Kidney Cancer Clinical Trial
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
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Masking: Open Label, Primary Purpose: Treatment
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