Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen
18 Years
N/A
Both
Kidney Cancer
Trial Information
Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen
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 patients treated with this drug.
Secondary
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy (complete and partial response)
Safety Issue:
No
Principal Investigator
Gnanamba V. Kondagunta, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
04-014
NCT ID:
NCT00096525
Start Date:
July 2004
Completion Date:
Related Keywords:
- Kidney Cancer
- recurrent renal cell cancer
- stage III renal cell cancer
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
