Status:
COMPLETED
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 advanc...
Detailed 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, a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00403169
Start Date
August 1 2004
End Date
May 1 2009
Last Update
April 20 2017
Active Locations (1)
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1
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065