A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Cancer Patients Using a 96-Hour Intravenous Continuous Infusion
OBJECTIVES: I. Determine the safety, tolerability, and toxicity of 3-AP in patients with
advanced malignancies. II. Determine the maximum tolerated dose and recommended phase II
dose of this treatment in these patients. III. Determine the pharmacokinetic parameters of
this treatment in these patients. IV. Determine the tumor response in these patients treated
with this regimen.
OUTLINE: This is a dose escalation, multicenter study. Patients receive 3-AP IV continuously
over 96 hours. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity. Patients with complete response receive treatment for 1 course past
the course in which the complete response was documented; patients with partial response may
receive treatment for up to 1 year; and patients with stable disease may receive treatment
for up to 6 months. During the accelerated phase of the study, cohorts of 1 patient each
receive escalating doses of 3-AP until one patient experiences dose limiting toxicity (DLT)
or 2 different patients experience grade 2 toxicity during any course. When the accelerated
phase ends, cohorts of 3-6 patients receive escalating doses of 3-AP until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience DLT.
PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study.
Primary Purpose: Treatment
Mario Sznol, MD
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|