Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of STI571 for cohorts of patients with varying degrees of renal dysfunction (normal, mild, moderate, and severe). II. To determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of STI571. III. To evaluate the safety of STI571 in patients with various degrees of renal dysfunction. OUTLINE: This is a dose-escalation study. Patients are stratified according to creatinine clearance (at least 60 mL/min vs 40-59 mL/min vs 20-39 mL/min vs less than 20 mL/min vs any creatinine clearance and undergoing dialysis). Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each stratum receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 60-69 patients (about 12 per stratum) will be accrued for this study.