Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)|
- Overall response
|Study Start Date:||August 2004|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide for Advanced RCC
25 mg/day Lenalidomide for 21 days per cycle.
Other Name: CC-5013
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403169
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Robert Dreicer, MD, FACP||Case Comprehensive Cancer Center|