Status:
COMPLETED
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 flo...
Detailed Description
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 pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00096525
Start Date
July 1 2004
Last Update
January 17 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021