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
- 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
- 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
- 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
PROJECTED ACCRUAL: A total of 92 patients (23 per arm) will be accrued for this study within
Allocation: Randomized, Primary Purpose: Treatment
John M. Kirkwood, MD
University of Pittsburgh
United States: Federal Government
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|Veterans Affairs Medical Center - Atlanta (Decatur)||Decatur, Georgia 30033|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Veterans Affairs Medical Center - Indianapolis (Roudebush)||Indianapolis, Indiana 46202|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|Cancer Center at the University of Virginia||Charlottesville, Virginia 22908|
|Veterans Affairs Medical Center - Madison||Madison, Wisconsin 53705|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|CCOP - Evanston||Evanston, Illinois 60201|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|CCOP - Marshfield Medical Research and Education Foundation||Marshfield, Wisconsin 54449|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|Tuft-New England Medical Center||Boston, Massachusetts 02111|
|Albert Einstein Clinical Cancer Center||Bronx, New York 10461|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|