Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|