An Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP) in Cancer Patients Using a Single Daily Dose for Five Days
OBJECTIVES: I. Determine the effects of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone
(3-AP) in patients with solid tumors by evaluating the safety and tolerability, maximum
tolerated dose (MTD) and recommended dose for Phase II studies, pharmacokinetics, and tumor
OUTLINE: This is a dose escalation study. Patients receive 3-aminopyridine-2-carboxaldehyde
thiosemicarbazone (3-AP) IV over 2 hours on days 1-5. Treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity. Cohorts of 1-6 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 dose limiting
toxicity. Patients are followed for 4 weeks or until recovered.
PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study.
Primary Purpose: Treatment
Mario Sznol, MD
United States: Federal Government
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|
|Arizona Clinical Research Center||Tucson, Arizona 85712|