A Phase I Study of Triapine in Combination With High Dose Ara-C (Hi-DAC) in Patients With Advanced Hematologic Malignancies
I. Determine the maximum tolerated dose of 3-AP (Triapine) administered with high-dose
cytarabine in patients with advanced hematologic malignancies.
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
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
MTD defined as the dose preceding that at which greater than or equal to 2 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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