Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00002767
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vaccine plus interferon alfa is more effective than interferon alfa alone in treating patients with metastatic melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma.
- Detailed Description
OBJECTIVES: I. Compare survival following immunotherapy with an allogeneic melanoma vaccine plus interferon alfa-2b (IFN-A) vs. IFN-A alone in patients with metastatic melanoma. II. Assess the safety and toxicity of immunotherapy with an allogeneic melanoma vaccine plus IFN-A in these patients. III. Compare the frequencies of durable complete responses in each treatment group. IV. Compare overall clinical objective response, duration of response, and time to disease progression in each treatment group. V. Compare the effects of immunotherapy with an allogeneic melanoma vaccine plus IFN-A vs IFN-A alone on quality of life in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by location of metastatic sites (visceral and bone vs nonvisceral and lung) and number of metastatic sites (1 vs 2 vs 3 or more). Patients are randomized to one of two treatment arms. Arm I: Patients receive allogenic melanoma cell lysate vaccine with detoxified endotoxin subcutaneously (SQ) weekly on weeks 1-5 and 8-12. Interferon alfa (IFN-A) SQ is administered three times a week beginning on week 4. Patients with responding or stable disease receive vaccine monthly beginning on week 16. IFN-A continues in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive IFN-A SQ three times a week beginning on week 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before, during, and after treatment. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 300 patients will be entered over 2 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Creighton University Cancer Center
🇺🇸Omaha, Nebraska, United States
Hematology Oncology Consultants Inc
🇺🇸Columbus, Ohio, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Adventist Health System/Sunbelt, Inc.
🇺🇸Orlando, Florida, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Kaiser Permanente Medical Center-Sacramento
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Group - San Francisco
🇺🇸San Francisco, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
University of New Mexico Cancer Research & Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of California San Diego Cancer Center - La Jolla
🇺🇸La Jolla, California, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Oregon Cancer Center at Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States