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RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of safingol when given with cisplatin in treating patients with locally advanced or metastatic solid tumors.
- Determine the maximum tolerated dose (MTD) of safingol when administered with cisplatin in patients with locally advanced or metastatic solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
- Determine a safe dose (i.e., near the MTD) for phase II evaluation of this regimen in these patients.
- Determine, preliminarily, the role of ceramide and S1P, relative to response and apoptosis, in patients treated with this regimen.
OUTLINE: This is an open-label, non-randomized, dose-escalation study of safingol.
Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only; course 1 is 28 days in duration.
Cohorts of 3-6 patients receive escalating doses of safingol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level.
PROJECTED ACCRUAL: A total of 3-52 patients will be accrued for this study within 1-18 months.
Masking: Open Label, Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:18-0400
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