A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin
OBJECTIVES:
- Determine the maximum tolerated dose of cisplatin when administered with 3-AP in
patients with advanced cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the antitumor responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of cisplatin.
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and
3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of cisplatin 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.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Mario Sznol, MD
Study Chair
Vion Pharmaceuticals
United States: Federal Government
CDR0000068918
NCT00024323
March 2001
Name | Location |
---|---|
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |