Melanoma (Skin) Clinical Trial
Official title:
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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