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Spots Global Cancer Trial Database for Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma

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Trial Identification

Brief Title: Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma

Official Title: PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA

Study ID: NCT00002767

Conditions

Melanoma (Skin)

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States

Beckman Research Institute, City of Hope, Duarte, California, United States

University of California San Diego Cancer Center - La Jolla, La Jolla, California, United States

Kaiser Permanente Medical Center - Oakland, Oakland, California, United States

Kaiser Permanente Medical Center-Sacramento, Sacramento, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

Kaiser Permanente Medical Group - San Francisco, San Francisco, California, United States

Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States

Kaiser Permanente Medical Center - Vallejo, Vallejo, California, United States

University of Connecticut Health Center, Farmington, Connecticut, United States

Yale Comprehensive Cancer Center, New Haven, Connecticut, United States

Sylvester Cancer Center, University of Miami, Miami, Florida, United States

Adventist Health System/Sunbelt, Inc., Orlando, Florida, United States

Emory University School of Medicine, Atlanta, Georgia, United States

Lutheran General Cancer Care Center, Park Ridge, Illinois, United States

University of Louisville Hospital, Louisville, Kentucky, United States

Creighton University Cancer Center, Omaha, Nebraska, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico, United States

Interlakes Oncology/Hematology PC, Rochester, New York, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States

Christ Hospital, Cincinnati, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

Hematology Oncology Consultants Inc, Columbus, Ohio, United States

Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon, United States

Southwest Regional Cancer Center, Austin, Texas, United States

Contact Details

Name: Kenneth B. Von Eschen, PhD

Affiliation: GlaxoSmithKline

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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