Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have metastatic kidney cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Arsenic Trioxide (NSC #706363) in Patients With Advanced Renal Cell Carcinoma|
|Study Start Date:||January 2000|
|Study Completion Date:||July 2001|
|Primary Completion Date:||July 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the efficacy of arsenic trioxide in patients with metastatic renal cell cancer. II. Determine the safety of this regimen in this patient population.
OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours daily for 5 days. Treatment continues every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Robert J. Motzer, MD||Memorial Sloan-Kettering Cancer Center|