Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with or without thalidomide in treating patients who have previously untreated metastatic or unresectable kidney cancer.
Biological: recombinant interferon alfa
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma|
|Study Start Date:||October 2000|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- Compare the overall and progression-free survival at 24 weeks in patients with previously untreated metastatic or unresectable renal cell carcinoma treated with interferon alfa-2b with or without thalidomide.
- Compare the safety of these 2 regimens in these patients.
- Compare the quality of life of patients treated with these 2 regimens.
- Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements of angiogenesis such as serum and plasma angiogenic factor levels in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no), disease-free interval (no more than 1 year vs more than 1 year), and ECOG performance status (0 vs 1 or 2). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive interferon alfa-2b subcutaneously (SC) twice daily beginning on day 1.
- Arm II: Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily beginning on day 1.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) continue treatment for 24 weeks past CR.
Quality of life is assessed prior to randomization and then every 4 weeks through week 24.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 346 patients (173 per arm) will be accrued for this study within 2 years.
|United States, Arizona|
|CCOP - Mayo Clinic Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, Indiana|
|CCOP - Northern Indiana CR Consortium|
|South Bend, Indiana, United States, 46601|
|United States, Iowa|
|Iowa Lutheran Hospital|
|Des Moines, Iowa, United States, 50316-2301|
|John Stoddard Cancer Center at Iowa Methodist Medical Center|
|Des Moines, Iowa, United States, 50309|
|Mercy Cancer Center at Mercy Medical Center-Des Moines|
|Des Moines, Iowa, United States, 50314|
|United States, Nebraska|
|Midlands Cancer Center at Midlands Community Hospital|
|Papillion, Nebraska, United States, 68128-4157|
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New Mexico|
|MBCCOP - University of New Mexico HSC|
|Albuquerque, New Mexico, United States, 87131|
|United States, New York|
|Comprehensive Cancer Center at Our Lady of Mercy Medical Center|
|Bronx, New York, United States, 10466|
|United States, Pennsylvania|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|United States, Wisconsin|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay|
|Green Bay, Wisconsin, United States, 54307-3453|
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Instituto de Enfermedades Neoplasicas|
|Lima, Peru, 34|
|San Juan City Hospital|
|San Juan, Puerto Rico, 00936-7344|
|Study Chair:||Michael S. Gordon, MD||Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea|