Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: lenalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lenalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (complete and partial response) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer