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Study Objectives The purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at RedPATH. In some patients additional brushings will be obtained for FISH testing (this adds \<2 minutes to ERCP and only associated risk is increased procedure duration). The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity and accuracy when compared to cytology +FISH in patients with biliary strictures. Primary aim: To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. Secondary aims: 1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used. 2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis. Conditions: Bile Duct Stricture, Cholangiocarcinoma, Pancreatic Cancer, Chronic Pancreatitis Intervention / Treatment: OTHER: brushing of bile duct strictures for cytology Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients age: > 18 years * Presence of a biliary stricture * Ability to provide written informed consent. Exclusion Criteria: * Severe coagulopathy (INR > 1.8) or thrombocytopenia (platelet count <50,000) * Inability to cannulate the common bile duct * Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)

Study Objectives To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously to Japanese patients with acute myeloid leukemia (AML). Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: SGI-110 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: FACTORIAL Masking: NONE

Inclusion Criteria: * Male or female patients with a diagnosis of AML (WHO classification 2008). * Patients, 20 years of age or older, who are unresponsive to standard chemotherapy or have relapsed following standard chemotherapy * Patients, 65 years of age or older, who are not eligible for standard intensive chemotherapy * Patients with ECOG performance status (PS) of 0 to 2 * Patients with adequate organ function * Women of child-bearing potential must not be pregnant or breast feeding (pregnancy test will be performed at Screening). Women of child bearing potential and all men with female partners of child bearing potential must practice two medically acceptable methods of birth control and must not become pregnant or father a child while receiving treatment with SGI-110 and for 3 months following last dosing. * Patients who have undergone prior allogeneic hematopoietic stem cell transplantation must have no evidence of active graft-versus host disease (GVHD) and must be off immunosuppressive therapy by ≥2 weeks prior to IMP administration. Exclusion Criteria: * Patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or (PML/RARA) karyotype abnormalities (include other variant types of APL) * Patients with multiple cancers (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 3 years) * Subjects with life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk. * Patients with poorly controlled arrhythmias, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification * Patients with symptomatic central nervous system involvement.

Study Objectives Barrett's oesophagus is a condition where the lining of the oesophagus (gullet) wall changes. People with Barrett's oesophagus are at risk of developing oesophageal cancer but can have regular checkups to detect changes before they progress to cancer. Every two years patients with Barrett's are offered examination by passing a fibreoptic tube into the oesophagus (gastroscopy) to remove small tissue samples (biopsies), which are examined in the laboratory to check for changes. Bowel cancer is the third most common cancer in the UK, and the second leading cause of cancer deaths. Prevention and early detection are the most effective strategies of dealing with bowel cancer. Most cancers develop from benign polyps (growths) in the bowel. Polyps are common and have the potential of developing into cancer over the course of many years. Patients with a prior diagnosis of Barrett's oesophagus and colonic polyps undergo regular endoscopic examinations known as surveillance endoscopies. This is done to detect changes in the cells of Barrett's oesophagus or further polyps. Current practice is to capture recorded videos of Barrett's surveillance examinations and still images of polyps prior to their removal. Endoscope technology continues to advance. These newly developed technologies are marketed to have claims of superiority in performance over preceding generations often without the back up of scientific data but at a significant financial cost. The aim of this study is to use endoscopic images and videos recorded as part of routine clinical practice to compare the current version of Olympus endoscopes with the new version launched by the company. Conditions: Barrett Esophagus, Polyps Intervention / Treatment: DEVICE: Olympus Elite, DEVICE: Olympus Spectrum Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Patients attending for Barrett's surveillance OR * Patients attending for colonic polyp surveillance or screening * Patients are willing and able to give informed consent. Exclusion Criteria: * Polyp syndromes (eg FAP or Lynch Syndrome) * Known history of IBD

Study Objectives Clinical study of HEC68498 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of HEC68498 in patients with advanced refractory solid tumors Conditions: Advanced Refractory Solid Tumors Intervention / Treatment: DRUG: HEC68498 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: （1）Target subjects * 18 years of age ≤ age ≤ 70 years of age, regardless of gender; * Patients with various types of advanced solid tumors confirmed by cytological or histological examination. Dose escalation test phase: including breast cancer, colorectal cancer, neuroendocrine tumors, etc .; Extended trial phase: limited to patients with HR + / HER2-, triple-negative, breast, colorectal, and neuroendocrine tumors, and patients with HR + / HER2- and colorectal cancer need genetic testing (blood and / or tumor tissue) PIK3CA mutations have been confirmed. Patients with triple negative breast cancer need genetic testing (blood and / or tumor tissue) to confirm PIK3CA / PTEN- mutations. * Requires at least standard treatment failure or no standard treatment. Definition of treatment failure: a. Disease progression during or after treatment must have clear imaging or clinical evidence; b. Withdrawal from treatment due to intolerable response. * According to the solid tumor evaluation criteria (RECIST 1.1), there is at least one measurable lesion. * Relieve from previous chemotherapy, hormone therapy, targeted therapy, radiotherapy or surgical treatment of toxic reactions (according to CTCAE v5.0 grading ≤ 1 except hair loss) * ECOG score is 0 or 1 (see Annex 2 for ECOG score criteria); * Expected survival time ≥ 12 weeks; (2) The subject must have proper organ function * Blood routine: absolute neutrophil (ANC) ≥ 1.5 × 109 / L; platelet (PLT) ≥ 75 × 109 / L; hemoglobin (Hb) ≥ 90 g / L; Have received hematopoietic cell colony-stimulating growth factors (eg G-CSF, GM-CSF) or have not received blood transfusions. Erythropoietin or erythropoietin therapy can be maintained if it is used immediately before enrollment. * Liver function: ALT and AST ≤ 2.5 × ULN (for patients with liver metastases, ALT and AST can be relaxed to ≤ 5.0 × ULN); serum bilirubin ≤ 1.5 × ULN; * Renal function: serum creatinine ≤ 1.5 × ULN; or creatinine clearance (CrCl) ≥ 60 mL / min calculated according to the Cockcroft-Gault formula: Urine routine urinary protein ≤ 1+; if urinary routine urinary protein ≥ 2+, a 24-hour urine protein quantification is less than 1 g. * Electrolyte: LLN ≤ blood potassium ≤ ULN; * Coagulation function: international standardized ratio (INR) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) ≤ 1.5 × ULN; Exclusion Criteria: (1) previous treatment history * Have previously been treated with PI3K inhibitors, mTOR inhibitors (such as everolimus) or AKT inhibitors. * Patients who have received targeted therapy within 4 weeks before the first dose or ≤ 5 × drug half-life (if the half-life of the drug is specified, it is calculated as 5 times the half-life, otherwise 4 weeks); * Patients who have received chemotherapy, hormonal antitumor therapy, immunotherapy or major surgery within 4 weeks before the first dose. Note: If the previous treatment was nitrosourea or mitomycin, the treatment must be discontinued at least 6 weeks before the first study drug is administered. * Patients who have received radiation therapy within 4 weeks before the first dose. * Have received clinical trial drug treatment within 4 weeks before the first medication, or are receiving other clinical trial drug treatment; (2) History of disease and surgery * CNS metastases requiring current treatment or uncontrolled CNS metastases; or CNS metastases confirmed but not stable for more than 4 weeks after treatment; * Patients with spinal cord compression, cancerous meningitis, or meningitis; * Currently diagnosed with type I or type II diabetes or fasting blood glucose levels> 6.7 mmol / L, or HbA1c> 7%; * Patients with hypertension controlled by two or more drugs, or uncontrolled hypertension (systolic blood pressure> 140 mmHg or diastolic blood pressure> 90 mmHg); * Left ventricular ejection fraction (LVEF) <50%; QTcF> 450 ms for men, QTcF> 470 ms for women (QTcF is calculated using Fridericia's correction formula QTcF = QT / RR 0.33); any room with obvious clinical significance History of arrhythmia (such as ventricular tachycardia, ventricular fibrillation, torsional ventricular tachycardia or frequent ventricular premature beats, congenital prolonged QT interval syndrome). * Multiple factors affecting oral medication (eg, inability to swallow, chronic diarrhea, and intestinal obstruction, etc.); * Patients with a clear tendency to gastrointestinal bleeding, including the following: local active ulcer lesions and positive fecal occult blood; those with a history of melena and vomiting within 2 months before the first medication; researchers believe that digestion may occur Major bleeding

Study Objectives This study aims to develop a cost-effective screening strategy for the Singapore population by targeted screening of people who have a high risk of stomach cancer, in order to detect early signs of the disease at a stage that can be prevented or cured. Often, patients only consult their doctors when they have advanced symptoms, by which time the cancer may be at a difficult to treat, or incurable stage. Using costs in the Singapore health system as well as local population risk profiles and demographics, our previous study demonstrated that screening of high-risk groups is cost-effective and a panel of serum makers was effective in differentiating high-risk from low-risk individuals. This study aims to validate the predictive value of various blood biomarkers, such as that of antibodies against Helicobacter pylori, pepsinogen levels, micro RNAs (miRNAs) and blood-based protein markers in participants who have been scheduled to undergo upper gastrointestinal (GI) endoscopy for clinical reasons. If successful, the marker can be used to stratify population into different risk groups and various screening systems can be provided according to different risk level. This will reduce the number of annual invasive screening examinations required to detect early gastric cancer (GC), thereby rendering it cost-effective to generalize as clinical practice in Singapore. Conditions: Stomach Neoplasm Intervention / Treatment: DIAGNOSTIC_TEST: blood-based biomarkers analyses Location: Singapore Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * The subject is greater than 40 years of age. * The subject is scheduled to undergo an endoscopy because of medical indication. * The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study. * The subject must be willing and able to comply with all study procedures. Exclusion Criteria: * The subject who is unable to undergo gastroscopy. * The subject with previous total or partial gastrectomy. * The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study. * The subject is unwilling or unable to provide signed informed consent. * The subject who is pregnant.

Study Objectives This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast cancer (mBC) that has spread to the brain and does not respond to treatment. Pegylated irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Stage IV Non-small Cell Lung Cancer (NSCLC), Recurrent Non-small Cell Lung Cancer (NSCLC), Extensive-stage Small Cell Lung Cancer (SCLC), Recurrent Small Cell Lung Cancer (SCLC), Tumors Metastatic to Brain, Metastatic Breast Cancer (mBC) Intervention / Treatment: DRUG: Pegylated Irinotecan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * At least 18 years of age. * Life expectancy of 3 months or longer. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Advanced or refractory cancer, consisting of * Metastatic breast cancer (mBC) for which single-agent cytotoxic chemotherapy is indicated. OR * Histologically-proven metastatic lung cancer: * Non-small cell lung cancer (NSCLC) as Stage IV disease or recurrent metastatic disease \[per lung cancer tumor, node and metastasis (TNM) classification system, 7th ed\] (Cohort A) OR * Small cell lung cancer (SCLC) as extensive stage or recurrent metastatic disease (cohort B), including tumors with mixed small cell and non-small cell elements. Prior chemotherapy (at least one of the following): * At least one line of prior systemic chemotherapy * At least one line of prior targeted treatment for metastatic disease Adjuvant systemic chemotherapy within prior 6 months Prior treatment for metastatic breast cancer (mBC) must have included taxane-based regimen Prior chemotherapy, including other investigational therapy, has been completed prior to initiation of study treatment, according to the following: * ≥ 2 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered on a daily or weekly schedule * ≥ 3 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 2 weeks * ≥ 4 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 3 weeks Previously received at least one CNS directed treatment (such as surgery or radiation) OR not be eligible for CNS stereotactic radiosurgery Measurable CNS disease, either previously untreated (not counting systemic therapy), or progressed following previous radiation treatment. Lesions that have progressed after prior radiosurgery should not be selected as measurable disease if they are suspected of being radionecrosis. The following measurement criteria are required, as visualized by contrast-enhanced MRI with slice thickness of ≤ 1.5 mm, unless absence of contrast or thicker slices is specifically authorized by Protocol Director. Measurements do not include tumor edema. * At least one CNS tumor measuring ≥ 10 mm in longest diameter, OR * At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm. Additional tumors are not exclusionary. Adequate organ function as evidenced by: * Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L without G-CSF (filgrastim, pegfilgrastim, or equivalent) support within 7 days * Hemoglobin (Hgb) ≥ 9.0 g/dL (90 g/L) without blood transfusion within 7 days * Platelet count ≥ 100 x 10e9/L without platelet transfusion within 7 days * Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with documented history of Gilbert's disease who may have DIRECT bilirubin ≤ 1.5 X ULN * Alanine aminotransferase (ALT) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases * Aspartate aminotransferase (AST) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases * Serum creatinine ≤ 1.5 X ULN; or calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula), or measured creatinine clearance ≥ 50 mL/min. Exclusion Criteria: * Previous treatment with a camptothecin derivative (eg, irinotecan, topotecan, and investigational agents including but not limited to exatecan, rubitecan, gimatecan, karenitecin, SN38 investigational agents, EZN 2208, SN 2310, and AR 67) is not allowed * Patients may not have a known history of leptomeningeal disease, as diagnosed by positive CSF cytology, unless prospective permission for enrollment is granted from the sponsor and the PI * Patients may not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period * Patients may not have the following co morbid disease or concurrent illness: * Chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients may not use chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to first dose of investigational drug. (exception: anti-diarrheal medications used to control symptoms from a medication that will be discontinued prior to study are allowed with a 7 day washout before study therapy, for example loperamide for erlotinib-associated diarrhea) * Known cirrhosis, defined as Child Pugh class A or higher liver disease * Other active malignancy, except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder) * Any other severe/uncontrolled inter current illness or significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation * Patients may not have a known allergy or hypersensitivity to any of the components of the investigational therapy, including polyethylene glycol (PEG) or topoisomerase inhibitors * Patients may not be receiving the following medications at the time of first dose of investigational drug: * Pharmacotherapy for known hepatitis B or C, tuberculosis, or human immunodeficiency virus (HIV) * Any of the following enzyme inducing anti epileptic medications (EIAEDs): phenytoin, carbamazepine, oxcarbazepine, phenobarbital * Other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except for bisphosphonates or denosumab * Pregnant or nursing patients will be excluded from the study

Study Objectives D2 gastrectomy is standard treatment of early gastric cancer in Japan but in other countries there is still some discord, especially in Europe and North America. Although the quantity of metastasis cancer in lymph node defines survival regardless of which country the patient is treated, the total number of lymph nodes harvested is an important factor to predict accurate staging and/or D2 gastrectomy. Both of the number total lymph nodes and the metastasis lymph node status in gastric cancer are important factors to decide each prognosis. This study evaluated the correlation between total lymph nodes retrieved and metastasis node by lymph node ratio (LNR) status to determine the recurrence rate after curative resection of gastric Conditions: Gastric Cancer Location: Thailand Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Gastric cancer after curative surgery resection * No received neoadjuvant therapy * Patients have tissues confirmed by Pathology * Staging used esophagogastroduodenoscopy (EGD) or imaging, including ultrasonography, Computer Tomography (CT) or Magnetic Resonance Imaging (MRI * Surgery was performed for curative intent and D2 lymphadenectomy and according from Japanese guideline for gastric cancer Exclusion Criteria: * Distant metastasis during surgery

Study Objectives Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL). Conditions: Marginal Zone Lymphoma Intervention / Treatment: DRUG: Rituximab, DRUG: Ibritumomab Tiuxetan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months) * Measurable and evaluable disease * All stages are eligible * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B) * Willing and able to provide written informed consent * Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment * Life expectancy of at least 6 months Exclusion Criteria: * Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment. * ≥ 25% lymphoma bone marrow involvement * Platelet count < 100,000 cells/mm³ * Neutrophil count < 1,500 cells/mm³ * Known history of HIV infection * Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) * Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection. * Physical or mental condition that makes patient unable to complete specified follow-up assessments

Study Objectives The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples. Conditions: Cervical Intraepithelial Neoplasia Grade 2/3, Neoplasm Cervix, Carcinoma in Situ, Carcinoma Cervix Uterine, Neoplasms, Neoplasms by Histologic Type Intervention / Treatment: DEVICE: Self-Collecting Devices, DIAGNOSTIC_TEST: In Vitro Diagnostic Assays Location: Ireland, Italy, United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Women referred to colposcopy evaluation for any reason \[i.e. previous history of abnormal cervical screen test results (cytology, HPV test), previous abnormal colposcopy\] * Ability to understand and sign the informed consent * Informed consent given Exclusion Criteria: * Age < 25 or > 65 years * Past history of hysterectomy * Women with known pregnancy * Pregnancy within last 3 months * Vulnerable patient: a patient who is or may be for any reason unable to take care of him or herself, or unable to protect him or herself against significant harm or exploitation * Simultaneous involvement in any other research project

Study Objectives The purpose of this study is to see if the addition of the investigation drug called pembrolizumab (Keytruda®) to radiation therapy and bevacizumab (Avastin®) is safe and can help with controlling the growth of tumors, in participants with recurrent high grade glioma. Conditions: Malignant Glioma Intervention / Treatment: RADIATION: Hypofractionated Stereotactic Irradiation (HFSRT), DRUG: Pembrolizumab, DRUG: Bevacizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed diagnosis of World Health Organization (WHO) Grade III (except anaplastic oligodendroglioma) or IV malignant glioma. * Documented recurrence by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI) performed within 28 days of entry into the trial as per Response Assessment Criteria for High-Grade Gliomas (RANO) Criteria. * Patients with recurrent WHO Grade III gliomas should have received one prior treatment for recurrent high grade disease. * Maximum diameter of enhancing tumor (target lesion) should be ≤ 3.5 cm. * Interval of ≥ 6 months after the end of prior radiation therapy is required unless there is a new recurrence outside of the previous radiotherapy treatment field. * Previous first line treatment with at least standard dose of radiotherapy (total dose ≥ 54 Gy) and temozolomide. * Interval of ≥ 4 weeks since surgical resection prior to entry into the trial. * Interval of ≥ 4 weeks after last administration of any investigational agent or prior cytotoxic therapy (except bevacizumab). There should be 14 days interval between the last dose of bevacizumab and first day of treatment on study. * Age 18 years or older on day of signing informed consent. * Karnofsky performance status ≥ 70. * Demonstrate adequate organ function. * Resting baseline O2 saturation by pulse oximetry of ≥ 92% at rest. * Must have recovered from the toxic effects of prior therapies. * Willing and able to provide written informed consent/assent for the trial. * Life expectancy ≥ 12 weeks. * Female participants of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving first dose of study medication. Must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. * Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: * More than 3 recurrences of high grade glioma. * Has anaplastic oligodendroglioma. * Has received reradiation to recurrent disease (other than standard frontline adjuvant radiation therapy). * Recurrent tumors near the brainstem and optic chiasm must not have received prior radiation therapy. * Infratentorial, or leptomeningeal evidence of recurrent disease. * Recurrent or persistent tumor (enhancing area) greater than 3.5 cm in maximum diameter. * Prior treatment with Gliadel unless it was administered as first line treatment and ≥ 3 months prior to study treatment. * Unable (due to existent medical condition) or unwilling to have a contrast enhanced MRI of brain. * Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of treatment. * Diagnosis of immunodeficiency or is receiving systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Physiologic doses of steroid therapy (≤ 10 mg/day prednisone equivalents) is allowed. * Prior chemotherapy, targeted small molecule therapy, or monoclonal antibody (except bevacizumab) within 4 weeks prior to study Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. Wash out period for bevacizumab is 14 days. * Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Active autoimmune disease requiring systemic treatment within past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents. * Evidence of interstitial lung disease or active, non-infectious pneumonitis. * Active infection requiring systemic therapy. * Prior allergic reaction to Bevacizumab. * History of uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy. * History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to entry into the trial. * History of gastrointestinal bleeding or any other hemorrhage/bleeding event ≥ grade 3 (CTCAE, v. 4) within 30 days prior to entry in to the trial. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of treatment on study. * Requires escalating or chronic supraphysiologic doses of corticosteroids (> 10 mg/day prednisone equivalents). * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Prior therapy with an anti-Programmed Death 1(PD-1), anti-Programmed Death-1 Ligand 1 (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 history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Known active Hepatitis B. * Has received a live vaccine within 30 days prior to the first dose of trial treatment.

