Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma (RCC) Advanced or unresectable disease At least 1 measurable lesion No active brain metastases Prior brain metastases allowed provided patient has been treated with radiotherapy or surgery AND remains asymptomatic for ≥ 6 months PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) No hepatitis A, B, or C infection Renal Creatinine ≤ 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No known hypersensitivity to thalidomide No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer PRIOR CONCURRENT THERAPY: Biologic therapy No more than 1 prior systemic immunotherapy regimen for RCC No prior lenalidomide (CC-5013) No prior or concurrent thalidomide Chemotherapy No more than 1 prior systemic chemotherapy regimen for RCC Endocrine therapy No more than 1 prior systemic hormonal therapy regimen for RCC Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery See Disease Characteristics At least 4 weeks since prior surgery and recovered Other No more than 1 other prior systemic therapy regimen for RCC No other concurrent anticancer therapies No other concurrent investigational agents
Sites / Locations
- Memorial Sloan-Kettering Cancer Center