Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
|ClinicalTrials.gov Identifier: NCT00403169|
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : April 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: lenalidomide||Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Experimental: Lenalidomide for Advanced RCC
25 mg/day Lenalidomide for 21 days per cycle.
Other Name: CC-5013
- Overall response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403169
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Robert Dreicer, MD, FACP||Case Comprehensive Cancer Center|