This trial is active, not recruiting.

Condition kidney cancer
Treatment lenalidomide
Phase phase 2
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Overall response
time frame:

Secondary Outcomes

time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.