Study Objectives The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope auxiliary imaging system. The primary objective of this study is to assess the degree to which incorporating the Third Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the detection of additional polyps. Specifically, the primary goals are to estimate (1) the proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope, and (2) the proportion of patients found under this protocol to have polyps who would have incorrectly been classified as polyp-free had the Third Eye Retroscope not been used. Conditions: Colorectal Cancer Intervention / Treatment: DEVICE: Third Eye Retroscope Auxiliary Imaging System Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The patient is undergoing colonoscopy for screening purposes or for surveillance in follow-up for previous polypectomy. * The patient is at satisfactory risk for abdominal surgery. * The patient must understand and provide written consent for the procedure. Exclusion Criteria: * Patients who are <50 years or >80 years of age * Patients who are pregnant. * Patients with history of colonic resection. * Patients requiring ongoing anticoagulation therapy. * Patients with a history of severe cardiovascular, pulmonary, liver or renal disease. * Patients with hypersensitivity to opioid analgesics. * Patients with an active systemic infection. * Patients with suspected chronic stricture potentially precluding complete colonoscopy. * Patients with major psychiatric disease (dementia, schizophrenia or depression). * Patients with diverticulitis or toxic megacolon. * Patients with history of radiation therapy to abdomen or pelvis. * Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Study Objectives This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients. Conditions: Locally Advanced Rectal Cancer Intervention / Treatment: DIAGNOSTIC_TEST: pelvic MR examination Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * pathologically proved rectal cancer * locally advanced rectal cancer (≥T3 or N+) * a distance less than 12cm between the lower edge of tumor and the anal margin * no evidence of distant metastases * no prior anti-cancer therapy before treatment * scheduled to receive preoperative CRT Exclusion Criteria: * history or concurrent of other malignancy * incomplete preoperative CRT * failed to receive surgery or unavailable pCR assessment * poor quality of MR images for measurement * patient quit

Study Objectives The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival. Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival. Conditions: Diffuse Large B Cell Lymphoma Intervention / Treatment: DRUG: Revlimid Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria:Understand and voluntarily sign an informed consent form. * Age 18 years at the time of signing the informed consent form. * Able to adhere to the study visit schedule and other protocol requirements. * Histologically confirmed diffuse large B cell lymphoma * Relapsed or refractory after one prior therapeutic treatment for DLBCL. Refractory is defined as patients received adequate prior treatment and did not respond during treatment or progressed within 90 days of last treatment. * Measurable disease with at least on bidimensional lymph node or tumor mass >1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT * Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease * Eligible for autologous stem cell transplant * All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study. * Eastern Cooperative Oncology Group (ECOG) performance status of 2 at study entry (see Appendix B). * Laboratory test results within these ranges: * Absolute neutrophil count >1000 /mm³ * Platelet count > 50,000/mm³ (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Calculated creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula (Appendix E) for patients enrolled into the phase I portion of the study (Stage I). Calculated creatinine clearance of ≥ 30 mL/min by Cockroft-Gault formula for patients enrolled into the phase II portion of the study (Stage II). See Section 5.4.2 for lenalidomide dose adjustment for calculated creatinine clearance > 30ml/min and < 60ml/min. * Total bilirubin < 1.5 x Upper Limit of Normal (ULN). * Aspartate Aminotransferase (SGOT) and Alanine Aminotransferase (SGPT) < 3 x ULN. * Disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast. * All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. * Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. * Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin). - Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities. * Use of any other experimental drug or therapy within 28 days of baseline. * Known hypersensitivity to thalidomide. * The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * Concurrent use of other nonprotocol anti-cancer agents or treatments. * Known positive for HIV or active infectious hepatitis, type B or C. * Refusal of autologous stem cell transplant. * Patients with active central nervous system involvement based on clinical evaluation. Previously treated central nervous system (CNS) involvement that has remained asymptomatic for more than ninety days is allowed if no active CNS disease present as confirmed by MRI or/and lumbar puncture. * Concurrent uncontrolled serious medical ort psychiatric conditions likely to interfere with participation in this clinical study, as judged by investigator. * Prior Lenalidomide exposure for more than 28 days. -

Study Objectives The study is designed to measure salivary matrix metalloproteinase-1 (MMP-1) using the enzyme-linked immunosorbent assay (ELISA) we developed previously in patients with oral potentially malignant disorders (OPMD), oral squamous cell carcinoma (OSCC), and healthy participants. The purpose of this study is to evaluate the potential of the newly developed salivary MMP-1 ELISA as an adjunctive tool to aid in diagnosis of OSCC. Conditions: Oral Squamous Cell Carcinoma Intervention / Treatment: DIAGNOSTIC_TEST: MMP-1 Enzyme Linked Immunosorbent assay (ELISA) Location: Taiwan Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Group OSCC: patients with lesions of OSCC * Group OPMD: patients with lesions of OPMD * Group HC: healthy subjects who are not suffering from any oral lesions and having behaviors of smoking, and/or betel nut chewing Exclusion Criteria: * Subjects having personal history of other cancers or severe diseases

Study Objectives Primary Objective: * Developing Common Toxicity Criteria (CTC) 3.0 grade \> 3 treatment related pneumonitis (TRP) or * Developing local-regional recurrence among patients treated with 3D conformal radiation therapy (CRT) (Arm 1) or intensity modulated radiation therapy (IMRT) (Arm 2). Secondary Objectives: * To assess and compare the time to develop CTC 3.0 grade \> 3 radiation esophagitis in patients with non-small cell lung cancer (NSCLC) treated in arm 1 and arm 2. * To investigate the association of inflammatory cytokines with the time to the development of radiation pneumonitis and outcomes to concurrent chemoradiation between arm 1 and arm 2. * To investigate the association of relevant pharmacogenetics, biomarkers, and gene polymorphisms with the time to the development of radiation pneumonitis and treatment outcomes to concurrent chemoradiation between arm 1 and arm 2. * To evaluate image guided adaptive radiation therapy (IGART) using weekly computed tomography (CT) on rail or cone beam CT in the assessment of tumor response and impact on treatment planning and delivery. * To compare overall survival, progression-free survival, median survival time, in arm 1 and arm 2. * To evaluate the role of functional image of fluorodeoxyglucose-positron emission tomography (FDG-PET) in assessing and predicting the time to the development of TRP and tumor response. * To measure and compare symptom burden over time of the treatment using MD Anderson Symptom Inventory (MDASI)-Lung in the 2 arms. * To determine the impact of comorbid conditions on survival. Conditions: Lung Cancer Intervention / Treatment: PROCEDURE: Intensity Modulated Radiation Therapy, PROCEDURE: 3-Dimensional Conformal Radiation Therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pathologically proven diagnosis of unresected loco-regionally advanced non-small cell lung cancer without evidence of hematogenous metastases, Stages IIB-IIIB without contralateral hilar nodal disease. * Patient is suitable for concurrent chemoradiation therapy per treating physician's assessment (kps >= 70, weight loss < 10% in three months prior to diagnosis). * Patients with Stage IV NSCLC with solitary metastasis (brain, one side of adrenal gland, or one site of bone), who have clinical indication of concurrent chemoradiation to the primary disease in the lung are eligible. * Patients who received induction chemotherapy and then referred for concurrent chemoradiation are eligible. * Patients who had local regional recurrence after surgical resection and who are suitable for definitive concurrent chemoradiation are eligible. * Measurable disease by chest x-ray and/or contrast-enhanced CT, and/or PET scan * FEV 1> 1000 cc * Pre-chemoradiation FDG-PET within 10 weeks prior to randomization. This PET/CT is a standard procedure for staging. It is strongly encouraged to have this PET/CT performed at the same time for 4-D CT simulation using the 4-D PET/CT scanner at the department of radiation oncology. * Patient will undergo routine standard pretreatment evaluations as decided by treating physician, which usually include magnetic resonance imaging (MRI) or CT of the brain, contrast CT scan of the thorax and upper abdomen, pulmonary functional test, single-photon emission computerized tomography (SPECT), liver function tests (LFT), blood chemistry, renal functional test, complete blood count. * Age > 18, < 80 years * Patient must sign study specific informed consent prior to study entry. Exclusion Criteria: * Evidence of small cell histology * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Pregnant women are ineligible as the treatment involves unforeseeable risks to the participant and to the embryo or fetus. Patients with childbearing potential must practice appropriate contraception. * Patient has enrolled in a clinical trial that specifically does not allow IMRT treatment

Study Objectives For prognosis evaluation, investigators enroll gastric cancer patients who underwent radical gastrectomy and collect the laboratory examination and clinicopathological characteristics. Then independent risk factors for overall survival will be analysed. For predicting efficacy evaluation, investigators also collect information of patients first diagnosed with metastases. Diagnostic efficacy is analysed by receiver operator characteristic curve method. Conditions: Stomach Neoplasms Intervention / Treatment: PROCEDURE: radical gastrectomy Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * all patients were newly diagnosed with gastric cancer; * all patients were pathologically diagnosed; * all patients had pre-treatment coagulation test; * stage I-IV disease; * age≥18 years Exclusion Criteria: * accompanying or secondary to other tumors; * had history of venous thrombosis or received any anti-coagulation treatment; * acute infection or intravascular disseminated coagulation; * pregnancy or lactation; * history of neoadjuvant chemotherapy; * Lost to follow-up

Study Objectives The objective of this study is to investigate the potential association between finasteride (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden, Finland, and Norway from data in national registries. The primary hypothesis of this study is that the previously reported increased incidence of male breast cancer among finasteride users is explained by confounding factors. Conditions: Male Breast Cancer Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Participant's study medical information available in population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, or Sweden within the observation period of 1995 to 2013 * Male with breast cancer with medical information in one of the 4 country-specific registries in this study OR country- and age-matched control men without breast cancer and with medical information in one of the 4 country-specific registries * Study participant's exposure to finasteride is available Exclusion Criteria: For country- and age-matched control men without breast cancer * Previous cancer diagnosis or treatment for cancer except non-melanoma skin cancer * Previous prostatectomy * Finasteride or dutasteride use (dutasteride is a drug in the same class as finasteride) within first 6 months of registration in the prescription registers (new user design).

Study Objectives A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 15 - 45 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Conditions: Infections, Papillomavirus Intervention / Treatment: BIOLOGICAL: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine) Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: PREVENTION Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A female of Chinese origin, residing in China, aged between 15 - 45 years (inclusive) at the time of the first vaccination. * Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the subject's parent or Legally Acceptable Representative (LAR), and written informed assent must be obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects must have a negative urine pregnancy test. * Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or must be using adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Pregnant or breastfeeding. * Planning to become pregnant or likely to become pregnant * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days preceding and 30 days after the first dose of vaccine. Administration of some routine vaccines up to 8 days before the first dose of study vaccine is allowed. * Previous administration of components of the investigational vaccine. * Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. * Hypersensitivity to latex. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Known acute or chronic, clinically significant system conditions. * Cancer or autoimmune disease under treatment. * Acute disease at the time of enrolment. * History of chronic alcohol consumption and/or drug abuse.

Study Objectives 1. To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC. 2. To compare, in each patient, ctDNA longitudinal samples through treatment, and when available, with those of primary tumor and metastasis. Conditions: Solid Tumor, Adult Intervention / Treatment: PROCEDURE: research blood draws Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Confirmed diagnosis of stage IV malignancy, including any advanced solid tumors (including lymphoma) * Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-3 * Life expectancy ≥ 3 months * Patients must be able to provide consent * Patients can be enrolled in other interventional clinical trials Exclusion Criteria: * Age < 18-year-old

Study Objectives The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL. Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites. Conditions: Lymphoma, B-Cell Intervention / Treatment: GENETIC: Adenovirus Interferon gamma Location: Switzerland, United States, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must satisfy all the following criteria for entry into the protocol: Primary CBCL including (according to WHO/EORTC classification 2005) : * Primary cutaneous marginal zone B-cell lymphoma * Primary cutaneous follicle center B-cell lymphoma * Primary cutaneous diffuse large B-cell other than leg type * Histologically consistent with primary CBCL. * Relapse or active disease after radiotherapy or other adequate therapy if radiotherapy was contra-indicated (chemotherapy, surgical excision, interferonα, rituximab). * Performance status of 0, 1 on the Eastern Cooperative Oncology Group (ECOG) scale (See Appendix E). * Minimum Life Expectancy > 3 months. * Adequate blood count: hemoglobin >= 10.0 g/dL; White Blood Count (WBC) >= 3.0 x 109/L; and platelet count >= 75 x 109/L. * Adequate hepatic function: bilirubin =< 1.5 times the upper limit of normal and serum transaminase (SGOT and SGPT)=< 2.5 times the upper limit of normal. * Adequate renal function: creatinine =< 1.5 times the upper limit of normal. * Written informed consent from patient. Exclusion Criteria: Patients will be excluded from the study for any of the following reasons: * Primary cutaneous diffuse large B-cell lymphoma, leg type. * Primary cutaneous intravascular large B-cell lymphoma. * Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy). * No histologic documentation of CBCL. * History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections. * Serious uncontrolled, concomitant medical disorders. * Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab...(not limited listing) * Major surgery in previous 4 weeks preceding the 1st injection. * Pregnancy at study entry or who become pregnant during the study or women who are breast feeding. * Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection. * Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection. * Patient previously included in this study. * Non compliance with the study.

Study Objectives The goal of this observational study is to investigate the effect of non-selective beta-blocker (NSBB) on the recurrence of hepatocellular carcinoma (HCC) following liver transplantation in patients who underwent liver transplantation (LT) for treating hepatocellular carcinoma. The main question\[s\] it aims to answer are: * Is the usage of non-selective beta-blocker associated with decreased recurrence of hepatocellular carcinoma following liver transplantation? * Is the usage of non-selective beta-blocker associated with all-cause mortality following liver transplantation? Researchers will compare the NSBB group, including patients who received non-selective beta-blocker therapy for at least 30 consecutive days within 3 months prior to liver transplantation more than 30 days prior, with the control group to to see if non-selective beta-blocker treatment is associated with decreased recurrence of hepatocellular carcinoma following liver transplantation. Conditions: Hepatocellular Carcinoma Recurrent, Hepatocellular Carcinoma Intervention / Treatment: DRUG: Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adult patients * Underwent liver transplantation for treating hepatocellular carcinoma * Between Jan. 2008 - May. 2022 Exclusion Criteria: * Pediatric patients (Age under 18 years) * Re-transplantation * Multi-organ transplantation

Study Objectives The purpose of this research study is to compare a new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening. Conditions: Colorectal Cancer, Colorectal Carcinoma Intervention / Treatment: OTHER: Fecal Immunochemical Test (FIT) Kit, BEHAVIORAL: Culturally targeted Photo Novella Booklet, BEHAVIORAL: Screen for Life Brochure Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Community-based recruitment methods will be used including promotional flyers and word of mouth at locations such as churches, barber shops, civic/community social service centers, senior centers, cultural groups. The flyers will provide brief information and advertise a telephone number for potential participants to call the study office at Moffitt. * Self identify as Black or African American * Have no symptoms of colorectal cancer (CRC), or personal diagnosis of CRC or bowel inflammatory disease or related syndromes * Have not had recent CRC screening per guidelines (never screened or overdue) * Participants must provide at least two forms of contact information (mailing address, home telephone or cell phone or email address), and contact information of a secondary individual who has a number that is different from the participant (this person may be a relative or friend living with the respondent). * Spouse or relatives of respondent are potentially eligible. Exclusion Criteria: * Individuals who have participated in a colorectal cancer screening (CRCS) research in the past 1 year will not be eligible for this study. * Additional criteria may apply.

Study Objectives This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately Conditions: Recurrent Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma Intervention / Treatment: DRUG: Montanide ISA 51 VG, BIOLOGICAL: MART-1 antigen, OTHER: laboratory biomarker analysis, BIOLOGICAL: Gag:267-274 peptide vaccine, DRUG: resiquimod Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Central pathology review submission; this review for MART-1 positivity is mandatory prior to registration to confirm eligibility * Human leukocyte antigen (HLA)-A2-positive * Histologic proof of stage II, III or IV melanoma that has been completely resected with no current evidence of disease, as demonstrated by imaging within 2 months (stage III or stage IV; must be computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography \[PET\]/CT) or 6 months (stage II; may be chest x-ray, CT, MRI, or PET/CT) * Absolute neutrophil count (ANC) >= 1500 mL * Hemoglobin (Hgb) > 10 g/dL * Platelets (PLT) >= 50,000 mL * Aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) * Alkaline phosphatase =< 3 x ULN * Ability to provide informed consent * Willingness to return to Mayo Clinic Rochester for follow-up * Life expectancy >= 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * For women of childbearing potential, a negative serum pregnancy test =< 7 days prior to registration * Willingness to provide mandatory blood samples for correlative research Exclusion Criteria: * Uncontrolled or current infection * Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy * Known allergy to vaccine or adjuvant components * Any of the following prior therapies with interval since most recent treatment: * Chemotherapy =< 4 weeks prior to registration * Biologic therapy or immunotherapy =< 4 weeks prior to registration * Radiation therapy =< 4 weeks prior to registration * Failure to fully recover from side effects of prior chemotherapy or surgery * Any of the following, as this regimen may be harmful to a developing fetus or nursing child: * 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, or abstinence, etc.) * Known immune deficiency, including human immunodeficiency virus (HIV) infection, as patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine; in addition, study patients should be naive to the HIV-derived Gag267-274 antigen * History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine * Current or recent (=< 4 weeks prior to registration) use of immunosuppressive medications including systemic corticosteroids; (use of corticosteroids in doses not exceeding those used for adrenal replacement is acceptable) * History of brain metastases (even if completely resected) * Other active malignancy =< 5 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other treatment for their cancer

Study Objectives This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: Afatinib Location: Germany Study Design and Phases Study Type: OBSERVATIONAL

Inclusion criteria: * EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations * Age >= 18 years * No diagnostic or therapeutic measures beyond routine clinical practice are required * Patients for whom the treating physician has decided to initiate treatment with GIOTRIF * Written informed consent prior inclusion Exclusion criteria: * Contraindication for Afatinib according to the Summary of Product characteristics * Participation in another clinical study until 30 days after end of treatment * Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted) * Previous treatment with an EGFR-tyrosine kinase inhibitor * Patients not willing or not able to fill in quality of life questionnaires * Patients with missing or impaired legal capacity * Pregnancy

Study Objectives This study will be conducted in 5 parts (Parts A, B, C, D and E). Monotherapy Treatment: Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Monotherapy dose escalation will be performed in Part A. Cycle 1 data from each cohort will be evaluated for safety and dose-limiting toxicities (DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in which a patient is enrolled and cohorts will be dosed consecutively by ascending dose. Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified, an expanded cohort will be enrolled (Part B). Combination Treatment: Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Subjects will receive TRX518 in combination with gemcitabine (Part C), pembrolizumab (Part D), or nivolumab (Part E). Dose escalation will be performed for each part (Part Cesc, Part Desc, Part Eesc) and Cycle 1 data from each cohort will be evaluated for safety and dose-limiting toxicities (DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in which a patient is enrolled and cohorts will be dosed consecutively by ascending dose. Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified, an expanded cohort will be enrolled (Part Cexp, Part Dexp, Part Eexp). Conditions: Solid Tumors Intervention / Treatment: DRUG: TRX518 monotherapy, DRUG: TRX518 with gemcitabine, DRUG: TRX518 with pembrolizumab, DRUG: TRX518 with nivolumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Advanced Solid Malignancies: Histologically documented metastatic or locally advanced, incurable solid malignancy (Parts A and B); histologically documented metastatic or locally advanced, incurable solid malignancy for which gemcitabine is clinically appropriate (e.g., non-small cell lung, breast, ovarian, pancreatic, and renal cancer); histologically documented metastatic or locally advanced, incurable solid malignancy for which pembrolizumab (Part D) or nivolumab (Part E) is approved. NOTE: Parts D and E only: Subject has either (1) received treatment with pembrolizumab or nivolumab for ≥4 months with a best response of stable disease and plans to continue treatment with either pembrolizumab or nivolumab in accordance with package insert; or (2) is not currently taking, but is eligible for treatment with, pembrolizumab or nivolumab in accordance with the approved indications for each as referenced in the package insert. * Expected survival of at least 12 weeks after dosing. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Evidence of adequate organ function by standard laboratory tests. * All female subjects of child bearing age must be either surgically sterile, postmenopausal for at least 1 year, or using an acceptable method of contraception. Adequate contraception for both male and female subjects must be used from the beginning of the screening period until at least 8 weeks after the last dose of study drug. Exclusion Criteria: * Hematologic malignancies or multiple myeloma. * Known, clinically important cardiac or respiratory disease * Any concomitant serious physical illness other than cancer (e.g., immune deficiency disease, bleeding disorder, etc.) within 1 year prior to dosing. No history of autoimmune disease. * Active, uncontrolled infections within 7 days of study entry requiring systemic therapy. * Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS metastases within 30 days prior to dosing. * History of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment. (Parts C, D and E only). * Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis (Parts D and E only). * Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment (Parts D and E only). * History of (non-infectious) pneumonitis that required steroids or current pneumonitis (Parts D and E only). * History of interstitial lung disease (Parts D and E only).

Study Objectives Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia. Conditions: Cancer Intervention / Treatment: PROCEDURE: Injection of HX-4 Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options. * Normal white blood cell count and neutrophils * Normal platelet count * No anaemia requiring blood transfusion or erythropoietin * Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution). * Calculated Creatinin clearance at least 60 ml/min * No administration of Fluor-18 in the previous 24 hours * Capable of complying with study procedures

Study Objectives This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed. Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-59R5 every week until disease progression. Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14 subjects will be enrolled at the highest dose level that result in \<2 of the 6 subjects experiencing a DLT. Conditions: Solid Tumors Intervention / Treatment: DRUG: OMP-59R5 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI. * Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C. * Age >18 years * ECOG performance status <2 (see Appendix B) * Life expectancy of more than 3 months * Subjects must have normal organ and marrow function as defined below: * Absolute neutrophil count >1000/mL * Hemoglobin >9.0 g/dL * Platelets >100,000/mL * Total bilirubin <1.5 X institutional upper limit of normal (ULN) * AST (SGOT) and ALT (SGPT) < 3 X institutional ULN (for subjects with hepatic metastases < 5 X institutional ULN) * PT and PTT within 1.5 X institutional ULN * Creatinine <1.5 X institutional ULN OR * Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal * Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Subjects receiving any other investigational agents * Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease * History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy * Significant 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 or nursing women * Subjects with known HIV infection * Known bleeding disorder or coagulopathy * Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents. * New York Heart Association Classification II, III, or IV * Subjects with a blood pressure of >140/90 mmHg. The blood pressure must be taken three times 10 minutes apart. Subjects taking antihypertensive medications must be taking ≤ 2 medications to obtain this level of blood pressure control. * Subjects with EKG evidence of ischemia or ≥ Grade 2 ventricular arrhythmia, subjects who have a history of acute myocardial infarction within 6 months, or subjects with unstable angina. * Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease. * Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease. * Subjects with >1 grade 1 diarrhea.

Study Objectives Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program. Conditions: Breast Cancer Location: Germany Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy * Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve) * Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months * In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years. Exclusion Criteria: * Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function * Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen * Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0) * Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program

Study Objectives The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf (BLENREP) and associated patterns of care, including dosing and dose modification, eye care specialist visits, associated healthcare utilization, and clinical outcomes in patients with relapsed and/or refractory multiple myeloma (RRMM) seen in the Duke Cancer Institute (DCI) clinics. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Blenrep Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age > 18 years of age as of start of treatment with BLENREP * Patients with a corresponding diagnosis code consistent with multiple myeloma seen at Duke. * Patients with a record of starting treatment with BLENREP for RRMM between August 5, 2020 and November 22, 2022. * Patients having healthcare encounters at Duke Cancer Institute (DCI) for at least 1-month after start of Blenrep treatment. Exclusion Criteria: * Patients who were included in any clinical trial for BLENREP including expanded access clinical trials * Age > 89 years of age as of start of index therapy

Study Objectives The purpose of this study is to evaluate the potential effects of rifampin on blood levels of trabectedin after administration to patients with advanced malignancies. Conditions: Neoplasm Metastases Intervention / Treatment: DRUG: Sequence 1, DRUG: Sequence 2, DRUG: Sequence 1, DRUG: Sequence 2 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Patients with locally advanced or metastatic disease, any solid tumor except hepatocellular carcinoma, who have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy * Patients with Eastern Cooperative Oncology Group (ECOG) score of <=2 * Patients able to receive dexamethasone * Patients with hepatic function variables: total bilirubin <=upper limit of normal (ULN), alkaline phosphatase (ALP) <=1.5 ULN and liver function test results (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) of <=2.5x ULN Exclusion Criteria: * Patients with previous exposure to trabectedin * Patients with cancer that has metastasized (spread) to the central nervous system * Patients with known liver disease * Patients who had a myocardial infarct (heart attack) within 6 months before enrollment or who have any other clinically significant or unstable medical condition as assessed by the Investigator * Patients unable to have a central catheter

Study Objectives Chemotherapy-associated peripheral neuropathy is a common complication in patients receiving taxane and platinum-based chemotherapy. Peripheral neuropathy may cause the patient's daily life activities to be hindered, quality of life to deteriorate, treatment dose reduced, or even discontinuation of treatment. In the literature, different studies have been carried out using many pharmacological and non-pharmacological approaches in the management of this problem, but so far, any approach that has been shown to be effective in its management has not been clearly defined. One of the approaches whose effectiveness is evaluated in management is exercise. There have been published case reports and several experimental studies examining small patient groups on this subject, and it has been shown to have significant benefits in the management of peripheral neuropathy. This study was planned to determine whether exercise is an effective method in the management of chemotherapy-associated peripheral neuropathy in oncology patients. Conditions: Chemotherapy-induced Peripheral Neuropathy, Chemotherapeutic Toxicity Intervention / Treatment: OTHER: Hand-foot exercise, OTHER: The routine care Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Patients who received at least 3 cycles of taxane and platinum-based treatment (monotherapy or combined) and developed grade 2 or higher peripheral neuropathy as a result of motor and sensory neuropathy evaluation (lung cancer, breast cancer, gynecological cancers, colorectal cancers), Patients with stable vital signs who can tolerate exercise, * No bone metastases, * Patients older than 18 years old, * Patients who agree to participate in the study will participate. Exclusion Criteria: * Newly starting chemotherapy, Peripheral neuropathy due to problems other than chemotherapy (tumor compression, nutritional disorders, infections and systemic diseases such as diabetes mellitus), Vital signs that cannot tolerate exercise are non-stable, Bone metastases, * Patients with impaired skin integrity in their hands and feet and who do not agree to participate in the study will not be included in the study.

Study Objectives This prospective observational study will evaluate the evolution of lung cancer related symptoms and their correlation with the disease control rate (complete response, partial response and stable disease) in patients with non-small cell lung cancer initiating first-line treatment with standard platinum-based chemotherapy with or without Avastin (bevacizumab). Data will be collected from each patient at baseline and after 4-6 cycles of chemotherapy. Conditions: Non-Squamous Non-Small Cell Lung Cancer Location: Spain Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adult patients, >= 18 years of age * Histologically or cytologically confirmed non-small cell lung cancer * Initiating first-line treatment with standard platinum-based chemotherapy, with or without bevacizumab Exclusion Criteria: * Contraindications to the use of platinum-based chemotherapy

Study Objectives A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer. Conditions: Carcinoma, Pancreatic Ductal, Pancreatic Cancer, Pancreatic Disease Intervention / Treatment: BIOLOGICAL: AGS-1C4D4, BIOLOGICAL: Gemcitabine Location: Spain, United States, Russian Federation, France, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded * Non-measurable or measurable disease based on the RECIST criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Life expectancy of > 3 months * Hematologic function, as follows: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelet count ≥ 100 x 109/L * Hemoglobin ≥ 9 g/dL (transfusion independent) * Renal function, as follows: * Creatinine ≤ 2.0 mg/dL * Hepatic function, as follows: * Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases. * Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases * Bilirubin ≤ 2 x ULN * INR < 1.3 (or ≤ 3 if on warfarin for therapeutic anti-coagulation) Exclusion Criteria: * Prior systemic therapy for metastatic pancreatic cancer * Subjects who have received adjuvant treatment with gemcitabine and who had relapse metastatically are allowed * Subjects with advanced local disease who have received treatment with gemcitabine and in whom progression has been observed with the onset of metastases less than 6 months are excluded * Chemotherapy and/or radiation within 4 weeks of study enrollment * Prior monoclonal antibody therapy within 60 days of study enrollment * Known brain or leptomeningeal disease * History of other primary malignancy, unless: * Curatively resected non-melanomatous skin cancer * Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years * Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) * Use of any investigational product within 4 weeks of study enrollment * Major surgery (that requires general anesthesia) within 4 weeks before study enrollment * Women who are pregnant (confirmed by positive pregnancy test) or lactating * Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration * Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive * Active serious infection not controlled with antibiotics

Study Objectives RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) scan and computated tomography (CT) scan, may help doctors predict a patient's response to treatment and may help plan the best treatment. Drugs used in chemotherapy, such as doxorubicin and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well PET scan combined with CT scan predicts response in patients undergoing chemotherapy and surgery for soft tissue sarcoma. Conditions: Sarcoma Intervention / Treatment: BIOLOGICAL: pegfilgrastim, DRUG: doxorubicin hydrochloride, DRUG: ifosfamide, DRUG: pegylated liposomal doxorubicin hydrochloride, PROCEDURE: conventional surgery, RADIATION: fludeoxyglucose F 18 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically confirmed, high grade, soft tissue sarcoma including * malignant fibrous histiocytoma, * liposarcoma, * fibrosarcoma, * leiomyosarcoma, * synovial carcinoma, * malignant peripheral nerve sheath tumor (MPNST), * epithelioid sarcoma, and * sarcomas-not otherwise specified. NOTE: Ewings sarcoma, primitive neuroectodermal tumor, extraskeletal, osteosarcoma, extraskeletal chondrosarcoma, alveolar soft part sarcoma, rhabdomyosarcoma, carcinosarcoma, Kaposi's sarcoma, angiosarcoma, and mesothelioma patients are ineligible for this study. * Measurable disease using traditional cross section measurements with the primary site's largest diameter > 5 centimeters by positron emission tomography/computated tomography (PET/CT), CT or magnetic resonance imaging (MRI) scan. Patients with either localized (primary or locally recurrent) or metastatic disease at presentation are eligible for study if they are to receive neoadjuvant treatment prior to excision of the primary (stage IIC, III, IVA, IVB.) * Age ≥ 16 years, Karnofsky ≥ 70% * Adequate organ function for receiving chemotherapy as determined by the treating physician. * Women of childbearing potential and sexually active males are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study. Exclusion Criteria: * Previous treatment with chemotherapy or radiation therapy * Females known to be pregnant or breast-feeding are excluded because PET/CT scan in pregnant women is not FDA approved. * Serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study. Patients with PET-CT as an indicator of disease survival in soft tissue sarcoma untreated or symptomatic CNS metastases or uncontrolled diabetes will not be eligible. Patient must give written informed consent indicating the investigational nature of the study and its potential risks.

Study Objectives The study will evaluate the safety, tolerability and efficacy of LUT014 gel topically administered in breast cancer patients who developed radiation dermatitis. Subjects enrolled to part 1 will be enrolled to receive the study treatment (open label treatment) for 28 days and will be followed up for 2 months after the completion of study treatment. Subject in Part 2 will be randomized in 1:1 ratio to receive either the study drug or placebo (double-blind treatment) for qd topical application for 28 days and will be followed up for 2 months after the completion of study treatment. Conditions: Radiation Dermatitis Intervention / Treatment: DRUG: LUT014 Gel, DRUG: Placebo for LUT014 Gel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Female subjects diagnosed with stage Tis, T0-T3, N0-N2, M0 Breast Cancer; * Subject is ≥18 years at the time of signing the informed consent form (ICF); * Radiation dermatitis of Grade 2, based on the NCI CTCAE at the Screening and Baseline (D0) visits; * Completed fractionated radiation therapy for breast prior to first dose of study drug (Day 0); * A score of ≥ 6 reported in the Dermatology Life Quality Index at the Screening and Baseline Visits; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * Females of child-bearing potential must have a negative pregnancy test at screening and must agree to use an effective contraception method\* or abstain from sex throughout the study until Day 83; * Expected life expectancy greater than 6 months Exclusion Criteria: * Bilateral breast irradiation; * Planned internal mammary node irradiation with electrons. Planned photon coverage of internal mammary chain nodes is acceptable for inclusion in this study; * Planned partial breast accelerated irradiation; * Any cutaneous infection or significant skin disease at Screening or Baseline (Day 0) other than the dermatitis in the area(s) irradiated during fractionated radiation therapy; * T4 breast cancer or direct skin involvement by breast cancer; * Breast implants or underwent breast reconstruction; * Any cancer other than breast cancer within 3 years of Screening, except for carcinoma in situ of the cervix; * Pregnant or lactating; * History of active systemic lupus erythematosus or scleroderma that is believed to increase the risk of developing radiation-induced dermatitis or its severity; * Clinically significant co-morbid diseases * Treatment with a serine/threonine-protein kinase B-Raf (B-Raf) inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), Braftovi® (encorafenib), and Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer; * Treatment with a topical corticosteroid o the irradiated chest area within 14 days prior to Baseline (Day 0). * Treatment with a systemic corticosteroid within 14 days prior to Baseline (Day 0), except for low dose systemic corticosteroids (e.g., 8-20 mg dexamethasone or comparable) given for up to one or two days every two weeks as part of standard of care for the prevention or treatment of chemotherapy-induced nausea and vomiting (CINV); * Treatment with any investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer; * Known hypersensitivity to any of the inactive ingredients of the study drug.

