NCT00075660

3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma

A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have locally recurrent or metastatic renal cell (kidney) carcinoma (cancer).

Detailed description

OBJECTIVES: Primary * Determine the efficacy of 3-AP (Triapine®), in terms of objective response rate, in patients with previously untreated locally recurrent or metastatic renal cell carcinoma. Secondary * Determine the adverse events and tolerability of this drug in these patients. * Determine the time to disease progression and overall survival of patients treated with this drug. OUTLINE: This is a nonrandomized, multicenter study. Patients receive 3-AP (Triapine®) IV over 2 hours on days 1-4 and 15-18. Treatment repeats every 28 days for up to 6 courses (for stable patients) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional course after documentation of CR. Patients who achieve a partial response (PR) receive 2 additional courses after documentation of stable PR. Patients are followed every 4 weeks until relapse and then every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	triapine

Timeline

• Start date: 2004-05-11
• Primary completion: 2005-10-04
• Completion: 2008-09-22
• First posted: 2004-01-12
• Last updated: 2023-08-04

Locations

8 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study