OBJECTIVES:~I. Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma.~II. Determine the objective response rate in patients treated with this drug.~OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more).~Patients receive oral carboxyamidotriazole (CAI) daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity.~Patients with stable disease are randomized to one of two treatment arms.~Arm I: Patients receive oral CAI as above.~Arm II: Patients receive a placebo.~Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above.~Patients are followed every 6 months.~PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.
Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor