Spots Global Cancer Trial Database for Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
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Trial Identification
Brief Title: Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
Official Title: Phase II Evaluation of Immunization With an HLA-A2 Multi-Epitope Peptide Vaccine Containing MART-1 (NSC #672643), gp100 (NSC #683472), and Tyrosinase (NSC #699048) Peptides Alone or in Combination With GM-CSF, IFN Alpha-2b, or GM-CSF + IFN Alpha-2b in Patients With Metastatic Melanoma
Study ID: NCT00006385
Conditions
Study Description
Brief Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma. PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.
Detailed Description: OBJECTIVES: * Determine immune response of vaccination with melanoma associated antigens (MART-1:27-35, gp100:209-217 (210M), and tyrosinase:368-376 (370D)) on the number of peptide specific CD8+ T-cell precursors in HLA-A2 positive patients with metastatic melanoma. * Determine the influence of sargramostim (GM-CSF) and/or interferon alfa-2b (IFN-A) on the immune responses of these patients and toxicity of this melanoma peptide vaccine. * Determine any antitumor and anti-pigmentary response that may result from immunization against MART-1, gp100 and tyrosinase peptides, and determine the relationship between such clinical observations and immune responses against lineage antigens with or without GM-CSF and/or IFN-A. * Compare the relapse free survival and overall survival of patients treated with melanoma peptide vaccine alone or in combination with GM-CSF and/or IFN-A. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive multiepitope peptide (MEP) vaccine comprising MART-1:27-35, gp100:209-217 (210M), and tyrosinase:368-376 (370D) peptides. Each peptide is separately emulsified in Montanide ISA-51 and administered subcutaneously (SC) (for a total of 2 injections per peptide) on days 1 and 15. * Arm II: Patients receive MEP vaccine as in arm I and sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-14. * Arm III: Patients receive MEP vaccine as in arm I and interferon alfa-2b SC three times a week. * Arm IV: Patients receive MEP vaccine as in arm I, GM-CSF as in arm II, and interferon alfa-2b as in arm III. Treatment continues every 4 weeks for a maximum of 13 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 92 patients (23 per arm) will be accrued for this study within 13-16 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Tuft-New England Medical Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Albert Einstein Clinical Cancer Center, Bronx, New York, United States
Ireland Cancer Center, Cleveland, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States
Contact Details
Name: John M. Kirkwood, MD
Affiliation: University of Pittsburgh
Role: STUDY_CHAIR
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