Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00075660
Brief 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.
Study:
NCT00075660
Study Brief:
Protocol Section:
NCT00075660