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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada