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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
John M. Kirkwood, MD
Study Chair
University of Pittsburgh
United States: Federal Government
CDR0000068263
NCT00006385
September 2000
Name | Location |
---|---|
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 |