View clinical trials related to Neoplasms.
Filter by:For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.
Background: - Batracylin advanced through the National Cancer Institute (NCI) drug development pipeline until its evaluation at Stage 3 on July 1989, It was then proposed for a phase I investigation based on its activity against as TOPO II inhibitor in s.c. mouse colon 38, PANC03, COLO9, and cisplatin- and doxorubicin-resistant P388 tumors. - IND-directed oral toxicology studies indicated interspecies variation in toxicity. Rats were found to be highly sensitive to batracylin. Ames et al showed that the interspecies variation in toxicity was consistent with the pattern of metabolism of the compound by N-acetyltransferase 2 (NAT2) to the acetylated form, N-Ac-batracylin, (a highly toxic molecule) - We hypothesize that batracylin can be administered safely in slow acetylator NAT2 genotype patients and can be rapidly evaluated for its potential as a tumor-suppressing agent. Objectives: - Define the maximum tolerated dose, dose-limiting toxicities, and toxicity profile associated with the oral administration of batracylin daily x7 consecutive days, repeated every 28 days in patients with solid tumors and lymphomas. - Define the pharmacokinetics of oral batracylin administered daily x7 consecutive days every 28 days. - Obtain preliminary evidence of anti-tumor activity of batracylin in patients with solid tumors or lymphoma. - Correlate polymorphisms in slow acetylators NAT2 genotypes (NAT2 5, NAT2 6, NAT2 7, and NAT2 14) with pharmacokinetics results. - Evaluate the inter-subject variability and toxicity ratio, (N-Ac-Batra) / (batracylin). - Evaluate the effect of batracylin treatment on gamma-H2AX levels in tumor biopsies. Eligibility: - Patients must have a slow acetylator NAT2 genotype defined as NAT2 5, NAT2 6, NAT2 7, or NAT2 14. - Patients with advanced, histologically confirmed malignancies refractory to standard therapy, or those for whom no standard therapy exists. - Patients should have adequate liver, renal, and bone marrow function. Study Design: - In accordance with the accelerated titration design 4B[3], dose levels will initially be increased at 100% increments, and one new patient per dose level will be treated according to a 4-week course. - The accelerated phase ends when one patient experiences dose limiting toxicity (DLT) during the first course of treatment, or when two different patients experience grade 2, batracylin-related toxicity during the first course of treatment, or when the N-acetyl-batra AUC value reach 0.33 uM-Hour (i.e., the lower end of the range in the rat). - When the first instance of grade 2 batracylin-related toxicity is observed, two additional patients must have been treated at that dose, or a higher dose (during any course), without experiencing moderate (grade 2) or worse (grade 3) toxicity, in order for the accelerated phase to continue. - When the accelerated phase ends, the dose-escalation will revert to a more conservative, modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients treated per dose level.
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.
The purpose of this study is to evaluate the progression free survival of capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin) in previously untreated metastatic esophagogastric adenocarcinomas.
The purpose of this study is to assess the safety and tolerability of escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.