Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
This trial is active, not recruiting.
|Sponsor||The Cleveland Clinic|
|Collaborator||National Cancer Institute (NCI)|
|Start date||August 2004|
|Trial size||26 participants|
|Trial identifier||NCT00403169, CASE-CCF-7165, P30CA043703|
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.
Male or female participants at least 18 years old.
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
|Official title||Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)|
|Description||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.|
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