RATIONALE: Drugs used in chemotherapy such as polyglutamate camptothecin may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. PURPOSE: Phase I trial to study the effectiveness of polyglutamate camptothecin in treating patients who have advanced cancer.
OBJECTIVES: * Determine the maximum tolerated dose of polyglutamate camptothecin (CT-2106) in patients with advanced malignancies. * Determine the tolerability of this drug in these patients. * Determine the safety of this drug in these patients. * Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. * Determine the disease response in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive polyglutamate camptothecin (CT-2106) IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond confirmation of complete response. Cohorts of 3-6 patients receive escalating doses of CT-2106 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 12-48 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
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