Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)

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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lenalidomide for Advanced RCC<br>25 mg/day Lenalidomide for 21 days per cycle. | Drug: lenalidomide<br>* drug<br>* Other names: CC-5013;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response |  |  | 

Secondary Outcome Measures

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

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