Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
|ClinicalTrials.gov Identifier: NCT00096525|
Recruitment Status : Completed
First Posted : November 10, 2004
Last Update Posted : January 17, 2013
RATIONALE: Biological therapy such as lenalidomide use different ways to stimulate the immune system and stop tumor cells from growing. It may also stop the growth of tumor cells by stopping 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|
- Determine the best response in patients with advanced or unresectable renal cell cancer treated with lenalidomide (CC-5013).
- Determine the time to disease progression in patients treated with this drug.
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen|
|Study Start Date :||July 2004|
|Primary Completion Date :||August 2005|
- Efficacy (complete and partial response)
- Adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096525
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Gnanamba V. Kondagunta, MD||Memorial Sloan Kettering Cancer Center|