Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Efficacy (complete and partial response) [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||July 2004|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
- 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.
|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|