Study Objectives incidence of detection of carcinogenic types of human papilloma virus in 60 cases of cervical cancer Conditions: Cervical Cancer Intervention / Treatment: DIAGNOSTIC_TEST: human papilloma virus testing and genotyping in cervical cancer cases Location: Egypt Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * cervical cancer Exclusion Criteria: * none

Study Objectives The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: Azacitidine, DRUG: Conventional Care Regimen Location: Czechia, Spain, United States, China, Italy, Germany, Israel, France, Russian Federation, Canada, Belgium, Netherlands, Poland, Taiwan, Austria, Korea, Republic of, United Kingdom, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Diagnosis of one of the following * Newly diagnosed de novo acute myeloid leukemia (AML) * AML secondary to myelodysplastic syndromes (MDS) * AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years * Bone marrow blasts >30% * Age ≥ 65 years * Easter Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: * Previous cytotoxic or biologic treatment for AML (except hydroxyurea) * Previous treatment with azacitidine, decitabine or cytarabine * Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors) * AML French American British subtype (FAB M3) * AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes * Prior bone marrow or stem cell transplantation * Candidate for allogeneic bone marrow or stem cell transplant * Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure) * Malignant hepatic tumors * Uncontrolled systemic infection * Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C * Use of any experimental drug or therapy within 28 days prior to Day 1

Study Objectives Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of both venous and arterial thrombosis. Thrombotic complications are the main determinant of morbidity and in a less extend mortality. Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a hypercoagulable state. However, previous evidence suggests that global coagulation tests such as thrombin generation or thromboelastometry are able to detect signs of procoagulant imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an hypercoagulable state. Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed for PV and are under investigations on clinical trial for ET. It is currently unknown if treatments that were used for ET and PV, and especially JAKi are able to modify the hypercoagulable state that is observed in those diseases, and if there is difference between drugs. To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment. Conditions: Polycythemia Vera, Thrombocythemia, Essential Intervention / Treatment: DRUG: No cytoreductive vs cytoreductive drugs Location: Switzerland, United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * All men and women, older than 18 years, with a diagnosis of PV or ET (primary or secondary) according to the 2008 World Health Organization (WHO) classification. Exclusion Criteria: * Lack of participant's consent; * Concomitant treatment with anticoagulant drugs (anti-vitamin K, heparin or direct oral anticoagulant drugs); * Active cancer other than non-melanoma skin cancer (defined as cancer diagnosis <5 years or treatment <2 years); * Recent infection (<30d); * Recent surgery (<30d); * Recent hospitalization (<30d); * Recent thromboembolic or cardiovascular event (<3m).

Study Objectives Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity. Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group. Conditions: Cancer Intervention / Treatment: BEHAVIORAL: Activity Monitor, BEHAVIORAL: Interactive Website, BEHAVIORAL: Educational Materials Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH) * 11 through 14 years of age * Not undergoing active treatment for cancer * Medical clearance from participant's attending physician via email * Does not meet the Centers for Disease Control (CDC) physical activity guidelines. CDC guidelines for children age 11 to 14 are defined as 60 minutes or more per day of physical activity, seven days a week * Internet access and a computer that has software that is compatible with the study device (Windows XP, Windows Vista, Windows 7, Mac OSX 10.5 and Mac OSX 10.6) Exclusion Criteria: * Global cognitive impairment (Full Scale Intelligence Quotient < 70) that prevents use of the interactive website * Pregnant female * Inability to read and write English

Study Objectives BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. We sought to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the colorectum, which may be a potential factor in adverse anastomosis complications following IPAA surgery. METHODS: Individuals who received infliximab as maintenance therapy and who received their last dose within 180 days of the first stage of IPAA were selected. The control group comprised UC patients who were not exposed to anti-TNF therapy, matched by age, sex, BMI, disease duration, albumin levels, and post-operative leak outcome. Hematoxylin and eosin- (H\&E) and trichrome-stained slides from the most distal, well-oriented, full-thickness section of colorectum from each patient's total colectomy specimen were evaluated. Blinded assessment of the degree of fibrosis in the lamina propria, the submucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale. Conditions: Ulcerative Colitis, Anti TNF Therapy, Ileal Pouch Anal Anastomosis (IPAA) Intervention / Treatment: DRUG: Anti-TNF Drug Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed . Exclusion Criteria: * Patients with CD * Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .

Study Objectives To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy Conditions: Anemia Intervention / Treatment: DRUG: darbepoetin alfa Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * patients diagnosed as lung or gynecological cancer * patients receiving platinum containing chemotherapy * written informed consent * hemoglobin concentration less than 11 d/dL at enrollment * life expectancy of more than 4 months Exclusion Criteria: * hemolysis, gastrointestinal bleeding, postoperative bleeding * iron deficiency * megaloblastic anemia * any primary hematological disorder that could cause anemia * received > 2 RBC transfusions with 4 weeks or any RBC transfusion within 2 weeks before randomization * prior treatment with KRN321 * received erythropoetin therapy within 8 weeks before treatment

Study Objectives Continuous dosing of BAY73-4506 in patients with advanced cancer Conditions: Neoplasm Intervention / Treatment: DRUG: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg, DRUG: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg, DRUG: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg, DRUG: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg, DRUG: Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg, DRUG: HCC Child-Pugh A expansion cohort: Regorafenib 100 mg, DRUG: HCC Child-Pugh B expansion cohort: Regorafenib 100 mg, DRUG: NSCLC expansion cohort: Regorafenib 100 mg Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * 18 years * Patients with advanced, histologically or cytologically confirmed solid tumors, malignant lymphomas, or multiple myeloma refractory to any standard therapy * Radiographical, hematological or clinically evaluable tumor * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 * Life expectancy of at least 12 weeks * Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements: * Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) * Signed informed consent must be obtained prior to any study specific procedures Exclusion Criteria: * History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) * Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management * History of HIV infection or chronic hepatitis B or C * Active clinically serious infections (> Grade 2 NCI Common Terminology Criteria for Adverse Events v3.0) * Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Patients with brain metastases must not be undergoing acute steroid therapy or steroid taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies) * Substance abuse, medical, psychological or social conditions that may interfere with the patient178s participation in the study or evaluation of the study results * Radiotherapy to the target lesions within 3 weeks prior to Day 1, Cycle 1 (first dose of study drug). (Palliative radiotherapy will be allowed). Radiotherapy to the target lesions during study will be regarded as progressive disease * Previous or concurrent cancer which is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis and T1\] or any cancer curatively treated > 3 years prior to study entry.

Study Objectives This randomized pilot trial studies how well higher or lower dose cladribine, cytarabine, and mitoxantrone work in treating medically less fit patients with newly diagnosed acute myeloid leukemia or myeloid neoplasm. Drugs used in chemotherapy, such as cladribine, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cladribine, cytarabine, and mitoxantrone at higher or lower dose may work better in treating patients with newly diagnosed acute myeloid leukemia. Conditions: Acute Leukemia of Ambiguous Lineage, Acute Myeloid Leukemia, Myeloid Neoplasm Intervention / Treatment: DRUG: Cladribine, DRUG: Cytarabine, BIOLOGICAL: Granulocyte Colony-Stimulating Factor, DRUG: Mitoxantrone Hydrochloride, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Diagnosis of untreated "high-grade" myeloid neoplasm (>= 10% myeloid blasts by morphology in bone marrow and/or peripheral blood) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 World Health Organization (WHO) classification; patients with acute leukemias of ambiguous lineage are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available * Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model * The use of hydroxyurea before enrollment is permitted; hydroxyurea should be discontinued prior to start of study treatment. Patients with symptoms/signs of leukostasis, white blood cell (WBC) > 100,000/uL, or acute symptoms felt related to their high-grade myeloid neoplasm can be treated with leukapheresis or may receive up to 1 dose of cytarabine (up to 500 mg/m\^2) anytime prior to study day 1 * Patients may have received treatment (e.g. azacitidine/decitabine, lenalidomide, growth factors) for antecedent low-grade myeloid neoplasm * Left ventricular ejection fraction (LVEF) >= 45%, assessed within 3 months prior to registration, e.g. by multigated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality * Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 4 weeks after the last dose of study drug * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment * Concomitant illness associated with a likely survival of < 1 year * Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable; patients with fever thought to be likely secondary to leukemia are eligible; known hypersensitivity to any study drug * Known hypersensitivity to any study drug used in this trial * Pregnancy or lactation * Concurrent treatment with any other anti-leukemia agent

Study Objectives There are three arms to this study (A, B and C) The purpose of this research study during Arm A is to see how much of PF-00299804 gets into the brain tumor. For many brain tumors, one reason that chemotherapy drugs might not be effective is that the drug may not be able to get into the brain tumor and kill the cancer cells. We will determine how much PF-00299804 gets into the brain tumor by obtaining a sample of the tumor from the surgery that the participant already has scheduled. The purpose of this research study during Arm B and C, is to determine how well PF-00299804 works in killing cancer cells. PF-00299804 works by binding to specific proteins found on the surface of some cancer cells that promote a growth signal. Blocking this signal from reaching its target on the cancer cells may slow or stop the cancer from growing. Conditions: Glioblastoma, GBM, Glioblastoma Multiforme Intervention / Treatment: DRUG: PF-00299804 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * 18 years of age or older * Histologically confirmed diagnosis of a recurrent primary WHO grade IV malignant glioma (glioblastoma). Patients with recurrent disease whose diagnostic pathology confirmed glioblastoma will not need re-biopsy. Patients with prior low-grade glioma or anaplastic glioma are eligible if histologic assessment demonstrates transformation to GBM. * Evidence of EGFR gene amplification by fluorescence in situ hybridization (FISH) in archival tumor material. * Patients must have at least 15 unstained slides or 1 tissue block (frozen or paraffin embedded) available from a prior biopsy or surgery. * For Arm A: patients must be at first recurrence of GBM, must not have had previous anti-VEGF therapy, and must be candidates for surgical partial or gross-total resection. * For Arm B: patients must be at first recurrence of GBM and must not have had prior anti-VEGF therapy. * For Arm C: patients may have had an unlimited number of prior therapies for GBM, however must be at first recurrence from a therapeutic regimen containing bevacizumab * Progressive disease on contrast-enhanced brain CT or MRI as defined by McDonald Criteria, or have documented recurrent glioblastoma on diagnostic biopsy. * Prior to enrollment, there must be an interval of at least 2 weeks between prior surgical resection (1 week for intracranial biopsy) and adequate wound healing. * Interval of at least 12 weeks from prior radiotherapy unless there is either: a) histopathologic confirmation of recurrent tumor, or b) new enhancement on MRI outside of XRT treatment field. * Patients must have sufficient time to recover from prior therapy. * Karnofsky Performance Score 70% or greater * Adequate hematologic and liver function as outlined in the protocol * Creatinine within normal institutional limits * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation and for at least 3 months thereafter. Exclusion Criteria: * Presence of extra-cranial metastatic disease * Participants may not be receiving any other investigational agents * Prior investigational therapy with an agent that is known or proposed to be active by action on any component of the EGFR tyrosine kinase, IGF1R, mTor, orc-MET pathways * Patients who have been previously treated with an anti-VEGF agent will be excluded from Arm A and Arm B. * Patients must not have received prior Gliadel wafers * For participants in Arm A, if the diagnostic pathology of the biopsy specimen is not consistent with recurrent glioblastoma, then the participant must be taken off study and be replaced with another participant that meets the inclusion criteria and is eligible for surgical resection. * Any surgery (not including minor diagnostic procedures such as lymph node biopsy) within 2 weeks of baseline disease assessments; or not fully recovered from any side effects of previous procedures. * Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug. * Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol * Patients with known interstitial lung disease * Uncontrolled or significant cardiovascular disease * Any patient with a history of significant cardiovascular disease, even if currently controlled, or who has signs or symptoms suggesting impaired left ventricular function in the judgment of the investigator must have a screening left ventricular ejection fraction evaluation by ECHO or MUGA. Patients with LVEF measurements below local institutional lower limit of normal or less then 50% will not be eligible. * Individuals with a history of a different malignancy are ineligible except for the circumstances outlined in the protocol * Patients who have had prior stereotactic radiotherapy, convection enhanced delivery or brachytherapy as gliosis/scarring from these modalities may limit delivery * Patients will not be eligible if they present with leptomeningeal dissemination * Pregnant women * HIV-positive individuals on combination antiretroviral therapy are ineligible * History of allergic reactions attributed to compounds of similar chemical or biologic composition to PF-00299804 * Other severe acute or chronic medical condition, uncontrolled intercurrent illness or laboratory abnormality that may increase the risk associated with trial participation or investigation product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.

Study Objectives Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation. Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal. The aim of this study is to assess the prognostic role of PTEN in terms of Progression free survival. Although the role of Cetuximab as first line treatment in metastatic CRC will be soon established, it is still unclear which is the best schedule for Cetuximab and the role of biological factors in order to select the most appropriate subset of pts for recommending Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the perspective to study the role of other molecular markers in this subset of pts. On the basis of these considerations this study is aimed at testing a different schedule of Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Cetuximab, DRUG: FOLFIRI Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria * Signed written informed consent for biological analysis (all pts) * Signed written informed consent for enrolment (pts with KRAS wild type) * Male or female aged > or = 18 years * Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * KRAS evaluation availability with wild-type result * Metastatic CRC not suitable for curative-intent resection * Availability of tumour samples (or able and willing to provide tumour sample) and blood for biological analysis * Presence of at least one lesion measurable unidimensionally by computed tomography (CT) scan or magnetic resonance imaging (MRI). (index lesion(s) must not lie within an irradiated area) * Eastern cooperative oncology group-performance status (ECOG-PS) <2 Exclusion criteria * Brain metastasis (known or suspected) * Previous chemotherapy for metastatic CRC (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months * Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry * Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Any investigational agent(s) within 4 weeks prior to entry * Previous exposure to HER-axis -pathway targeting therapy * Leucocytes <3.0 x 109/L and neutrophils <1.5 x 109/L, platelets <100 x 109/L, and hemoglobin <9 g/dL * Bilirubin level either normal or >1.5 x ULN * ASAT and ALAT >2.5 x ULN (>5 x ULN if liver metastasis are present) * Serum creatinine >1.5 x ULN * Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months * Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease * Pre-existing neuropathy > grade 1 * Known grade 3 or 4 allergic reaction to any of the components of the treatment * Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Pts with a previous malignancy but without evidence of disease for > or equal 5 years will be allowed to enter the trial) * Pregnancy or lactation * Inadequate contraception (male or female pts) if of childbearing or procreational potential * Known drug abuse/ alcohol abuse * Legal incapacity or limited legal capacity * 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 This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery. Conditions: Gastric Adenocarcinoma, Stage II Gastric Cancer, Stage III Gastric Cancer, Stage IV Gastric Cancer Intervention / Treatment: DRUG: Cisplatin, PROCEDURE: Computed Tomography, RADIATION: Fludeoxyglucose F-18, OTHER: Fluorothymidine F-18, DRUG: Irinotecan Hydrochloride, PROCEDURE: Positron Emission Tomography, PROCEDURE: Therapeutic Conventional Surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * All patients must have microscopically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction with material reviewed by the Department of Pathology of the participating Institution; tumors involving the GE junction must have the bulk of their disease in the stomach; tumors of the distal esophagus that extend less than 2cm into the stomach are ineligible for this study; using the Siewert's classification for the GE junction, tumors designated as Types II and III are indeed considered eligible for this clinical trial * All patients must have localized cancer potentially curable by surgery; the tumor stage should be Tany N+ M0 or T3-T4 Nany M0, by staging that includes a computed tomography (CT) scan and either laparoscopy-assisted pancreatobiliary (LAP) or endoscopic ultrasound (EUS); patients with T1-2N0M0 tumors, confirmed by LAP ("good risk") are ineligible; any sites of suspected M1 disease by these criteria must be proven to be M0 prior to entrance into a neoadjuvant trial * Patients must have a Karnofsky Performance Status >= 60% (Eastern Cooperative Oncology Group \[ECOG\] =< 2) and be able to tolerate the proposed surgical procedure and chemotherapy regimen * Patients may not have received prior chemotherapy or radiation for this disease * Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3 * Platelets >= 100,000/mm\^3 * Serum creatinine =< 1.5 mg/dL * Total serum bilirubin =< 1.5 mg/dL * Patients must have signed informed consent indicating that they are aware of the investigational nature of the study and that participation is voluntary * No clinically significant auditory impairment * No clinically significant peripheral neuropathy * New York Heart Association (NYHA) class I-II * Patients must not have a prior history of cancer within the last five years except for non-melanoma skin cancer, non-metastatic prostate cancer or carcinoma in situ of the uterine cervix Exclusion Criteria: * Any metastatic disease * NYHA Class III or IV heart disease; history of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics or a history of a clinically significant conduction system abnormality * Pregnant or lactating women are ineligible; fertile men and women, unless using effective contraception, are ineligible; a pregnancy test will be performed on sexually active women of childbearing potential prior to entry into the study; treatment may not begin until the results of the pregnancy test are ascertained * Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy * Grade 2 or greater pre-existing peripheral neuropathy * Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol * Any concurrent active malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer or carcinoma-in-situ of the uterine cervix; patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial * Clinically significant hearing loss

Study Objectives The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria). The secondary objectives are: * to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria, * to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: larotaxel (XRP9881), DRUG: docetaxel, DRUG: trastuzumab Location: Germany, France, Brazil, Poland, Belgium, Uruguay, Tunisia, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically proven invasive breast adenocarcinoma * Localized breast cancer: stage II and III * Tumors clinically palpable and ineligible for breast conservative surgery: unifocal tumor with diameter ≥ 3cm (clinical examination) or central unifocal tumor, or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate) * After 30 June 2008, known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH) Exclusion Criteria: * Bilateral and inflammatory breast cancer * Abnormal Left Ventricular Ejection Fraction * Distant metastases or locoregional relapse * Inadequate organ functions The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy. Conditions: Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia Intervention / Treatment: DRUG: lipegfilgrastim, DRUG: pegfilgrastim Location: Spain, Italy, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Signed and dated Independent Ethics Committee (IEC)-approved written informed consent * Age ≥65 years and ≤85 years * Histological documentation of aggressive B cell NHL * Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards * ECOG score ≤2 * Life expectancy of at least 3 months * Adequate bone marrow, renal and hepatic function within 14 days before start of chemotherapy * The patient is capable of understanding and complying with parameters as outlined in the protocol * Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment and for 30 days after discontinuation of study drug. * The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the treatment (and for 90 days after taking the last dose of study * Other Criteria apply, please contact the investigator for more information Exclusion Criteria: * Participation in a clinical study within 30 days before randomization * Any chemotherapy within the last 3 months before start of chemotherapy. A prephase to reduce tumor burden prior to start of R-CHOP is allowed. * The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy. * Active cardiac disease * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of chemotherapy. * Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C. * Patients with evidence or history of bleeding diathesis. * Non-healing wound, ulcer or bone fracture. * Renal failure requiring hemo- or peritoneal dialysis. * Any conditions that may interfere with the patient's participation in the study or evaluation of the study results. * Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. * Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study. * Treatment with lithium at screening or planned during the study. * Other Criteria apply, please contact the investigator for more information

