Finding studies
Finding studies
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Lead
Vion Pharmaceuticals
OBJECTIVES: * Determine the feasibility, tolerability, and toxic effects of 3-AP in combination with cytarabine in patients with hematologic malignancies. * Determine the maximum tolerated dose and phase II dose of cytarabine in this regimen in these patients. * Determine the biological effects of 3-AP and its interaction with cytarabine in these patients. OUTLINE: This is a pilot, dose-escalation study of cytarabine. Patients receive 3-AP IV over 6 hours followed by cytarabine IV over 18 hours on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response may receive an additional course as consolidation therapy. Cohorts of 3-6 patients receive escalating doses of cytarabine 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. Once the MTD is determined, an additional 10 patients receive treatment at that dose. PROJECTED ACCRUAL: Approximately 20-25 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
