lenalidomide in treating patients with advanced or unresectable kidney cancer

Conditions: Kidney Cancer

Summary: 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.

objectives: * 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.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed renal cell carcinoma (rcc) * advanced or unresectable rcc * measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral ct scan * no brain metastases * brain metastases that have been treated with either radiotherapy or surgery and remain asymptomatic, with no active brain metastases, as shown by ct scan or mri, for ≥ 6 months are allowed patient characteristics: * ecog performance status (ps) 0-1 or karnofsky ps 70-100% * absolute neutrophil count ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * creatinine ≤ 2.0 mg/dl * bilirubin ≤ 1.5 mg/dl * ast and alt ≤ 2.5 times upper limit of normal (uln) (5 times uln if hepatic metastases are present) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancies within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer * no history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide or thalidomide * no uncontrolled intercurrent illness including, but not limited to, any of the following: * ongoing or active infection * symptomatic congestive heart failure * unstable angina pectoris * cardiac arrhythmia * psychiatric illness or social situation that would limit study compliance * no hepatitis a, b, or c positivity * no hiv positivity prior concurrent therapy: * see disease characteristics * no more than 1 prior systemic therapy for rcc (e.g., chemotherapy, hormonal therapy, immunotherapy) * at least 4 weeks since prior surgery, radiotherapy, hormonal therapy, chemotherapy, or immunotherapy and recovered * no prior lenalidomide * no other concurrent anticancer agents or treatments * no other concurrent investigational agents * no concurrent sargramostim (gm-csf), radiotherapy, or thalidomide

Keywords: stage iii renal cell cancer stage iv renal cell cancer recurrent renal cell cancer