A Phase I Study of Triapine and Cytarabine in Patients With Hematologic Malignancies
- 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
- Determine the biological effects of 3-AP and its interaction with cytarabine in these
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
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.
Primary Purpose: Treatment
Mario Sznol, MD
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|