), * Ongoing infection >grade 2 CTCAE V5, * Known History of human immunodeficiency virus (HIV) infection, * Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy, * Subjects with seizure disorder requiring medication, * History of organ allograft, * Subjects with evidence or history of any bleeding diathesis, irrespective of severity, * Any haemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication, * Serious, Non-healing wound, active ulcer or untreated bone fracture, * History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to inclusion, * Dehydration CTCAE v5 grade ≥1, * Known hypersensitivity to any of the study drugs, study drug classes or excipient in the formulation, * Interstitial lung disease with ongoing signs or symptoms, * Persistent proteinuria of CTCAE Grade 3 (>3.5 g/24 hours), * Subject unable to swallow oral medications, * Any malabsorption condition, unresolved toxicity higher than CTCAE (V5) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neuropathy ≤ Grade 2, * Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 3 weeks, * Treatment with any other investigational medicinal product within 28 days prior to study entry, EXCEPT for ASPIRIN, * Co-administration of drugs potentially interacting with regorafenib i.e. CYP3A4, CYP2C9 or UGT1A9 inducers/inhibitors.

Study Objectives In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to 35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin + paclitaxel or carboplatin + pemetrexed for 4 to 6 21-day cycles). Participants in the platinum-based chemotherapy arms with non-squamous tumor histologies may receive pemetrexed maintenance therapy after the 4 to 6 cycles of chemotherapy. The primary study hypothesis is that pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: BIOLOGICAL: pembrolizumab, DRUG: carboplatin, DRUG: paclitaxel, DRUG: pemetrexed

Inclusion criteria: * Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSCLC * PD-L1 positive tumor * Measureable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Life expectancy of at least 3 months * No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate organ function * No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy * Submission of formalin-fixed diagnostic tumor tissue (in the case of participants having received adjuvant systemic therapy, the tissue should be taken after completion of this therapy) * Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use two adequate barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapeutic agents used in the study * Male participants with a female partner(s) of child-bearing potential must be willing to use two adequate barrier methods of contraception from screening through 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapeutic agents used in the study Exclusion criteria: * Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or is echinoderm microtubule-associated protein-like 4(EML4) gene/anaplastic lymphoma kinase (ALK) gene fusion positive * Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy * No tumor specimen evaluable for PD-L1 expression by the central study laboratory * Squamous histology and received carboplatin in combination with paclitaxel in the adjuvant setting * Is receiving systemic steroid therapy ≤3 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication with the exception of daily steroid replacement therapy * The NSCLC can be treated with curative intent with either surgical resection and/or chemoradiation * Expected to require any other form of systemic or localized antineoplastic therapy while on study * Any prior systemic cytotoxic chemotherapy, biological therapy or major surgery within 3 weeks of the first dose of study therapy; received lung radiation therapy >30 Gy within 6 months of the first dose of study therapy * Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) * Known central nervous system metastases and/or carcinomatous meningitis * Active autoimmune disease that has required systemic treatment in the past 2 years * Had allogeneic tissue/solid organ transplantation * Interstitial lung disease or history of pneumonitis that has required oral or IV steroids * Has received or will receive a live vaccine within 30 days prior to the first study therapy (seasonal flu vaccines that do not contain live vaccine are permitted) * Active infection requiring intravenous systemic therapy * Known history of human immunodeficiency virus (HIV) * Known active Hepatitis B or C * Regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) * Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study

Study Objectives The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters. Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120. Conditions: Neoplasms Intervention / Treatment: DRUG: BIBF 1120

Inclusion Criteria: * Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120.* Age 18 years or older* Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2* Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation) Exclusion Criteria: * Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks* Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120* Active ulcers (gastro-intestinal tract, skin)* Major injuries and surgery within the past three weeks with incomplete wound healing* Hypersensitivity to BIBF 1120 or the excipients of the trial drug* Known secondary malignancy requiring therapy* Active infectious disease* Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure > NYHA II)* Gastrointestinal disorders anticipated to interfere with the resorption of the study drug* Brain metastases requiring therapy* Absolute neutrophil count less than 1,500/mm3* Platelet count less than 100,000/mm3* Bilirubin greater than 1.5 mg/dl (> 26 µmol/L)* Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)* Serum creatinine greater than 2 mg/dl (> 176 µmol/L)* Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug* Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug* Patients who are sexually active and unwilling to use a medically acceptable method of contraception* Pregnancy or lactation* Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120)* Patients unable to comply with the protocol* Active alcohol or drug abuse

Study Objectives This protocol describes procedures for the collection of blood samples for the intent of determining genetic contribution to the safety and efficacy of CPT/FU/LV. Conditions: Colorectal Neoplasms Intervention / Treatment: PROCEDURE: Blood draw

Inclusion Criteria: * Participation in studies employing treatment with irinotecan and a signed informed consent. Exclusion Criteria: * None.

