Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer Read More

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