Kidney Cancer Clinical Trial
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Summary
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.
Full Description
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.
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
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There is 1 Location for this study
New York New York, 10021, United States
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