RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of talotrexin in treating patients with advanced or recurrent solid tumors.
OBJECTIVES: Primary * Determine the maximum tolerated dose of talotrexin in patients in patients with advanced or recurrent solid tumors. * Determine the safety of this drug in these patients. * Determine the dose-limiting toxic effects of this drug in these patients. Secondary * Determine the pharmacokinetics of this drug in these patients. * Correlate pharmacokinetic parameters of this drug or patient characteristics with drug-related toxicity in these patients. * Determine, preliminarily, the antitumor efficacy of this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive talotrexin IV over 5 minutes on day 1 OR days 1 and 8 OR days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of talotrexin 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. An additional 6-10 patients are treated at the MTD. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
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