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or anemia. PURPOSE: This randomized phase III trial is studying how well giving zosuquidar trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment. Conditions: Leukemia, Myelodysplastic Syndromes Intervention / Treatment: BIOLOGICAL: filgrastim, BIOLOGICAL: sargramostim, DRUG: cytarabine, DRUG: daunorubicin hydrochloride, DRUG: zosuquidar trihydrochloride, DRUG: Placebo Location: United States, Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: One of the following disorders: * Acute myeloid leukemia (AML), defined as >30% myeloblasts on the marrow aspirate or peripheral blood differential and any French-American-British (FAB) subtype except M3 (i.e., acute promyelocytic leukemia) * Refractory anemia with excess blasts (RAEB), defined as 11-20% myeloblasts on bone marrow aspirate or peripheral blood differential, provided there are other criteria for high-risk disease * Refractory anemia with excess blasts in transformation (RAEB-T), defined as 21-30% myeloblasts on bone marrow aspirate or peripheral blood differential * Participants may have secondary AML * Age greater than 60 years * ECOG performance status of 0 to 3 * Total serum bilirubin < 3 mg/dL * Serum creatinine < 2 mg/dL * Cardiac ejection fraction of > 45% Exclusion Criteria: * Blastic transformation of chronic myelogenous leukemia * CNS leukemia * Prior chemotherapy for AML, with the exception of hydroxyurea * For women: pregnant or breast feeding * Other malignancy for which participant is currently receiving treatment * Concurrent treatment with other colony-stimulating factors

Study Objectives This study is being done to test a new treatment plan for large tumors in the sinus or nasal cavity that will include endoscopic surgery plus chemotherapy and proton-beam radiation therapy. Conditions: Paranasal Sinus Cancer, Nasal Cavity Tumor, Nasal Cavity Adenocarcinoma Intervention / Treatment: DRUG: Cisplatin, RADIATION: Adjuvant Proton Radiotherapy, PROCEDURE: Endoscopic Resection, DRUG: cisplatin and etoposide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age greater than or equal to 18 years. * Histopathologically confirmed diagnosis of one the following cancer types: * Squamous cell carcinoma * Esthesioneuroblastoma * Adenoid cystic carcinoma * Adenocarcinoma * Paranasal sinus/nasal cavity malignancy is considered unresectable with negative margins surgery or resection would be considered excessively morbid. This could include lesions with: * Carotid involvement * Cavernous sinus invasion * Brain invasion * Orbital apex * Intraconal space * Pterygoid musculature involvement * Invasion of the clivus * Resection of at least 80% of the volume of the tumor is feasible. Resectability will be determined by the surgeon and radiologist after discussion among the multidisciplinary team. For patients who have had surgery at an outside institution, the same parameters will be thoroughly screened to ensure the patient met the same inclusion criteria and resection standards. * Patients must be a candidate for surgery (as per treating surgeon) and be able to tolerate proton radiation and chemotherapy (as per treating radiation oncologist and medical oncologist). * Karnofsky performance statue >= 70 * The subject has organ and marrow function and laboratory values rendering safe administration of Cisplatin: * The ANC >= 1000/mm3 without colony stimulating factor support * Platelets >= 100,000/mm3 * Hemoglobin >= 9 g/dL * Bilirubin <= 1.5 mg/dL the ULM. For subjects with Gilbert's disease, bilirubin <= 3.0 mg/dL * Serum albumin >= 2.8 g/dl * Creatinine clearance (CrCl) >= 60 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used: * Male: CrCl (mL/min) = (140 = age) x wt (kg) / (serum creatinine x 72) * Female: Multiply above result by 0.85 * ALT and AST <= 3.0 ULN * Serum phosphorus, calcium, magnesium and potassium >= LLN * No evidence of intercurrent infection * Negative pregnancy test for women of childbearing potential (<51 years of age) as per institutional policy. * Patients with distant metastatic disease may not be included. * Patient must be able to read and write in English. * Patients who intitially meet the histopathological inclusion criteria but surgical pathology report shows Sinonasal Undifferentiated Carcinoma. Exclusion Criteria: * Tumor is deemed to be resectable with negative margins by conventional surgical standards. * Patients not able to receive standard-dose cisplatin based on the judgement of the treating medical oncologist. * Patients with chronic kidney disease (GFR <60), uncontrolled hypertension, congestive heart failure, pre-existing bone marrow dysfunction, or cytopenias. ° Congestive heart failure (CHF): New York Heart Association (NYHA) Class II-IV at the time of screening * Concurrent uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment; If severe hearing impairment is measured or if significant neuropathy is reported at baseline the treating physician will discuss the risks for further permanent hearing loss and neuropathy with the patient. * Patients not able to have a MRI (due to pacemaker, claustrophobia, etc.). * Inability to return to MSKCC for frequent scheduled hydration sessions post-chemotherapy. * Inability to comply with requirements for cisplatin administration anti-emetic regimens post-treatment. * Patients not able or unwilling to travel for proton therapy.

Study Objectives Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia. Conditions: Advanced Malignancy, Cancer, Oncology, Oncology Patients, Acute Myeloid Leukemia Intervention / Treatment: DRUG: AMG 232, DRUG: Trametinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Men or women > 18 years old * Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy * Ability to take oral medications and willing to record daily adherance to investigational product * Adequate hematological, renal, hepatic, and coagulation laboratory assessments Exclusion Criteria: * Active infection requiring intravenous (IV) antibiotics * Prior participation in an investigational study (procedure or device) within 21 days of study day 1 * Major surgery within 28 days of study day 1 * Anti-tumor therapy within 14 days of study day 1

Study Objectives The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity. Conditions: Neoplasm Intervention / Treatment: DRUG: LY3023414 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed or for whom standard therapy would not be appropriate. * Have the presence of measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Have adequate organ and coagulation function. * Have discontinued all previous cancer therapies, and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days. * Are able to swallow capsules. * Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug. * Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug. * A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration. Exclusion Criteria * Have serious pre-existing medical conditions. * Have symptomatic central nervous system malignancy or metastasis. * Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and sponsor, may affect the interpretation of results. * Have a known active fungal, bacterial, and/or known viral infection. * Intolerance to any previous treatment with any phosphatidylinositol 3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) inhibitor. Treatment with any PI3K/AKT/mTOR inhibitor must have discontinued for at least 21 days or 5 half-lives prior to first study drug administration, whichever is shorter, and participants must have recovered from the acute effects of therapy. * Have a second primary malignancy that, in the judgment of the investigator, and sponsor may affect the interpretation of results. * Participants with active alcohol abuse, as determined by the investigator. * Have a history of heart failure according to New York Heart Association Class ≥3. * Have corrected QT (QTc) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG). * Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus. * Have any evidence of clinically active interstitial lung disease (ILD).

Study Objectives Although highly curable, cervical cancer kills thousands of women in developing countries annually. The investigators will pilot a project to improve detection of cervical cancer in Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise available in a large medical centre and remote use of a mobile phone camera application. Conditions: Uterine Cervical Neoplasms, Cervical Cancer Intervention / Treatment: OTHER: Cervical cancer screening Location: Tanzania Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Female * Over 18 years of age Exclusion Criteria: * Previous removal of uterus

Study Objectives This study aimed to investigate the effects of prostate cancer on patients' physical activity, kinesiophobia, fatigue and functionality. This research is a prospective study to be conducted on volunteer individuals between the ages of 40-75. People diagnosed with prostate cancer (study group) and healthy adults who have not been diagnosed with prostate cancer before (control group) will be included in the study. The demographic characteristics, physical activity levels and quality of life of all individuals participating in the study will be evaluated with an online form. In demographic data, physical, sociodemographic data such as age (years), height (cm), body weight (kg), body mass index (kg/m2) and disease-specific information will be recorded. Physical activity level will be measured with the International Physical Activity Survey short form (UFAA), fatigue with the Functional Evaluation of Chronic Disease Treatment-Fatigue Questionnaire, fear of movement with the Causes of Fear of Movement Questionnaire, and quality of life with the Functional Evaluation of Cancer Treatment-Prostate Version questionnaire (KHTFD-Y). Conditions: Prostate Cancer, Kinesiophobia, Physical Inactivity Intervention / Treatment: OTHER: survey evaluation Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * (for prostate cancer-study group) * Being between the ages of 40-75 * Want to participate in the study * Being able to read and write * Being diagnosed with prostate cancer by a specialist physician, * Being able to provide their mobility independently, * (for healthy controls - control group) * Being between the ages of 40-75 * Not having any previous cancer history and not having undergone cancer surgery * Volunteering to participate in the study Exclusion Criteria: * Those with a previously known or accompanying diagnosis of dementia * Not wanting to participate in the study * The individual has a disease that may prevent him or her from understanding and completing the survey. * Illiterates * Those who do not want to participate in the research voluntarily * Having active metastasis * Having undergone chemotherapy and radiotherapy in the last 6 months

Study Objectives The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk according to the quantity and functionality Conditions: Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies Intervention / Treatment: BIOLOGICAL: Recipients, BIOLOGICAL: Donors Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Criteria for adults: * Allogeneic HSCT with peripheral blood stem cell (PBSC) graft * Patients transplanted in cytologic Complete Remission (CR) * HLA 10/10 on HLA A, B, Cw, DRB1 and DQ molecules, from an intrafamilial or an unrelated donor * - Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity conditioning. Iv Busulfan doses between 6.4 mg/kg to 9.6 mg/kg or Fludarabine - TBI ≤ 8 Gy are accepted. ATG should be thymoglobuline at 5 mg/kg * Consent form signed by the patient * Consent form signed by the donor * Affiliated or beneficiary of a health insurance regimen * Criteria for pediatric patients: * Allogeneic HSCT with bone marrow grafts * Myeloablative conditioning (either TBI 12 Gy with Cyclophosphamide or iv Busulfan (12.8 mg/kg) and cyclophosphamide or Fludarabine - TBI > 8 Gy)- HLA 10/10 on HLA A, B, Cw, DRB1 and DQ molecules, from an intrafamilial or an unrelated donor * Consent form signed by the parents * Consent form signed by the donor or his legal representative if it is minor * Beneficiary of a health insurance regimen Exclusion Criteria: * History of previous autologous or allogeneic haematopoietic stem cell transplantation * Disease non in cytologic CR at transplant * Other type of conditioning than Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity. * Donor graft with any HLA mismatch including haploidentical and cord blood grafts * Graft having one or more mismatch with the recipient HLA

Study Objectives Primary Objective: 1. To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in patients with advanced cancer. Secondary Objectives: 1. To perform a preliminary assessment of the histone acetylation and DNA methylation effects of this combination on peripheral blood mononuclear cells (PBMC). 2. To assess the clinical anti-tumor activity (objective response including complete and partial responses) of this combination in patients with advanced cancer, in a descriptive fashion. Conditions: Advanced Cancers Intervention / Treatment: DRUG: Azacitidine, DRUG: Valproic Acid Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with pathologically confirmed malignancy that is metastatic or unresectable and refractory to standard therapy or for whom there is no standard therapy that induces complete remission (CR) of at least 10% or an increased survival of at least 3 months. * There is no maximum allowable number of prior chemotherapy regimens, provided all other eligibility criteria are met. * No chemotherapy, radiotherapy, investigational agents or surgery within four weeks. * ECOG performance status 2 or less. * Normal organ and marrow function - ANC > 1500/microL - Platelets > 100,000/microL - Total bilirubin < 2.0 mg/dL - Creatinine < 2.0 mg/dL * The effect of azacytidine on the development of human fetus is unknown. Because of the chemotherapy agents are known to be teratogenic, women and men of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of the study. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Uncontrolled concurrent illness such as neutropenic fever,shock, symptomatic congestive heart failure (NYHA class III or IV). * Hypersensitivity to divalproex sodium, valproic acid, or valproate sodium * Known or suspected hypersensitivity to azacitidine or mannitol. * Nursing and pregnant women. * Patients with urea cycle disorders (UCD): - History of unexplained coma, encephalopathy, or mental retardation - Encephalopathy associated with a protein load - Pregnancy-related or postpartum encephalopathy - History of elevated plasma ammonia or glutamine - Those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance. - Those with a family history of UCD or unexplained infant deaths (particularly males). * Patients with a known ornithine transcarbamylase disorder, history of unexplained coma or a family history of ornithine transcarbamylase disorder are excluded from this study. * Patients younger than 2-year old since valproic acid safety is not proven in this age group. * Leukemias and MDS are excluded

Study Objectives The purpose of this study is to evaluate whether the administration of allodepleted donor T cells to patients with haematological malignancies after stem cell transplant can improve the recovery of the patients immune system. Conditions: Haematological Malignancies Intervention / Treatment: BIOLOGICAL: CD25/71 allodepleted donor T-cells Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age ≥16 years * Underlying haematological malignancy * Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol * Written Informed consent Exclusion Criteria: * Life expectancy < 6 weeks * Female patients who are pregnant and lactating * Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT

Study Objectives This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals. Conditions: Non-Squamous Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: bevacizumab [Avastin], DRUG: cisplatin, DRUG: vinorelbine Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * patients >=18 years with locoregional advanced unresectable non-squamous NSCLC; * ECOG performance status of 0 or 1; * no prior thoracic head and neck irradiation or surgical resection for current lung cancer. Exclusion Criteria: * mixed, non-small cell and small cell tumors; * mixed adeno-squamous carcinomas with a predominant squamous component; * evidence of tumor invasion or encasement of major vessels; * history of grade >=2 hemoptysis; * presence of cavitations in lung lesions at baseline.

Study Objectives This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years. Conditions: Colorectal Cancer Location: Lebanon Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adult patients, age >=18 years * Proven metastatic colorectal carcinoma * Patients have measurable disease * Patients are eligible to receive first-line Avastin * Patients have signed data release form Exclusion Criteria: * Contra-indication to receive Avastin according to the local labeling * Participation in a clinical study within 30 days prior to enrolment * Patients have any other primary cancer * Concomitant treatment with other biologics * History of other malignant disease in the past 5 years except basal cell carcinoma

Study Objectives 1. purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG). 2. Experimental Design： Two-period crossover design 3. Test drug: imatinib mesylate capsule Reference drug: Glivec 4. Sample size：20 Conditions: Chronic Myeloid Leukemia Intervention / Treatment: DRUG: mesylate imatinib capsule, DRUG: Glivec Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Patients with chronic myeloid leukemia; * Age: 18-65 years,gender:both. * Weight: standard weight ± 20% within, and avoid weight disparity is too large; * No previous radiation therapy, chemotherapy, or surgery within 1 weeks before treatment with imatinib; * Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months; * No other malignancy; * Adequate hepatic, renal, and bone marrow function (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal, creatinine≤1.5×the institutional upper limit of normal); * Ability to understand objectives of the study, the study procedure, the pharmacological properties of the drug and possible adverse reactions and the willingness to sign a written informed consent. Exclusion Criteria: * Suffering from heart, liver, kidney disease or severe acute and chronic gastrointestinal diseases; * Pregnant or lactating women and be sensitive to drug; * Subjects are thought unsuitable for the study by investigators; * Inability to comply with protocol or study procedures in the opinion of the investigator; * Attending other clinical trials or attended other clinical trials 3 months ago.

Study Objectives Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%). Conditions: Bladder Cancer Location: Denmark Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients who previously had low grad NMIBC. * Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Exclusion Criteria: * Clinical suspicion of muscle invasive bladder cancer * Upper urinary track tumours * Patients undergoing neoadjuvant chemotherapy based on local protocols * Metastatic urothelial carcinoma * Patients recived installation therapy within the last 4 weeks

Study Objectives Empyema following pneumonectomy for Non Small Cell Lung Cancer (NSCLC) is a known problem that occurs in about 2% of pneumonectomy patients. Conditions: Non Small Cell Lung Cancer, Lung Cancer Location: Belgium Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Pneumonectomy for NSCLC Exclusion Criteria: * Pneumonectomy for other reasons (infectious pathology, trauma, mesothelioma, ...)

Study Objectives RATIONALE: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F18-EF5 to find oxygen and fludeoxyglucose F18 to find sugar in tumor cells may help in planning treatment for patients with non-small cell lung cancer. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: RADIATION: fludeoxyglucose F 18, RADIATION: Fluorine F 18 EF5, PROCEDURE: Positron emission tomography Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects must have a histologically confirmed NSCLC or clinical and imaging evidence of a de novo mass that is likely to be a NSCLC, stage I, II, or IIIA, for which surgery would be indicated for routine medical indications * ECOG performance status between 0 and 2 * Subjects must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits * WBC > 2,000/mm\^3 * Platelet count > 100,000/mm\^3 * Total bilirubin * Serum AST and ALT * Serum creatinine * Negative serum pregnancy test if a female of childbearing age Exclusion Criteria: * History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5 * Uncontrolled intercurrent illness that would limit compliance with study requirements * Pregnant women and women who are breastfeeding are excluded * Subjects who have been treated with neoadjuvant radiation or chemotherapy prior to their biopsy or excision are excluded because the impact of these therapies upon the degree of hypoxia of the tumor is unknown

Study Objectives This study plans to learn more about the use of Granulocyte Macrophage Colony Stimulation Factor (GM-CSF) on ependymoma tumors. The use of GM-CSF is a potential way of increasing the infiltration of immune cells and this study is looking at whether or not this will improve the outcome of patients with an ependymoma Conditions: Ependymoma, Recurrent Childhood, Ependymoma Intervention / Treatment: DRUG: Granulocyte Macrophage Colony Stimulation Factor Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age > 12 months and < 21 years at the time of study enrollment. * Patients must be one of the following: * Newly diagnosed with posterior fossa ependymoma with a subtotal resection at initial surgery. These patients will be eligible for stratum 1. * Be in first relapse of their posterior fossa ependymoma. These patients will be eligible for stratum 2. * Histologically confirmed diagnosis of intracranial ependymoma . * Pre or post-operative MR imaging of the brain demonstrates no evidence of non-contiguous spread beyond the primary site * Pre or post-operative MR imaging of the spine demonstrates no evidence of non-contiguous spread beyond the primary site * Pre-operative CSF cytology obtained from the lumbar CSF space demonstrated no evidence of non-contiguous spread beyond the primary site. * The requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated. * Patients must meet one of the following performance scores. * ECOG performance status scores of 0, 1, or 2. * Karnofsky score of ≥ 50 for patients > 16 years of age or Lansky score of ≥ 50 for patients ≤ 16 years of age * Organ Function Requirements: Adequate renal function defined as: * Creatinine clearance or radioisotope GFR ³ 70ml/min/1.73 m2 or * A serum creatinine based on age/gender as follows: Age Maximum Serum Creatinine (mg/dL) Male Female 1 month to < 6 months 0.4 0.4 6 months to < 1 year 0.5 0.5 1 to < 2 years 0.6 0.6 2 to < 6 years 0.8 0.8 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4 ≥ 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 liver function defined as: * Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and * SGOT (AST) or SGPT (ALT) < 3 x upper limit of normal (ULN) for age. * Patients with Gilbert syndrome or hemolytic anemia are eligible if total bilirubin is < 3 x upper limit of normal (ULN) for age. * Adequate Bone Marrow Function defined as: * Peripheral absolute neutrophil count (ANC) >= 1,000/uL * Platelet count >= 100,000/uL (transfusion independent). Exclusion Criteria: * Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, supratentorial ependymoma, or mixed glioma are NOT eligible. * Patients with evidence of metastatic disease by MRI or CSF cytology are NOT eligible

Study Objectives The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners. Participation of this study lasts for about for 16 weeks. Depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer. Eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer education program, PERC) groups. They complete baseline (T1, prior to randomization) and 4-month post-T1 follow-up measures (T2). Conditions: Prostate Cancer Intervention / Treatment: OTHER: Survivorship Care Plan, OTHER: Enhanced Survivorship Care Plan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: Eligibility included men who: * were diagnosed with localized PC; * were within 16 weeks of completing their initial curative intent treatment \[26\] at genitourinary and radiation oncology clinics at two comprehensive cancer centers in the U.S southeast; * were not treated for another cancer in last year; and * had a partner > 18 years of age not receiving cancer treatment. Exclusion Criteria: * Either member of couple unable to speak English * Unwilling/unable to provide Informed Consent

Study Objectives Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer. Conditions: Cervix Cancer Intervention / Treatment: DRUG: campto (irinotecan), DRUG: cisplatin (cisplatyl) Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically proven primitive epidermoid or andenocarcinoma Cervix * FIGO stage IIB (obviously parameter attack), III or IVA * No previous chemotherapy nor radiotherapy * Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma * PS ECOG < 2 * Life expectancy > 12 weeks * Written consent given Exclusion Criteria: * Other malignant cervix tumor histology * Visceral remotly metastasis * Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer * Anormal labs values * Peripheric neuropathy CTC > 2 * Auditory loss > 2 * Cardiopathy * Inflammatory digestive pathology * Evolutive infection * Other experimental concommitant treatment * Lacting or pregnant women

Study Objectives The purpose of this study is to check if lidocaine intravenous administration during surgery and 24 hours after surgery, associated with standardised management of the patient, helps to accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal neoplasms. Conditions: Colorectal Neoplasms Intervention / Treatment: DRUG: Lidocaine Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Colorectal neoplasm * Radical surgery * Median incision Exclusion Criteria: * American Society of Anesthesiologists (ASA) score equal to or up to 3 * Unwilling or unable to use patient-controlled analgesia (PCA) * Chronic consumption of opioids * Chronic drug or alcohol abuse * Chronic pain * Unable to read or write text * Inflammatory disease of intestinal tract * Allergy to morphine * Allergy to lidocaine * Severe atrioventricular conduction dysfunction without stimulator * Porphyry * Uncontrolled epilepsy * History of malign hyperthermia * Severe cardiac failure * Hepatic failure * Myasthenia * Treatment with beta blockers, antiarrhythmic calcium blockers, sultopride, nonselective monoamine oxidase inhibitor (MAOI) * Locoregional anaesthesia planned * Associated surgery concerning liver, pancreas, or gall bladder * Laparoscopic surgery * Severe psychiatric pathology * Refusal of the patient

Study Objectives This study is to assess how a theoretically guided mHealth communication informed by evidence of thoughts and affect about colorectal cancer can enhance how an existing mHealth (cell/mobile based text messaging health promotion) intervention increased physical activity in healthy adults. Conditions: Colorectal Cancer, Sedentary Lifestyle Intervention / Treatment: BEHAVIORAL: Common-Sense Model (CSM) Be Well, BEHAVIORAL: ACS usual messages, BEHAVIORAL: NCI HealthyYouTXT--Get Active (HYT--GA) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Open to all interested who are 18 years of age and older, all genders, all ethnic and/or racial identities, and regardless of health status. * Capacity to engage in physical active without medical and/or assisted supervision. During screening, this will be assessed by the Physical Activity Readiness (PAR-Q) survey. It confirms capacity to engage in physical activity that does not need to be medically/professionally supervised. * Has interest and ability to receive Short Message Service (SMS) text messages linked to a cell phone and access to the internet for information that is web based. * Individuals who report light/moderate physically active and sedentary lifestyles (<6.0 METs). METs are the metabolic equivalents that measures the energy related to physical activity and/or sedentary behavior. * Interest in wearing a pedometer. Exclusion Criteria: * Reports of vigorous levels of physical activity. Specifically, those who report >6.0 METs. METs are the metabolic equivalents that measures the energy related to physical activity and/or sedentary behavior. * Those who report that a medical doctor has recommended anytime with the last 12 months that there be limited physical activity due to heart disease, pain, physical ailments, dizziness, loss of consciousness, bone/joint problems related to engaging in physical activity. * Those who report that a doctor recommended against engaging in supervised physical activity and/or moderate physical activity (such as walking, riding a bicycle, or mowing the lawn).

Study Objectives The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon. Thus, the primary objective of this study is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC). Conditions: Prostate Cancer Intervention / Treatment: DRUG: tasquinimod, DRUG: tasquinimod 0.25 mg; 0.5 mg, DRUG: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features; * At least 18 years of age when signing the Informed Consent; * Presence of metastatic disease on bone scan or CT/MRI imaging; * Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration); * For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial; * Serum testosterone level < 50 ng/dL at the Screening Visit; * Progressive disease on or following docetaxel-based chemotherapy with medical or surgical castration. Patients who are intolerant of docetaxel are also allowed. Disease progression for study entry is defined as one or more of the following three criteria: 1) PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL); 2) Soft tissue disease progression defined by RECIST 1.1; 3) Bone metastatic disease progression defined by one or more new lesions on bone scan that are not clinically consistent with tumor flare; * No more than three prior chemotherapy regimens with at least one regimen containing docetaxel (unless intolerant as per # 7 above); * Karnofsky Performance Status of >70; * Estimated life expectancy of at least three months; * Able to swallow the study drug and comply with study requirements; * Willing and able to give informed consent. Exclusion Criteria: * Subjects > 80 years old (dose escalation phase only, due to lower clearance in elderly patients); * Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment; * Metastases in the brain or active epidural disease (NOTE: patients with treated epidural disease are allowed provided follow up imaging documents stability of epidural disease); * Absolute neutrophil count < 1,200/μL, platelet count < 100,000/μL, and hemoglobin <9 g/dL at the Screening Visit; (NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the Screening Visit) * Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal at the Screening Visit; * Creatinine > 1.5 x ULN at the Screening visit; * History of another malignancy within the previous 3 years other than non-melanomatous skin cancer or non-invasive bladder cancer treated with curative intent; * Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide, MDV3100), 5-α reductase inhibitors (finasteride, dutasteride), estrogens (ie DES), sipuleucel-T, or chemotherapy within 28 days of 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 or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of Day 1 visit; * Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 * Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 28 days prior to Day 1 Visit. For abiraterone acetate or TAK700, 14 days washout is needed. * Ongoing treatment with sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic range (Appendix 3). * Ongoing treatment with CYP3A4 substrates with narrow therapeutic range (Appendix 3). * Radiation therapy within 2 weeks (if single fraction of radiotherapy within 2 weeks) and radionuclide therapy within 8 weeks of Day 1 visit; * Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery; * Structurally unstable bone lesions suggesting impending fracture; * Clinically significant cardiovascular disease including:myocardial infarction within 6 months, uncontrolled angina within 3 months, congestive heart failure, Diagnosed or suspected congenital long QT syndrome; significant ventricular arrhythmias, Prolonged corrected QT interval by the Fridericia or Bazett correction formula, History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; Hypotension (systolic blood pressure < 86 mMHg or bradycardia with a heart rate < 50 beats per minute on any ECG taken at the Screening or Day 1 visit; Uncontrolled hypertension; TIA or stroke/CVA within 6 months of Day 1 visit; Rest limb claudication or ischemia within 6 months of Day 1 visit * Use of an investigational agent within four weeks of Day 1 visit or plans to initiate treatment with an investigational agent during the study; * Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months); * Major surgery within four weeks prior to Day 1 visit. * Presence of NCI CTC grade >1 peripheral neuropathy * History of pancreatitis * Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host). * Chronic hepatitis B or C with advanced, decompensated hepatic disease, or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study). * Documented prior disease progression on tasquinimod -

Study Objectives Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study, the investigators propose an evaluation of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer. Conditions: Metastatic Breast Cancer Intervention / Treatment: DRUG: Amrubicin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Females >=18 years of age. * Histologic diagnosis of HER2-negative breast cancer. HER-2 negativity must be confirmed by one of the following: * FISH-negative (FISH ratio <2.2), or * IHC 0-1+, or * IHC 2-3+ AND FISH-negative (FISH ratio <2.2) * Evidence of metastatic or locally advanced, inoperable breast cancer. * Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens. * Patients with prior anthracycline therapy are eligible, provided their previous anthracycline was ≥6 months prior to study entry. * Measurable disease per RECIST criteria version 1.1 * Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA). * Patients must have QTc interval of <=450 msec. * No intercurrent significant medical conditions or cardiac illness. * Patients must be >=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2. * Adequate organ function including the following: * ANC >=1500 cells/mL * Platelet count >=100,000 cells/mL * Hemoglobin >=9 g/dL * Total bilirubin <=1.5 x ULN; AST/ALT <=2.5 x ULN, (except if due to hepatic metastases, then <=5 x ULN) * Serum creatinine <1.5 x ULN * Women of childbearing potential must have a negative serum or urine pregnancy test performed <=7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. * Patients must be accessible for treatment and follow-up. * Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry. * Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable. Additionally, the patient's INR must be adequate if the patient is receiving treatment with coumadin. * Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient's enrollment in this study. Exclusion Criteria: * Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy. * Prior treatment with >=3 regimens of cytotoxic therapy in the advanced disease setting. (Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient's enrollment into this study). * Major surgery or systemic therapy <=3 weeks of study treatment. * Prior high-dose chemotherapy requiring hematopoietic stem cell support. * Prior radiation therapy to >25% of the bone marrow. * Uncontrolled brain metastases. Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at >=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued. * Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis. * Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ \[DCIS\], or lobular carcinoma in situ \[LCIS\]). * Any of the following <=12 months prior to starting study treatment: * myocardial infarction; * severe unstable angina; * congestive heart failure; * ongoing cardiac dysrhythmia. * Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia. * Patients with previous allergy or hypersensitivity to anthracyclines. * Patients who have had a ≥10% drop in LVEF on previous anthracycline therapy. * Palliative radiotherapy to areas of metastatic breast cancer must have been completed >7 days prior to the first dose of study treatment. The exception is radiotherapy for brain metastases, which must be completed >=21 days prior to study treatment. (Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion). * Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. * History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications. * Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study. * Use of any non-approved or investigational agent <=30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.

Study Objectives To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer Conditions: Breast Cancer Metastatic Intervention / Treatment: DRUG: Irinotecan plus capecitabine Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologic or cytologic diagnosis of breast cancer Stage IV or recurrent. * Previous chemotherapy with anthracyclines and taxane in adjuvant setting * Previous hormonal therapy in adjuvant and metastatic setting is allowed * Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease. * No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study. * Performance status of 0, 1, 2 on the ECOG criteria. * Clinically measurable disease, defined as uni-dimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1 cm, as defined by x-ray, CT scan, MRI, or physical examination. * Estimated life expectancy of at least 12 weeks. * Patient compliance that allow adequate follow-up. * Adequate hematologic (WBC count ³ 3,000/mm3, platelet count ³ 100,000/mm3), hepatic (bilirubin level £ 1.5 mg/dL), and renal (creatinine concentration £ 1.5 mg/dL) function. * Informed consent from patient or patient's relative. * Males or females at least 18 years of age. * If female: childbearing women should use non-hormonal contraceptive method Exclusion Criteria: * MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia. * Serious concomitant infection. * Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).

Study Objectives This phase II trial studies how well dasatinib works in treating patients with head and neck cancer that has come back or spread to other areas of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer Intervention / Treatment: DRUG: dasatinib, PROCEDURE: pharmacological study, PROCEDURE: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient has histologically proven squamous cell carcinoma of the head and neck that is recurrent after surgery and/or radiation therapy or chemoradiation therapy or is metastatic and disease must be measurable by RECIST criteria * Patients must have measurable disease as defined by RECIST criteria * Patients have received =< 1 prior chemotherapeutic regimen for recurrent or metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Hemoglobin (Hgb) >= 9.0 g/dL * Total bilirubin =< 1.5 X upper limit of normal * Albumin >= 2.5 g/dL * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 1.5 X upper limit of normal * Creatinine =< 3 mg/dl * Paraffin embedded tumor tissue that is appropriate for immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH) analysis must be available or patient must be amenable to biopsy to obtain tissue for the study * Ability to understand and the willingness to sign a written informed consent document * Patient must not be pregnant or breastfeeding; all sexually active females of child-bearing potential and all sexually active males with sexual partners of child-bearing potential should practice contraception (e.g. barrier, hormonal, intrauterine device \[IUD\]) or sexual abstinence while in the study and for two months following completion of therapy * Brain metastases permitted provided the patient does not require anticonvulsants or corticosteroids, or has been off them at least 7 days; patients with brain metastases must be either > 4 weeks beyond cranial irradiation or must be felt not to require it at that time * The patient's O2 saturation must be >= 92% on room air Exclusion Criteria: * Chemotherapy or palliative radiotherapy for recurrent and/or metastatic disease within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier; concomitant chemoradiation therapy within 6 weeks prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier * Other anti-neoplastic agents, i.e., cytotoxic chemotherapy, immunotherapy, radiotherapy or investigational therapy, used to treat the primary disease will not be allowed during the study; local radiation (excluding radiotherapy to the target lesion) for supportive reasons involving a small radiation field may be allowed * Patient has a history of uncontrolled or severe medical disease which could compromise participation in the study such as uncontrolled diabetes (fasting blood glucose > 200 mg/dl), uncontrolled hypertension (systolic blood pressure \[BP\] > 160 or diastolic BP > 100 mmHg), severe infection (bacterial infection requiring intravenous \[IV\] antibiotics or human immunodeficiency virus \[HIV\]), angina at rest, congestive heart failure New York Heart Association (NYHA) class III or IV, ventricular arrhythmias requiring therapy, myocardial infarction within 6 months, > grade 2 neuropathy * Patients may not be receiving any other investigational agents * Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; efforts should be made to switch patients with gliomas or brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications * Echocardiogram less than institutional normal measured by echocardiogram for subjects with history of congestive heart failure, symptoms of congestive heart failure, clinical evidence suggesting impaired cardiac function * Patients may not have any clinically significant cardiovascular disease including the following: * Myocardial infarction or ventricular tachyarrhythmia within 6 months * Prolonged correct QT interval (QTc) > 480 msec (Fridericia correction) * Major conduction abnormality (unless a cardiac pacemaker is present) * Pregnant women and women who are currently breast-feeding may not participate in this study; all women of childbearing potential must have a negative pregnancy test within 72 hours prior to enrolling in the study; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential * Patients having pleural effusion

Study Objectives The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer. Conditions: Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity Intervention / Treatment: DRUG: docetaxel, DRUG: cisplatin, DRUG: hydroxyurea, DRUG: fluorouracil, PROCEDURE: chemotherapy, PROCEDURE: radiotherapy Location: Spain, United States, Russian Federation, France, Croatia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age 18 years or older * Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck (excluding lip), or lymphoepithelioma * No prior chemotherapy or radiotherapy * Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor * Karnofsky performance status of >= 70% * Intact organ and bone marrow function * Obtained informed consent Exclusion Criteria: * Demonstration of metastatic disease (i.e. M1 disease). * Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea * Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years. * Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment. * Incomplete healing from previous surgery * Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician. * Uncontrolled active infection unless curable with treatment of their cancer.

Study Objectives The purpose of this study it so compare the safety and efficacy profiles of a generic imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of actinic keratosis (AK). Conditions: Actinic Keratosis Intervention / Treatment: DRUG: Imiquimod, DRUG: Zyclara®, DRUG: Vehicle Cream Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Participant is a male or female, 18 years of age or older. * Participant has provided written informed consent. * Participant is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study. * Participant has a clinical diagnosis of AK with at least 5 and no more than 20 clinically typical, visible or palpable AK lesions, each at least 4 millimeters (mm) in diameter, in an area greater than 25 cm\^2 on the face (excluding ears) or balding scalp, but not both. * Participant is in good general health and free of any disease state or physical condition that might impair evaluation of AK lesions or which, in the investigator's opinion, exposes the participant to an unacceptable risk by study participation. * Females must be post-menopausal, surgically sterile or use an effective method of birth control, with a negative urine pregnancy test (UPT) at the Baseline visit. Exclusion Criteria: * Participant is pregnant, lactating, or is planning to become pregnant during the study. * Participant has hyperkeratotic, hypertrophic or atypical AKs (for example, AK greater than \[>\] 1 cm\^2 in size) in the treatment area. * Participant is currently enrolled in an investigational drug or device study. * Participant plans to be exposed to artificial tanning devices or excessive sunlight during the trial. * Participant is immunosuppressed (for example; human immunodeficiency virus \[HIV\], systemic malignancy, graft vs. host disease, etc.). * Participant has experienced an unsuccessful outcome from previous imiquimod therapy (an unsuccessful outcome is defined as after a reasonable therapeutic trial with no compliance issues and the topical drug do not work). * Participant has used an investigational drug or investigational device within 30 days prior to the Baseline visit. * Participant has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, UVB therapy, chemical peels or dermabrasion on the face or balding scalp within 6 months prior to the Baseline visit. * Participant has cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision or other treatments for AK on the designated treatment area (face or scalp) within 1 month prior to the Baseline visit. * Participant has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies or retinoids within 1 month prior to the Baseline visit. * Participant has used topical medications; corticosteroids, alpha hydroxyl acids (for example; glycolic acid, lactic acid etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate or prescription retinoids (for example; tazarotene, adapalene, tretinoin) to the face or balding scalp within one month prior to the Baseline visit. * Participant has used topical creams, lotions or gels of any kind to the selected treatment area within one day prior to the Baseline visit. * Participant has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or scalp). * Participant has a history of sensitivity to any of the ingredients in the test articles. * Participant has any skin pathology or condition (for example; facial/scalp psoriasis, atopic dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could interfere with the evaluation of the test article, worsen due to the treatment or requires the use of interfering topical, systemic or surgical therapy. * Participant has any condition which, in the investigator's opinion, would make it unsafe or precludes the participant's ability to fully participate in this research study. * Participant is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (for example; due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Study Objectives Study title: An exploratory, randomised, double-blind, placebo controlled crossover study to assess the efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms. Study code: SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to § 40 Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Monitoring Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Clinical phase Phase II Primary objective: Reduction of wheal and flare type skin reaction after standardised provocation testing assessed by volumetric and thermographic measurements. Secondary objectives: Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as assessed by symptom score, DLQI, Itchy-QoL and VAS. Study design: An exploratory, randomised, double-blind, placebo controlled crossover study Type and number of patients: Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic mastocytosis with skin involvement Main criteria for inclusion: Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid or other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode of administration 20 mg Rupatadine or placebo before provocation testing, oral administration (tablets) Duration of treatment: 28 days (testing will be done at the day of last treatment) Assessment of efficacy: 1. Assessment of wheal and flare development by planimetric analyses of digital photographic, volumetric, and thermographic imaging (time lapse) before and after treatment with study medication, 2. Additional assessment of symptoms, 3. Assessment of life quality Main criteria of evaluation: Efficacy Conditions: Mastocytosis Intervention / Treatment: DRUG: Rupatadin Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: QUADRUPLE

Inclusion Criteria: * Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign * Age between 18 and 65 years. * Female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised. * Voluntarily signed written informed consent. Exclusion Criteria: * The presence of permanent severe diseases, especially those affecting the immune system, except for mastocytosis * History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia * History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper-/hypokalemia, bradycardia < 50bpm, QTc interval > 440ms * Evidence of severe renal dysfunction (creatinine > 1,5 x upper reference value) * Evidence of significant hepatic disease (liver enzymes > 2 x upper reference value) * History of adverse reactions to RUP, or other ingredients of the IMP * Presence of active cancer which requires chemotherapy or radiation therapy * Aggressive systemic mastocytosis * History or presence of alcohol abuse or drug addiction * Participation in any clinical trial within 4 weeks prior to enrolment * Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG * Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study * Intake of oral corticosteroids within 14 days prior to the beginning of the study * Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study * Pregnancy or breast-feeding

Study Objectives This is a multicentre; single arm study in subjects with newly diagnosed multiple myeloma. The primary objectives of this study is to assess the effect of bortezomib combination therapy (PAD regimen) followed by ASCT on bone metabolites in patients with newly diagnosed multiple myeloma, as measured by ELISA methodology as previously described analyzing the change in biochemical bone marker compared with the baseline value: bone formation marker- bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）. The secondary objectives of this study are: 1. Subgroup analysis for the change from baseline in biochemical bone marker based on whether or not Bisphosphonate was used. 2. Assessment of other bone markers parameters: bone formation marker -carboxy terminal propeptide of type I procollagen (PICP); bone resorption markers -carboxy terminal telopeptide region of type I collagen ( ICTP); osteoclast stimulators -osteoprotegerin(OPG), soluble receptor activator of nuclear factor kappaB ligand(sRANKL); 3. To observe the effect of bortezomib on bone mineral density (BMD) as measured by repeated quantitative CT-scan; 4. The evaluation of Skeletal related events (SRE) and appearance of new bone lesions; 5. To determine progression free survival (PFS), 1 year survival, overall survival and safety profile following treatment with PAD and ASCT as first-line therapy. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: PAD Followed by ASCT Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Man or woman aged 18 to 65 years old; * Subjects are newly diagnosed MM patients which are scheduled by the investigators to be treated with vincristine, adriamycin and dexamethasone standard therapy. Stage II/III (according to Durie and Salmon criteria) with skeletal involvement, such as bone pain, bone lytic lesions, diffuse osteoporosis or pathologic fractures; * Life expectancy > 3 months; * Patient has measurable disease in which to capture response, defined as one or more of the following; * Serum M-protein level >10.0 g/L measured by serum protein electrophoresis or immunoglobulin electrophoresis; or * Urinary M-protein excretion > 1 g/24 hours; or * Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or * Serum free light chains (by the Freelite test) > 2 X the upper limit of normal (ULN), in the absence of renal failure. * Performance status (PS) of ECOG ≤2.0, unless PS of 3-4 based solely on bone pain; * Patients must have a Platelets count≥50×109 cells /L; Absolute neutrophil count (ANC)≥0.75×109 cells /L; * Patients must have adequate hepatic function defined as Alanine transaminase(ALT) ≤ 2.5 × upper limit of normal(ULN); Aspartate transaminase (AST) ≤2.5×ULN; Total bilirubin ≤2×ULN; * Patients must have adequate renal function defined as creatinine clearance >30 ml /min; * Subjects (or their legally acceptable representatives) must have signed a informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria: * Non-secretory MM, unless the patient has measurable lesions on computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET); * Peripheral neuropathy or neuropathy pain grade 2 or high as defined by National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE) Version 3; * Uncontrolled or severe cardiovascular disease, including myocardial infarction (MI ) within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis; * History of allergy reaction attributable to compounds containing boron or mannitol; * Any serious, active disease or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or the investigator's decision; * Concurrent treatment with another investigational agent; * Female subject who is pregnant or breast-feeding.

Study Objectives Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU. The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed. Conditions: Neoplasms Intervention / Treatment: DRUG: BIBW 2992, DRUG: BIBW 2992 Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Masking: NONE

Inclusion criteria: * Patients with histologically or cytologically confirmed diagnosis of non resectable and / or metastatic cancer, preferably squamous cell carcinomas of head and neck, oesophagus, lung or cervix * Indication for a standard treatment with either cisplatin plus paclitaxel or cisplatin plus 5 FU as judged by the investigator * Age 18 years or older. * Life expectancy of at least three (3) months. * Written informed consent that is consistent with ICH-GCP guidelines. * Eastern Cooperative Oncology Group (ECOG) performance score less or equal 2. * Patients must have recovered from any therapy-related toxicity from previous chemo-, hormone-, immuno-, or radiotherapies. * Patients recovered from previous surgery. Exclusion criteria: * Active infectious disease. * Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea. * Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol. * Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least four (4) weeks, no history of cerebral oedema or bleeding in the past four (4) weeks and no requirement for steroids or anti-epileptic therapy. * Cardiac left ventricular function with resting ejection fraction less than 50% * Absolute neutrophil count (ANC) less than 1500 / mm3. * Platelets count less than 100 000/mm3. * Bilirubin more than 1.5 x upper limit of institutional norm. * Aspartate amino transferase (AST) or alanine amino transferase (ALT) more than 3 x upper limit of institutional norm. * Serum creatinine more than 1.5 x upper limit of institutional norm. * Women and men sexually active and unwilling to use a medically acceptable method of contraception. * Pregnancy or breast-feeding. * Treatment with other investigational drugs; chemotherapy, immunotherapy, or radiotherapy or participation in another clinical study with anti-cancer therapy within the past 4 weeks before start of therapy or concomitantly with this study. * Treatment with an EGFR- or HER2 inhibiting drug within the past four weeks before start of therapy or concomitantly with this study (2 weeks for trastuzumab). * Patients unable to comply with the protocol. * Active alcohol or drug abuse.

Study Objectives Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. The investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection. Conditions: Thyroid Carcinoma, Thyroidectomy Intervention / Treatment: DRUG: Usage of Fibrin sealant, PROCEDURE: Thyroidectomy Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * proven thyroid carcinoma * Thyroidectomy with anterior compartment neck dissection Exclusion Criteria: * No use of harmonic scalpel during surgery * coagulation abnormality * refuse to participate

Study Objectives Percutaneous sclerotherapy is currently a widely used treatment for subcutaneous low-flow vascular malformations. Considered as a low-flow vascular malformation, symptomatic liver hemangiomas could also theoretically be safely and effectively treated by percutaneous sclerotherapy with a mixture of Bleomycin and Lipiodol. The safety and efficacy of percutaneous sclerotherapy was firstly introduced by the investigator's investigators in 5 patients in a pilot study. The aim of this study is to design and conduct a study to evaluate the safety and efficacy of percutaneous sclerotherapy in a larger sample size with a long term follow-up. Conditions: Hemangioma Liver Intervention / Treatment: PROCEDURE: sclerotherapy arm Location: Iran, Islamic Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * patients with symptomatic liver hemangioma Exclusion Criteria: * hepatic or renal impairment * abdominal symptoms unrelated to a liver mass * uncorrectable coagulopathy * lung fibrosis * allergy to contrast media * systemic infection * liver abscess * biliary obstruction

Study Objectives This study is a randomized controlled trial comparing Laparoscopic and endoscopic drainage for pseudocyst of the pancreas secondary to acute pancreatitis. The primary outcome measure will be resolution of the pseudocyst by the intended treatment within 4 weeks. The secondary outcomes will be complications, recurrence and cost analysis between the two methods. Conditions: Pancreatic Pseudocyst Intervention / Treatment: PROCEDURE: Laparoscopic cystogastrostomy, PROCEDURE: Endoscopic cystogastrostomy Location: India Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: Symptomatic patients with pseudocyst of size more than 6 cm, more than 6-8 weeks duration after an attack of acute pancreatitis. Exclusion Criteria: * Patients with chronic pancreatitis associated pseudocyst. * Patients who have undergone any form of intervention previously * Patients with significant co-morbidities * Patients unfit for general anesthesia * Bleeding disorders * Patients refusing consent * Patients having significant necrotic debris not considered fit for endoscopic drainage. The presence of necrotic debris will be assessed by ultrasound of the abdomen and if required magnetic resonance imaging. The volume of the cyst and that of necrotic debris will be calculated and significant debris will be defined as >30% of debris volume/volume * Presence of a pseudoaneurysm

Study Objectives The purpose of this study is to determine whether or not CTCs can be detected in blood samples taken from patients diagnosed with small cell lung cancer. The purpose is to compare CTC analysis to tumor samples to look for differences. Conditions: Small Cell Lung Cancer Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Histological proof of small cell lung cancer with extensive stage disease and have been untreated. * Must be willing to give and sign informed consent. * Must be 18 years of age Exclusion Criteria: * Less than 18 years of age.

Study Objectives The purpose of the research is to examine the usefulness of using patient navigators in improving coordination of care between the Breast Examination Center in Harlem (BECH) and the Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) for patients with a suspicious breast finding. This study will collect information to improve the role of the Patient Navigator, nonmedical staff that helps coordinate patient care. The study will also collect information to be used to help remove barriers that happen when several different institutions provide care. Conditions: Breast Cancer Intervention / Treatment: OTHER: Patient Navigation Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women with a suspicious screening finding * Referred from Breast Examination Center of Harlem (BECH) Exclusion Criteria: * Women that were not initially seen at Breast Examination Center of Harlem (BECH) * Women with normal breast screening findings

Study Objectives Multiple myeloma (MM), a plasma cell disorder, is the second most common hematologic malignancy in the U.S. No standard curative therapy has yet been found. A variety of therapeutic measures including high dose melphalan, induction therapy, and continuous therapy have been used but the goal of complete response without relapse has not been achieved. More active treatment regimens and better tools for response assessment are needed. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: KRdD followed by auto-HCT, DRUG: KRdD only Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Age >18 years with no upper age limit * Diagnosis of newly diagnosed multiple myeloma with indication for initiation of therapy. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m2) and/or cyclophosphamide up to 1000 mg/m2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than 4 weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available. * Measurable disease meeting at least one of the following criteria: 1. Serum monoclonal (M) protein ≥1.0 g/dl 2. ≥ 200 mg of M protein/24h in the urine 3. Serum-free light chain ≥10 mg/dL and abnormal kappa to lambda ratio. * Life expectancy ≥12 months. * Adequate hepatic function, with serum ALT ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 μmol/L) within 21 days prior to initiation of therapy. * Creatinine clearance (CrCl) ≥ 40 mL/minute within 21 days prior to start of therapy either measured or calculated using a standard formula (eg. Cockcroft and Gault). * Written informed consent in accordance with federal, local, and institutional guidelines. * Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception. Male subjects must agree to practice contraception. * All subjects must agree to comply with and be enrolled in Revlimid REMS program. Exclusion Criteria: * Diagnosis of amyloidosis, Crow-Fukase syndrome, Waldenstrom's macroglobulinemia, smoldering MM. * Major surgery, radiotherapy or infection requiring therapy within 14 days of starting treatment. * Known FEV1 or cDLCO < 50% of predicted. * Pregnant or lactating females. * Known human immunodeficiency virus infection. * Active hepatitis B (Hepatitis B core antibody positive and subsequent Hepatitis B surface antigen positive or Hepatitis B DNA positive) or C infection (Hepatitis C antibody positive and subsequent detectable viral load). * Unstable angina or myocardial infarction within 4 months prior to registration, New York Heart Association Class II, III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker. * Cerebrovascular disease manifested as prior stroke at any time or TIA in the 12 months prior to initiation of therapy * Non-hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or localized thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas. * Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 21 days prior to registration. * Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib). * Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 21 days prior to registration. * Contraindication or intolerance to required supportive care medications (Aspirin and Acyclovir). * Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.

Study Objectives This research study is a Phase II clinical trial. In addition to studying safety, Phase II clinical trials test if the investigational drug is effective and whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved CRLX101 for your type of cancer. Camptothecin is a chemical extracted from plants that is the basis for the standard FDA-approved chemotherapy drugs irinotecan and topotecan. Camptothecin works by interfering with the way cells divide and multiply. The investigational drug CRLX101 is a formulation of camptothecin and a large molecule (nanoparticle)that appears to allow more of the camptothecin to get into tumors and stay in tumors. The persistence of the CRLX101 in the tumor may increase the probability that the tumor cells will be damaged. CRLX101 has been well tolerated in the laboratory and in participants with different kinds of cancer. Bevacizumab (Avastin) is a VEGF inhibitor which has activity in many kinds of cancer. Bevacizumab has been successfully combined with many chemotherapy partners. It has been hypothesized that the combination of bevacizumab with CRLX101 might have unique clinical activity in combination in the treatment of this disease due to the simultaneous inhibition of distinct steps along the HIF → (CAIX) → VEGF → VEGFR2 pathway. Specifically, it is hypothesized that CRLX101-mediated inhibition of HIF-1α carries with it the potential to interrupt hypoxia and HIF-1α-associated resistance to VEGFR inhibitors. It is hoped that this combination will work to treat your type of cancer. Conditions: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer Intervention / Treatment: DRUG: CRLX101 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed epithelial ovarian, tubal or primary peritoneal cancer * Measurable disease * May have received up to 2 prior cytotoxic chemotherapy * Life expectancy of greater than 3 months Exclusion Criteria: * Pregnant or breastfeeding * Prior camptothecin, prior VEFG inhibitors * Gross hematuria * Chemotherapy or radiotherapy within 4 weeks of study entry * uncontrolled HTN * Receiving other study agents * History of allergic reaction to compounds of similar chemical or biologic composition to topotecan or irinotecan * Known brain metastases * History of a different malignancy within the previous 2 years * Intercurrent illness * HIV positive on combination antiretroviral therapy

Study Objectives The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials \[neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005\]. Conditions: Platelet-Derived Growth Factor, Diabetic Foot, Neoplasms Intervention / Treatment: DRUG: Sterile becaplermin gel vs. sterile placebo gel treatment 1 Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients are required to satisfy the following criteria before entering the study: given written informed consent before the performance of any study-related procedures, if deceased, the cause of death, if known, is collected by the investigator (where permitted by the local authorities) * Received at least 1 dose of study medication in 1 of the double-blind trials PDGF-DBFT-003 or PDGF-DBFT-005 and had any post-baseline data * A minimum of 12 months elapsed since last study drug dosing in 1 of the double-blind trials PDGF-DBFT-003 or PDGF-DBFT-005 Exclusion Criteria: * Patients who meet any of the following criteria are excluded from participating in the study: Patients who are unwilling to participate * Patients who, despite multiple and documented efforts, could not be contacted (the investigator was asked to try at least 3 times to contact the patient or patient's representative or parents by mail and phone)

Study Objectives The investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic Lymphocytic Leukemia (CLL) cells will predict a more aggressive clinical course. The results from this proposal will validate the use of a novel antibody developed at Dartmouth-Hitchcock in CLL and will predict CLL patients that have a more aggressive form of the disease. The investigators work will also provide direct evidence that LPL is expressed on CLL cells and provides a critical source of fatty acids required by the CLL cells to grow and survive. Fatty acid metabolism may become a therapeutic target in CLL in the future. Conditions: Chronic Lymphocytic Leukemia Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Diagnosis of CLL as per National Cancer Institute Working Group Guidelines * Patients undergoing routine blood draws as part of their ongoing follow up for CLL * 18 years or older * Ability to provide consent in English * Patient must have measurable disease as defined by an absolute lymphocyte count greater than 5,000/mm3 or have archived lymph node or bone marrow with CLL involvement. Exclusion Criteria: * Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their CLL, * other hematologic malignancy or other disease process within the past 6 months are excluded.

Study Objectives The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. It has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis. The present study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability. It will be assessed using a scratch assay, Mtt assay and ATP analysis. Conditions: Osteosarcoma Intervention / Treatment: DEVICE: Extracorporeal shockwave device, DEVICE: No ESWT Location: India Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Cell cultures with a confluency of 70%-80% Exclusion Criteria: * Contaminated cell cultures

Study Objectives This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™. Conditions: Human Papillomavirus Infection Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: 3-Dose Safety Population * Female 9-26 years at the time of first dose of GARDASIL™ * Completed the 3-dose regimen of GARDASIL™ per protocol Pregnancy Safety Population * Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution Autoimmune Safety Population * Female who has received at least one dose of GARDASIL™ * Has been a member of same Managed Care Organization (MCO) for at least 12 months prior to the receipt of GARDASIL™ Any Dose Safety Population * Female who has received at least one dose of GARDASIL™ Exclusion Criteria: 3-Dose Safety Population * Male * Receives incomplete regimen of GARDASIL™ * Completes the three dose regimen of GARDASIL™ in more than 12 months * Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3 * Younger than 9 or older than 26 years of age at receipt of first dose Pregnancy Safety Population * Males * No record of pregnancy at the Managed Care Organization (MCO) Autoimmune Safety Population * Member of the same MCO for less than 12 months prior to receiving the first dose * Male

Study Objectives The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' understanding of melanoma. Conditions: Melanoma, Malignant Melanoma Intervention / Treatment: OTHER: Patient Educational Materials Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * 18 years of age or older at time of consent, may be men or women. * Able to adhere to the study visit schedule and other protocol requirements. * Capable of giving informed consent. Exclusion Criteria: * Non-English speaking individuals.

Study Objectives This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years. Conditions: Cervical Intraepithelial Neoplasia Intervention / Treatment: DRUG: Placebo, DRUG: RO5217790 Location: Spain, United States, France, Belgium, Puerto Rico, Finland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Have a diagnosis within 2 months prior to the first dose of RO5217790 of CIN 2/3 confirmed by colposcopy-directed punch biopsy; patients must have at least 1 quadrant of residual CIN2/3 disease remaining after biopsy. Entry to the trial will be allowed based on the local assessment of this criterion; however, CIN 2/3 diagnosis will have to be confirmed by the central pathologist for the purposes of analyzing the study * Have satisfactory colposcopy, i.e. the entire acetowhite or disease area as well as the entire squamocolumnar junction visualized by colposcopy * Have detection at screening of a single or multiple HR-HPV infection by analysis of liquid based cytology (LBC) material on the Roche Linear Array assay consistent with any of the trial strata as specified in study protocol Exclusion Criteria: * Have colposcopically visible CIN2/3 disease extending over more than 2 quadrants * Have any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the transformation zone and surveillance of CIN. If an endocervical curettage (ECC) is performed, and the endocervical curettings reveal CIN, patients are eligible as long as the endocervical lesion is directly extending from the primary lesion and is colposcopically visible in its entirety * Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia * Have atypical endometrial or glandular cells or evidence of carcinoma on biopsy * Have a serious, concomitant disorder, including active systemic infection requiring treatment * Have a prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma), unless the history of skin cancer is at the site of study treatment administration * Have a proven or suspected immunosuppressive disorder or autoimmune disease * Have any significant cardiac, hepatic or renal disease * Have active viral infections including human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), cytomegalovirus (CMV), and Epstein barr virus (EBV) within 30 days of receiving study treatment. Mild viral infections such as Herpes Simplex Virus 1 (HSV-1) or common cold are not excluded

Study Objectives The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma. Conditions: Leiomyosarcoma, Liposarcoma, Osteosarcoma, Sarcoma, Soft Tissue, Metastases Intervention / Treatment: DRUG: ridaforolimus Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months * Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging \[MRI\] scans) * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Minimum life expectancy of 3 months * Adequate renal and hepatic function, as specified in the protocol * Adequate bone marrow function, as specified in the protocol * Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL * Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug * Able to understand and give written informed consent Exclusion Criteria: * Women who are pregnant or lactating * Presence of brain metastases * Prior therapy with rapamycin, rapamycin analogues or tacrolimus * Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus * Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by National Cancer Institute (NCI) toxicity criteria) * Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ) * Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug * Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin) * Significant uncontrolled cardiovascular disease * Active infection requiring systemic therapy * Known human immunodeficiency virus (HIV) infection * Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus * Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug * Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus * Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug

Study Objectives The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer. Conditions: Breast Cancer Intervention / Treatment: BIOLOGICAL: ramucirumab (IMC-1121B), DRUG: docetaxel, OTHER: Placebo Location: Israel, Taiwan, Croatia, United Kingdom, Germany, Brazil, Poland, Belgium, Peru, Czechia, Australia, United States, Serbia, Ireland, New Zealand, Canada, Egypt, Spain, South Africa, Russian Federation, Slovakia, Korea, Republic of, Lebanon Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Participant is able to provide signed informed consent * Participant is female and ≥ 18 years of age or older if required by local laws or regulations * Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis * Participant has measurable and/or non-measurable disease * Participants' primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC) * Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer * Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization * Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization * Participant completed all prior radiotherapy with curative intent ≥ 3 weeks prior to randomization * Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting ≥ 2 weeks prior to randomization * Participant's left ventricular ejection fraction is within normal institutional ranges * Participant has resolution to grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade ≤ 2 * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Participant is amenable to compliance with protocol schedules and testing * Participant has adequate hematological functions \[absolute neutrophil count (ANC) ≥ 1500 cells/microliter (mcL), hemoglobin ≥ 9 grams/deciliter (g/dL), and platelets ≥ 100,000 cells/mcL and ≤ 850,000 cells/mcL\] * Participant has adequate hepatic function \[bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase ≤ 5.0 times the ULN\] * Participant has serum creatinine ≤ 1.5 x ULN. If serum creatinine > 1.5 x ULN the calculated creatinine clearance should be > 40 milliliters/minute (mL/min) * Participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA); if urine protein ≥ 2+, a 24-hour urine collection must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study * Participant must have adequate coagulation function as defined by international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices) * Women of childbearing potential must implement adequate contraception in the opinion of the investigator * Participant has not received prior biologic therapy for metastatic or locally recurrent and inoperable breast cancer Exclusion Criteria: * Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years * Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80 * Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF) * Participant has a history of chronic diarrheal disease within 6 months prior to randomization * Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization * Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization * Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders * Participant has active, high risk bleeding (such as, via gastric ulcers or gastric varices) within 14 days prior to randomization * Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy * Participant has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator * Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease * Participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness * Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen. * Participant is pregnant or lactating

Study Objectives Trial Design: This is a feasibility randomised controlled trial. Aim: The study aims to test the Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC intervention and HEAL ABC resources for feasibility and will inform a future definitive randomised controlled trial (RCT). Objectives: 1. Is it practical to run HEAL ABC study as a definitive randomised controlled trial? 2. Adherence to intervention, motivations, barriers and facilitators of CRC survivors to follow HEAL ABC. Study Population: Colorectal cancer survivors who completed surgery and/or active treatment. Intervention: The intervention group will use HEAL ABC resource with supportive telephone calls every two weeks during the intervention period and once a month during the follow up period. Control: Participants follow standard care recommendations. Timing and duration: 3 months intervention with 6 months follow up period Conditions: Colorectal Cancer, Survivorship, Behavior, Health Intervention / Treatment: BEHAVIORAL: HEAL ABC Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adults, age ≥18 * Minimum 12 weeks post-surgery and/or active treatment * Completed all active anti-cancer treatments, including surgery, radiotherapy or chemotherapy * Body mass index ≥20 kg/m2 and no previous unintentional weight loss ≥5% of body weight in the previous six months. * Identified as living an unhealthy lifestyle based on current recommendations - follow less than four of the WCRF/AICR recommendations on eligibility questionnaire * Ability to work with computer, smart phone or tablet. * Able to give informed consent. Exclusion Criteria: * Receiving treatment for malignancy. * Secondary malignancy. * Having short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis or jejunostomy (due to requirement for a very specific diet). * Previous stroke, congested cardiac failure or oedema. * Hepatic or renal failure * Less than 12 weeks post-surgery or active treatment. * Meeting the requirements of a healthy lifestyle (follow four or more of the WCRF/AICR recommendations). * Being on any therapeutic diets, multiple food intolerances or allergies. * Unplanned weight loss of ≥10% in the previous 3-6 months. * Cannot read or communicate in English (due to resource constraints of this PhD study).

Study Objectives Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain despite of no influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE. Bevacizumab has been administrated locally in treating optic nerve sickness successfully by anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in treating MPE. Conditions: Non-small Cell Lung Cancer, Malignant Pleural Effusion Intervention / Treatment: DRUG: Bevacizumab Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological or cytological diagnosis of non-small cell lung cancer. * Cytological diagnosis of malignant pleural or pericardial effusion (MPE) * Symptomatic MPE evaluated by researchers * Unsuitable for or reject systemic therapy of tumor * Estimated survival of more than 3 months. 6.18 years or older Exclusion Criteria: * Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants * Be allergic to bevacizumab * Pregnant or lactating woman * Pleural or pericardial infection

Study Objectives Busulfan and etoposide have been used as preparative therapy for autoSCT (stem cell transplant) in adults with acute myeloid leukemia (AML) at UCSF for the past 10 years. Over this period and together with collaborative transplant centers, over 200 patients have received this treatment. By intent-to-treat analysis, and with median follow-up of 7.0 years, the 5-year DFS is 55%. The current protocol will utilize the combination of IV Busulfan (BU) and etoposide. The busulfan dose will be escalated amongst 3 targeted dose levels. All targeted dose levels represent higher busulfan dosing than standard myeloablative dosing, with the lowest dose being approximately 14% higher than standard. Busulfan levels will be monitored after the first, fourth and twelfth doses. Dose adjustments will be made "in real time" based on AUC levels determined from the first and fourth doses. This strategy of busulfan monitoring and dose adjustment has improved the therapeutic widow of BU in previous clinical trials. The current protocol will utilize the combination of intravenous busulfan and etoposide. The busulfan dose will be escalated amongst 3 targeted dose levels (area under the curve (AUC) levels at time 6 hours of 1250 uMol\*min, 1400 uMol\*min and 1550 uMol\*min). All targeted dose levels represent higher busulfan dosing than standard myeloablative dosing with the lowest dose (1250 uMol\*min) being approximately 14% higher than standard. In the absence of dose-limiting toxicity, cohorts of 4-6 patients will be treated at each dose level and 10 additional patients will be treated at the maximum tolerated dose (MTD) to confirm safety. The busulfan dosing will begin at 1 mg/kg based on historical plasma levels obtained from patients receiving BU at a starting dose of 0.8 mg/kg at UCSF Medical Center. The highest dose level proposed for this study will exceed the reported toxic level for busulfan in the alloSCT setting. Patients will be followed closely for toxicity and strict stopping rules have been included. Eligibility criteria will exclude patients with prior history of hepatotoxicity or viral hepatitis. Potential hepatotoxic agents will not be allowed just prior to and during the busulfan dosing period. In addition, patients who experience hepatotoxicty during pre-transplant mobilization therapy may be excluded from receiving dose-escalated busulfan therapy. Every attempt will be made to prevent or avoid hepatotoxicity. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: Busulfan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Before Consolidation Chemotherapy * Age 18-69 years * Diagnosis of AML * CR with ≤2 courses of induction chemotherapy. * Out of the hospital for a minimum of 4 weeks from induction chemotherapy or 3 weeks if consolidation chemotherapy has been administered. * Remission bone marrow bx w/i 2 wks of beginning post remission rx. * One cycle of post-remission consolidation w/standard dose cytarabine or HDAC with <8 doses of HDAC. * Benign CSF: Lumbar puncture with cell count, differential and protein to determine lack of extramedullary leukemia required w/i 2 weeks of post- remission therapy IF CSF status is unknown or has been positive at dx. * No active infection * No evidence of prior liver disease. * Creatinine <2.0 mg/dl. * Cardiac ejection fraction ≥40%. * Adequate pulmonary function with DLCO ≥40% of predicted. * No co-morbid medical condition that would jeopardize the chance of tolerating aggressive chemotherapy. * ECOG 0-2 * Signed informed consent. Eligibility to be Re-assessed Before Autologous SCT * Minimum of 4 weeks out of hospital after post-remission rx. * Continued CR documented by bone marrow morphology and cytogenetics (if previously abnormal), performed within 2 wks of admission for autologous transplantation. * Adequate marrow recovery from post-remission therapy as demonstrated by an ANC ≥ 500/µl, platelets ≥ 50,000/µl and stable or improving hemoglobin (transfusion independent). * Adequate peripheral stem cells collected and stored; * No evidence of liver dysfunction as determined within 2 weeks of transplant admission. Bilirubin must be < 2.0 mg/dl and the AST and alkaline phosphatase < 3x the upper limit of normal. * Creatinine < 2.0 mg/dl. * No active infection or need for ongoing antibiotics.

Study Objectives The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries. Conditions: Acute Myeloid Leukemia, Acute Lymphoid Leukemia Location: Chile, Argentina, Colombia, Brazil Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients ≥18 years old at diagnosis * Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019 * At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period Exclusion Criteria: * Patients with no medical chart available * Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data) * Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment * Patients with secondary AML * Patients with any concomitant primary malignancy * Patients with acute promyelocytic leukemia (APL)

Study Objectives Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation, to sites in the body. All participants in this study will be treated with SBRT using proton beam radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors. The purpose of this research study is to determine if SBRT with protons will prevent tumor growth and reduce the treatment side effects for liver metastases. Conditions: Solid Tumor, Liver Metastases Intervention / Treatment: RADIATION: Stereotactic body radiotherapy-proton Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Biopsy-proven cancer diagnosis of a solid tumor with 1-4 liver metastases. There is no upper size limit. Liver metastases may be diagnosed by imaging alone, no liver biopsy is required. Extrahepatic disease is allowed if it have been stable for 3 months prior to study entry, the dominant disease burden is intrahepatic and the patient is referred for definitive radiation therapy to the disease in the liver * 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 had prior chemotherapy, targeted biological therapy, surgery, transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for their disease as long as the prior therapy occured greater than 3 weeks elapsed before the first radiation treatment. Patients may not have had prior liver directed radiation, including radioembolization. * 18 years of age or older * Expected survival must be greater than three months * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Patients must have at least 800mL of uninvolved liver * Normal organ and marrow function as outlined in the protocol * If patient has underlying cirrhosis, only Child-Pugh classification Group A patients should be included in this study. Clinical assessment of ascites and encephalopathy is required. Child-Pugh classification must be determined for all study participants at the time of eligibility analysis. * 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: * Women who are pregnant or lactating * Patients with gross ascites or encephalopathy * Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc. * Prior liver directed radiation treatment, including selective internal radiation * No serious medical illness, which may limit survival to less than 3 months * No serious psychiatric illness which would limit compliance with treatment * Participants who have had chemotherapy or radiotherapy within 3 weeks prior to starting study treatment or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier * Participants may not be receiving any other investigational agents, or any other anti-cancer therapy during treatment * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia. * Only solid tumors are permitted. Thus, individuals with a liver mass from a diagnosis of lymphoma or leukemia are excluded

Study Objectives This is an open-label, dose-escalation study of ARQ 197 administered orally in combination with sorafenib. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: Treatment with ARQ 197 in combination with sorafenib Location: Italy, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Written informed consent granted prior to initiation of any study-specific screening procedures * 18 year of age or older * Histologically or cytologically confirmed locally advanced, inoperable or metastatic solid tumors. In the two expansion cohorts, only patients with histologically or cytologically confirmed HCC, RCC, breast cancer, NSCLC and melanoma are eligible. An exception for this criterion is that patients with HCC may be enrolled without histological confirmation of disease so long as they meet the following criteria for diagnosis of HCC (and all other protocol eligibility criteria): 1. Lesion > 2cm in diameter 2. α-fetoprotein (AFP) > 200 ng/mL 3. Radiological appearance of mass is suggestive of HCC * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1 * Adequate bone marrow, liver, and renal functions, defined as: * Platelet count ≥ 100 × 10\^9/L (≥ 60 × 10\^9/L for HCC patients enrolled in the expanded cohort) * Hemoglobin ≥ 10 g/dL * Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L * Total bilirubin ≤ 1.5 mg/dL or ≤ 3 mg/dL with HCC or metastatic liver disease * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with HCC or metastatic liver disease * Serum creatinine ≤1.5 × ULN * International normalized ratio (INR) 0.8 to 1.2 or 2 to 3 for patients receiving anticoagulant such as coumadin or heparin. Patients who are therapeutically anticoagulated are allowed to participate provided that no prior evidence of underlying abnormality exists in these parameters * Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug * Male and female subjects of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received Exclusion Criteria: * Previous anti-cancer chemotherapy, radiotherapy, immunotherapy or investigational agents within 4 weeks prior to the first day of study defined treatment with the following exceptions: 1) a prostate cancer patient on androgen deprivation with gonadotropin-releasing hormone (GnRH) agonists can be enrolled while he remains on the immunotherapy; 2) a patient received palliative radiotherapy previous can be enrolled if the therapy was completed 1 week (7 days) prior to the first day of study defined treatment and the patient has recovered from any radiotherapy-related adverse event(s); and 3) patients are currently on sorafenib can be enrolled * History of cardiac disease: congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); previously diagnosed clinically significant bradycardia, other uncontrolled cardiac arrhythmia defined as ≥ Grade 2 according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (version 3.0), or uncontrolled hypertension; myocardial infarction occurred within 6 months prior to study entry (myocardial infarction occurred > 6 months prior to study entry is permitted) * Active clinically serious infections defined as ≥ Grade 2 according to NCI CTCAE, version 3.0 * Substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results * Any condition that is unstable or which could jeopardize the safety of the patient and his/her protocol compliance * Known human immunodeficiency virus (HIV) infection * Pregnancy or breast-feeding * Inability to swallow oral medications * Significant gastrointestinal disorder, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or sorafenib (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection).

Study Objectives Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around 10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone call (given by a doctor) to improve colonoscopy participation. And try to understand why this patients don't want to make this examination. Conditions: Colon Cancer Intervention / Treatment: BEHAVIORAL: Colofit+ intervention Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * immunochemical fecal test positive but no colonoscopy performed despite a full sequence of reminder (3 letters) Exclusion Criteria: * colonoscopy done

Study Objectives This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG. Conditions: Bladder Cancer Intervention / Treatment: DRUG: Sirolimus Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer * In their treating physician's opinion is a good candidate for BCG therapy * Be able to give informed consent * Be age 18 or older * Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids) * Not have active, uncontrolled infections * Not be on agents known to alter rapamycin metabolism significantly * Not have a reported history of liver disease (e.g. cirrhosis) * Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin. * Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy. Exclusion Criteria: * Have muscle-invasive (≥T2) bladder cancer * Unable to give informed consent * Age < 18 * Immunosuppressed state (e.g. HIV, use of chronic steroids) * Active, uncontrolled infections * On agents known to alter rapamycin metabolism significantly * Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin) * Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy. * Individuals with a reported history of liver disease (e.g. cirrhosis) * Individuals who are not a good candidate for BCG in their treating physician's opinion