Study Objectives This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes. Conditions: Pregnancy, Pregestational Diabetes, Polycystic Ovary Syndrom Intervention / Treatment: DRUG: metformin, DRUG: any drug not known as a major teratogen or major fetotoxicant

Inclusion Criteria: * Exposed group: exposed to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)). * Reference group: at no time during pregnancy were exposed to metformin, insulin or any other hypoglycaemic agent. Exclusion Criteria: * exposed to any of the following known major teratogen or major fetotoxicant: acitretin, isotretinoin, mycophenolate, thalidomide, valproic acid, angiotensin-II receptor blockers (only when used in 2nd or 3rd trimester), ACE inhibitors (only when used in 2nd or 3rd trimester), or (b) following treatment indications coded: malignancies (MedDRA code: malignant or unspecified tumors (SMQ 20000091), ICD-10: C00-D09)) or malignancy related conditions (MedDRA: SMQ 20000092), ICD-10: C00-D09). * lost to follow-up

Study Objectives To evaluate the feasibility of using Indocyanine Green in the laparoscopic surgical treatment of benign organic ovarian cysts (dermoid, serous, mucinous and endometriotic) in patients with a short-term desire for pregnancy. The use of Indocyanine Green during this surgery could allow early evaluation of the absence of alteration of the underlying ovary by the cystectomy. To do so, the fluorescence scores (indocyanine green staining) need to be compared to the ovarian reserve of the patient, previously verified intraoperatively and postoperatively at M6 and M12, these scores being determined according to the vascularization visualized in laparoscopy and established both by a double visual notation (Likert scale) and by a computer software (METAMORPH) objective notation. This procedure would, in patients with fertility disorders or wishing for pregnancy in the short run, reassure them about their reproductive potential immediately after the intervention. In the event of poor staining, if correlated by a decrease in ovarian reserve, the concerned patients could be referred to a MPA treatment facility much earlier in the postoperative period or, if no desire for immediate pregnancy, towards fertility preservation methods. Conditions: Ovarian Cysts, Endometriosis, Fertility Intervention / Treatment: DIAGNOSTIC_TEST: Use of Indocyanine Green in laparoscopic ovarian cystectomy

Inclusion Criteria: * An adult woman of childbearing potential who has a desire for short-term pregnancy, under the age of 42, to undergo laparoscopic accessible surgical treatment (<10 cm) for a benign organic ovarian cyst (serous, mucinous, dermoid or endometriotic) whose diagnosis was made on imaging (ultrasound or MRI). * Patient able to provide informed consent to her participation in the study. * Patient covered by the " Sécurité Social " insurance system. Exclusion Criteria: * Adult patient under protection, tutorship or curatorship. * Refusal of the patient or poor understanding of the French language. * Known allergy to iodine. * Current pregnancy or breastfeeding

Study Objectives Published data regarding the temporal pattern of AML are scarce and old. The greater knowledge of these neoplasias has made that their classification has been remarkable modified. Therefore, we consider relevant to carry out the present study as it would allow us to analyze the potential existence of a spatio-temporal pattern in the incidence of AML in Spain. Conditions: Acute Myeloid Leukemia Intervention / Treatment:

Inclusion Criteria Patients with a first diagnostic of AML between 2004 and 2014. .

Study Objectives This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy. Conditions: Breast Neoplasms, Osteoporosis Intervention / Treatment: DRUG: Zoledronic Acid, DRUG: Letrozole

