Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I Study of Triapine in Combination With High Dose Ara-C (Hi-DAC) in Patients With Advanced Hematologic Malignancies
Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by making them more sensitive to the drug. This phase I trial is studying the side effects and best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced hematologic malignancies
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of 3-AP (Triapine) administered with high-dose
cytarabine in patients with advanced hematologic malignancies.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this regimen in these patients. II. Determine the
effect of treatment with 3-AP (Triapine) on intracellular levels of cytarabine in these
patients.
OUTLINE: This is a dose-escalation study of 3-AP (Triapine).
Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and 3-AP (Triapine) IV
over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence
of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients in each stratum receive escalating doses of 3-AP (Triapine) 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.
Patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 6-48 patients (3-24 per stratum) will be accrued for this
study within 15-24 months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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