RATIONALE: Lenalidomide may stop the growth of kidney cancer by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with advanced or unresectable kidney cancer.
OBJECTIVES: * Evaluate the best response in patients with advanced or unresectable renal cell carcinoma (RCC) treated with lenalidomide. * Evaluate the response duration, time to tumor progression, and survival of patients with advanced RCC treated with lenalidomide. * Evaluate the safety of this drug in these patients. OUTLINE: This is an open-label study. Patients receive oral lenalidomide daily on days 1-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
drug
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Objective Response Rate
The objective response rate was defined by RECIST.
Time frame: Baseline and every 2 weeks until study completion, up to 1.5 years
Toxicity--Most Common AEs
Most commonly reported Serious Adverse Events
Time frame: Baseline and every 2 weeks until study completion. Number of cycles is open ended.
Overall Survival
Time frame: 1 to 16 cycles, until patient expires, is lost to follow up or withdraws consent
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