View clinical trials related to Solid Tumor.
Filter by:This will be a dose escalation study to determine the maximum tolerated dose (MTD) and the overall safety and tolerability of a topical compound 31543 (Calcitriol) in patients with metastatic or recurrent cancer who are undergoing chemotherapy with a taxane-based regimen.
Primary Objective: - To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). - To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Secondary Objectives: - To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1 - To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2 - To determine antitumor activity in Segment 2
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
In preclinical studies, the anti-cancer efficacy of fenretinide, a synthetic retinoid that causes cytotoxicity by mechanisms which include increased intracellular dihydroceramides, has been shown to be enhanced by safingol, a stereochemical-variant dihydroceramide precursor. This phase I study represents the first clinical trial employing this promising combination. The drug administration schedule (fenretinide given on Days 1-5, safingol given on Days 1-2 of each 21-day cycle) reflects the in vitro observation that tumor cell exposure to safingol increased fenretinide efficacy both during and after safingol administration. The total dose of fenretinide, 4600 mg/m2 over 5 days, represents a 30% total dose reduction from the single agent MTD dose of 1280 mg/m2/day x 5 days determined on the PhI-42 study. This fenretinide dose is expected to produce plasma levels in the 30?s ?M. This dose reduction has been employed to reduce the potential for overlapping hepatic toxicities between these two agents. The administration of a reduced fenretinide dose on Day 1 (600 mg/m2 on Day 1, escalated to 1000 mg/m2/day on Days 2-5) has been selected due to earlier observations that initial exposure to the soy bean oil vehicle in the fenretinide emulsion may induce endogenous lipases, thereby permitting tolerance of higher total doses fenretinide emulsion subsequently administered. The starting dose of safingol in this study, 210 mg/m2/day x 2 days (420 mg/m2 total), corresponds to 50% of the recommended Phase II safingol dose (bolus) determined in the Schwartz, et al, Phase I study of safingol plus cisplatin 60 mg/m2 (the MTD of single-agent, intravenous (emulsion) safingol was not reached in the Phase I safingol run-in monotherapy portion of this study), and was selected to provide an adequate safety margin against the potential for overlapping toxicities (such as hepatic transaminitis). The study has been designed to optimize the safety of this novel combination. Treatment will be administered in the inpatient setting. Central venous access will be mandated to avoid the potential for hemolysis and thrombophlebitis associated with the preclinical peripheral administration of a previous safingol formulation in rats. To reduce the incidence of hypertriglyceridemia, a revised fenretinide delivery schedule will be employed. Patients will also be encouraged to maintain a low-fat diet during fenretinide administration. Serum triglycerides will be monitored every 12 hours. To monitor for cardiac toxicity, which was noted in canine studies at the highest dose of safingol plus fenretinide tested, serum troponin T levels will be monitored daily. To limit the potential for hepatotoxicity resulting from a possible drug interaction observed between intravenous fenretinide, ceftriaxone and acetaminophen in a pediatric patient, the concurrent administration of ceftriaxone, or acetaminophen, with the fenretinide emulsion infusion will be prohibited.
Autologous stem cell rescue is an established therapy in high risk neuroblastoma and relapsed Hodgkin's lymphoma and an experimental therapy in some other solid and brain tumors to facilitate the use of very intense chemotherapy beyond bone marrow tolerance. It is usually tolerated with acceptable toxicity and graft failure is practically not existent. But whereas immune reconstitution in allogeneic hematopoietic stem cell transplantation (HSCT) setting is widely studied, the investigators have no comprehensive data available in the autologous setting regarding recovery of the innate and adaptive immune system. However, observations in patients with autoimmune disease undergoing autologous HSCT suggest not an exact recovery of the patient's pre-transplant immune system but some re-education during reconstitution of immune function. Also, recent developments of cancer-directed immunotherapy with monoclonal antibodies and immunocytokines rely on activity of the patient's own immune system via complement-mediated or antibody-dependent cellular cytotoxicity. These novel therapies are given either with or shortly after conventional chemotherapy. To find the optimal time point for administration of immunotherapy, it is important to know how and when immune effector cells recover after conventional myelosuppressive and/or immunosuppressive chemotherapy which are used in Induction regimens. Researchers at St. Jude Children's Research Hospital want to study the research participant's immune profile once prior and at multiple set time points after autologous stem cell infusion during the recovery process. In a subset of participants the investigators want to study the recovery of lymphocyte subsets and function after one course of conventional chemotherapy preceding the high dose chemotherapy and autologous stem cell transplant. That way the investigators hope to learn about the pace and order of recovery and the functional capacity of different compartments of the immune system during reconstitution.
This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092.
Background: - Pazopanib is an anticancer drug that blocks the growth of new blood vessels in tumors. It has been approved to treat renal cell cancer and soft tissue sarcomas in patients who have received prior chemotherapy. ARQ 197 (Tivantinib) is an experimental drug that blocks a protein called mesenchymal-epithelial transition factor (c-MET), which cancer cells need to grow. Studies suggest that some drugs that block blood vessel growth can increase the production of c-MET in tumors, which helps cancer cells keep growing. Blocking both blood vessel growth and c-MET with pazopanib and ARQ 197 may help kill cancer cells faster. This study will use these drugs to treat solid tumors that have not responded to earlier treatments. Objectives: - To test the safety and effectiveness of pazopanib and ARQ 197 for advanced solid tumors. Eligibility: - Individuals at least 18 years of age who have advanced solid tumors that have not responded to earlier treatments. Design: - Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and imaging studies. - The study drugs will be given in 4-week cycles of treatment. Participants will take pazopanib once a day and ARQ 197 twice a day by mouth. Some participants will start with pazopanib or ARQ 197 alone for the first week. Then they will take both drugs together for the rest of the study. - Participants will be monitored with frequent blood tests and imaging studies. Optional tumor samples may be collected during different treatment cycles.
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
The purpose of this study is to assess the pharmacokinetics (PK) of enzastaurin and its metabolites in native Chinese participants with advanced and/or metastatic solid tumors or lymphoma. Information about any side effects that may occur will also be collected. Treatment of disease is not the main purpose of the study. This is a Phase 1 study of enzastaurin in native Chinese participants with advanced and/or metastatic solid tumors or lymphoma. Participants will receive daily doses of enzastaurin for 14 days, stop dosing for 3 days during PK sampling, and resume dosing on Day 18. Participants may be allowed to receive enzastaurin for approximately 2 to 4 weeks after day 18 to provide an opportunity for a participant's oncologist to assess the potential benefit of the participant continuing to receive enzastaurin in the safety extension phase. There is no planned duration for the extension phase; participants are allowed to continue receiving enzastaurin until disease progression or other reason for discontinuation as per the investigator's assessment.
The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to patients with advanced solid tumor and gastric cancer.