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.
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.
Minimum age: 18 Years.
Maximum age: N/A.
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama 35294, United States
Beckman Research Institute, City of Hope, Duarte, California 91010, United States
Kaiser Permanente Medical Center - Oakland, Oakland, California 94611, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California 95051-5386, United States
Kaiser Permanente Medical Center - Vallejo, Vallejo, California 94589, United States
Kaiser Permanente Medical Center-Sacramento, Sacramento, California 95825, United States
Kaiser Permanente Medical Group - San Francisco, San Francisco, California 94115, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California 94115-0128, United States
University of California San Diego Cancer Center - La Jolla, La Jolla, California 92093-0686, United States
University of Connecticut Health Center, Farmington, Connecticut 06360-7106, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut 06520-8028, United States
Adventist Health System/Sunbelt, Inc., Orlando, Florida 32803, United States
Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States
Emory University School of Medicine, Atlanta, Georgia 30322, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois 60068, United States
University of Louisville Hospital, Louisville, Kentucky 40202, United States
Creighton University Cancer Center, Omaha, Nebraska 68131-2197, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire 03756, United States
University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico 87131, United States
Interlakes Oncology/Hematology PC, Rochester, New York 14623, United States
Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio 45219, United States
CCOP - Columbus, Columbus, Ohio 43206, United States
Christ Hospital, Cincinnati, Ohio 45219, United States
Hematology Oncology Consultants Inc, Columbus, Ohio 43235, United States
Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon 97201-3098, United States
Southwest Regional Cancer Center, Austin, Texas 78705, United States