Inclusion Criteria: * Signed informed consent* Postmenopausal status defined by one of the following : * women equal to or greater than 55 years with cessation of menses * spontaneous cessation of menses within the past 1 year, but amenorrheic in women less than or equal to 55 years (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved * bilateral oophorectomy (prior to the diagnosis of breast cancer).* Adequately diagnosed and treated breast cancer defined as: * Patients with breast cancer whose tumor can be removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery and who receive appropriate additional local treatments such as radiotherapy according to best practice. * Patients must be at the end of their local treatment without evidence of local residual disease. * Patients must have no clinical or radiological evidence of distant metastasis.* Hormone receptor positive defined as: * ER and/or PR greater than or equal to1 0 fmol/mg cytosol protein; or greater than or equal to 10% of the tumor cells positive by * immunohistochemical evaluation.* Patients with a baseline lumbar spine and total hip BMD T-score at or above -2.0 SD are eligible.* Patients who will receive adjuvant chemotherapy are eligible for participation. Adjuvant chemotherapy must be completed prior to randomization.* The date of randomization must not be more than the following: * 12 weeks from completion of surgery; * 12 weeks after completion of adjuvant chemotherapy; * 12 weeks after completion of surgery and radiation therapy; however the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion. * 12 weeks after completion of chemotherapy and radiation therapy; however, the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.* Patients who have undergone neoadjuvant chemotherapy are eligible.* No prior treatment with Femara. Exclusion criteria: * Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization.* Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.* Patients with a history of fracture with low-intensity or no associated trauma.* Patients who have started adjuvant hormonal therapy or who have completed adjuvant hormonal therapy prior to randomization.* Patients who have received any endocrine therapy within the past 12 months (other than neoadjuvant tamoxifen or toremifene, insulin and/or oral anti-diabetic medications, and thyroid hormone replacement). Hormone replacement therapy must be discontinued prior to randomization.* Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months.* Patients currently receiving oral bisphosphonates. Oral bisphosphonates must be discontinued within 3 weeks of baseline evaluations.* Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting, is acceptable).* Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months.* Patients with prior use of Tibolone within the last 6 months.* Any prior use of PTH for more than 1 week.* Prior use of systemic sodium fluoride for > 3 months during the past 2 years.* Patients currently treated with any drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to randomization.* Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for five years.* Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. Patients with a known history of HIV are excluded.* Uncontrolled seizure disorders associated with falls.* Patients with abnormal renal function as evidenced by a serum creatinine equal to or greater than 3 mg/dL (265.2 mmol/L).* History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within 12 months prior to study entry.* Patients with baseline lumber spine or total hip BMD T-score below -2.0 SD.* Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days. Additional Exclusion Criteria: (for Spine DXA) * History of surgery at the lumbosacral spine, with or without implantable devices. * Scoliosis with a Cobb angle >15 degree at the lumbar spine. * Immobility, hyperostosis or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan. * Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA. Additional protocol-defined inclusion/exclusion criteria may apply.

Study Objectives This single-center, cross-sectional survey and sensory examination is conducted to determine the prevalence, sensory characteristics and risk factors of PPSP in patients who underwent cystectomy at Washington University/Barnes-Jewish Hospital between 2009 and 2015. Based on data from other lower abdominal surgeries, the investigators hypothesize that 10-15% of patients undergoing cystectomy will develop PPSP. Conditions: Pain, Surgery, Post Operative Pain Intervention / Treatment:

Inclusion Criteria: * Age greater than or equal to 18; * Cystectomy for bladder cancer performed at Washington University/Barnes-Jewish Hospital between Jan 1, 2009 and June 30, 2015. Exclusion Criteria: Surveys will not be sent if any of the following criteria exist: * Patient is deceased or has moved out of the United States. * Preoperative record indicates multiple surgeries in the abdominopelvic region.

Study Objectives Preoperative identification of patients with pathologic complete response or residual disease in axilla can aid in tailoring subsequent axillary surgery including omission of axillary surgery based on tumor biology and response to neoadjuvant chemotherapy. Conditions: Breast Cancer Intervention / Treatment: DIAGNOSTIC_TEST: Ultrasound-guided core needle biopsy in breast

Inclusion Criteria: * Clinical stage T1-4 N1-3M0 breast cancer at diagnosis (prior to neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition* Aged above 18 and below 70 years* No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix* Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry \[IHC\] and/or in situ hybridization \[ISH\]) evaluated on core needle biopsy prior to starting neoadjuvant chemotherapy* Completing all planned cycles and regimens of neoadjuvant chemotherapy followed by axillary surgery Exclusion Criteria: * Nonrepresentative core needle biopsy in the breast during neoadjuvant chemotherapy* Inflammatory breast cancer

Study Objectives To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan. Conditions: Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst, Walled Off Necrosis Infection, Walled Off Necrosis Intervention / Treatment: DEVICE: EUS-guided fistulization AXIOS

Inclusion Criteria: * Patient who received implant procedure using study device at Japanese site. Exclusion Criteria: * NA

Study Objectives This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study. Conditions: Gastric Cancer, COVID-19 Pandemic, Peritoneal Metastases Intervention / Treatment: PROCEDURE: staging laparoscopy

Inclusion Criteria: All patients became candidates to undergo staging laparoscopy (SL) in order to investigate local and peritoneal invasion of the tumor based on National Comprehensive Cancer Network guideline for gastric cancer 2020. Exclusion Criteria: Patients with following criteria were excluded from the study; radiological evidence of metastatic disease, current or previous history of chemotherapy.

Study Objectives This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer. Conditions: Metastases, Cancer Intervention / Treatment: DRUG: ALIMTA, DRUG: folic acid, DRUG: multi-vitamins

Inclusion Criteria: * Histologic or cytologic diagnosis of metastatic or locally advanced cancer * Prior chemotherapy is allowed * Adequate bone marrow, liver and kidney function Exclusion Criteria: * Prior treatment with ALIMTA * Brain metastasis * Pregnancy or breast feeding

Study Objectives Assess whether the combination of ABT-888 with temozolomide (TMZ) has activity in subjects with metastatic castration resistant prostate cancer (CRPC) as reflected by the prostate-specific antigen (PSA) response. Conditions: Prostate Cancer Intervention / Treatment: DRUG: ABT-888, DRUG: temozolomide

Inclusion Criteria: * Subject has histologically or cytologically confirmed prostate cancer. * Metastatic prostate cancer with measurable and/or bony disease that has progressed despite androgen deprivation therapy and at least one and no more than two prior systemic non hormonal therapies (at least one must include docetaxel) for castration resistant metastatic disease. * At least 28 days must have elapsed since completion of prior anti-cancer therapy and must have recovered from all side effects to < Grade 1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. ECOG PS 3 is allowed if due to pain. * Subjects must have PSA progression defined as: * A 25% increase in PSA over a baseline value with an increase in the absolute value of PSA level by 2 ng/ml, that is confirmed by another PSA level at a minimum of 1 week interval. * Subjects must have a minimum PSA of > 2 ng/ml. * Testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue if they have not undergone orchiectomy. * No investigational or commercial agents (other than LHRH analogue) or therapies including other hormonal agents such as antiandrogens or herbal medications may be administered with the intent to treat the subject's malignancy. Subjects on stable doses of steroids or megestrol acetate (for hot flashes or appetite) are allowed. * Four weeks must have elapsed since major surgery. * Prior radiotherapy is allowed as long as the bone marrow function is adequate and at least 4 weeks has elapsed since completion of radiation therapy. No prior radiopharmaceuticals are allowed. * Subjects must have normal organ and bone marrow function as defined below obtained within two weeks from treatment initiation: * Bone Marrow: absolute neutrophil count ≥ 1,500/mcL; platelets ≥ 100,000/mcL; hemoglobin ≥ 9.0 g/dL * Renal function: Serum creatinine ≤ 1.5 × upper limits of institution's normal (ULIN) range or creatinine clearance ≥ 50 mL/min/1.73 m2 * Hepatic Function: Aspartate aminotransferase (AST) and/or alanine transaminase (ALT) ≤ 2.5 × ULIN. For subjects with liver metastases, AST and/or ALT < 5 × ULIN. Bilirubin ≤ 1.5 × ULIN (Subjects with Gilbert's Syndrome may have a bilirubin ≥ 1.5 × ULIN) * Subjects who refuse to provide blood samples for the correlative studies will be eligible. * ABT-888 and temozolomide are known to be teratogenic, therefore 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. * Subjects with treated and controlled epidural disease are permitted into the study. * Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures. Exclusion Criteria: * A subject with cord compression or a history of uncontrolled central nervous system (CNS) metastases or leptomeningeal disease. * Subject has had prior therapies with Dacarbazine (DTIC) or TMZ containing regimens. * The subject has received an investigational agent within 28 days prior to study drug administration. * Subject with a history of seizure disorder and currently receiving medications for seizure disorders (e.g., steroid or anticonvulsant drugs). * The subject has had another active malignancy within the past 1 year with the exception of definitely treated carcinomas in situ, superficial bladder cancer, and non-melanoma carcinoma of the skin. Questions regarding inclusion of individual subjects should be discussed with the Abbott Medical Monitor. * Clinically significant and uncontrolled major medical condition(s) including but not limited to: * active uncontrolled infection, * symptomatic congestive heart failure, * unstable angina pectoris or cardiac arrhythmia, * Psychiatric illness/social situation that would limit compliance with study requirements, * Or any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities. * Subject has previously been treated with a PARP inhibitor.

Study Objectives This is a multi-centre, phase II, open-label, 12-month clinical trial for patients previously treated with WST09 (Tookad) who have positive prostate biopsies for cancer. The study aims at delivering a second WST09 treatment for the purpose of eradicating the localized prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Treatment with Tookad VTP, DRUG: Treatment with Tookad VTP, DRUG: Treatment with Tookad VTP

Inclusion Criteria: * Patients previously treated with WST09-mediated VTP, with a positive biopsy of the prostate 6 months following treatment * Disease confined to the prostate * Life expectancy greater than 5 years Exclusion Criteria: * Unwilling or unable to give informed consent * Patients who have received another treatment for their prostate cancer since their previous WST09-mediated VTP