Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT00075660
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Study Overview
Official Title:
A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: