Finding studies
Finding studies
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Lead
Craig L Slingluff, Jr
With
OBJECTIVES: * Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim (GM-CSF). * Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site. * Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites. * Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site. * Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF at 2 injection sites. In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster vaccinations at weeks 12, 26, 39, and 52. PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
