Spots Global Cancer Trial Database for Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
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Trial Identification
Brief Title: Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
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 ID: NCT00005966
Conditions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center-Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Comprehensive Cancer Center at Our Lady of Mercy Medical Center, Bronx, New York, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
Westmead Hospital, Westmead, New South Wales, Australia
Instituto de Enfermedades Neoplasicas, Lima, , Peru
San Juan City Hospital, San Juan, , Puerto Rico
Contact Details
Name: Michael S. Gordon, MD
Affiliation: Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Role: STUDY_CHAIR
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