PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Kenneth B. Von Eschen, PhD
Study Chair
GlaxoSmithKline
United States: Federal Government
CDR0000064732
NCT00002767
January 1996
Name | Location |
---|---|
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Christ Hospital | Cincinnati, Ohio 45219 |
CCOP - Columbus | Columbus, Ohio 43206 |
Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
University of New Mexico Cancer Research & Treatment Center | Albuquerque, New Mexico 87131 |
Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |
Creighton University Cancer Center | Omaha, Nebraska 68131-2197 |
Southwest Regional Cancer Center | Austin, Texas 78705 |
Hematology Oncology Consultants Inc | Columbus, Ohio 43235 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
University of California San Diego Cancer Center - La Jolla | La Jolla, California 92093-0686 |
Kaiser Permanente Medical Center-Sacramento | Sacramento, California 95825 |
Kaiser Permanente Medical Group - San Francisco | San Francisco, California 94115 |
Adventist Health System/Sunbelt, Inc. | Orlando, Florida 32803 |
Emory University School of Medicine | Atlanta, Georgia 30322 |
University of Louisville Hospital | Louisville, Kentucky 40202 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |