NCT00006218

3-AP in Treating Patients With Advanced Cancer

A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Cancer Patients Using a 96-Hour Intravenous Continuous Infusion

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Vion Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of 3-AP in treating patients who have advanced cancer.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	triapine

Timeline

• Start date: 2000-05-01
• Completion: 2008-01-01
• First posted: 2004-03-17
• Last updated: 2013-07-18

Locations

1 site across 1 country: United States