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A Randomized Phase II Trial of a Vaccine Combining Tyrosinase /gp100 Peptides Emulsified With Montanide ISA 51 Alone or With a Block Co-Polymer CRL 1005 or With GM-CSF for Patients With Resected Stages IIA and IIB Melanoma Grant Application Title: MART-1/gp100 Immune Responses to a Melanoma Vaccine
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known what preparation of vaccine therapy is most effective for treating melanoma. PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase/gp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery.
OBJECTIVES: I. Determine immune reactivity in HLA-A2 positive patients with resectable stage IIA or IIB melanoma treated with vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone or in combination with sargramostim (GM-CSF). OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIA vs IIB). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone subcutaneously (SQ) once a week on weeks 0, 2, 4, 6, 10, 14, 18, and 26. Arm II: Patients receive treatment as in arm I followed by sargramostim (GM-CSF) SQ for 5 days after each vaccination. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study within 3 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Start Date
March 1, 1998
Primary Completion Date
September 1, 2001
Completion Date
November 1, 2002
Last Updated
May 22, 2014
48
ACTUAL participants
gp100 antigen
BIOLOGICAL
incomplete Freund's adjuvant
BIOLOGICAL
sargramostim
BIOLOGICAL
tyrosinase peptide
BIOLOGICAL
Lead Sponsor
University of Southern California
Collaborators
NCT04079166
NCT04911998
Data Source & Attribution
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