Lenalidomide 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.

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