RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
OBJECTIVES: * Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF). OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43. * Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. * Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine. PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Safety: Dose-limiting toxicity
Toxicities measured by CTCAE.
Time frame: During study period
Immunogenicity
Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.
Time frame: day 22
Immune response in the blood
Immune response measured in the blood, by proliferation assay, over time during the study.
Time frame: day 50
DTH response
Delayed-type hypersensitivity response to tumor peptides
Time frame: by day 85
Clinical outcome
Clinical tumor response
Time frame: during the study
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