Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

Upon entry into the study, patients randomized to the dendritic cell arm will undergo a complete baseline evaluation and leukapheresis 0.5 to 3 x 106 DCs per peptide antigen (total not to exceed 18 x 106 cells) will be administered intradermally as per injection SOP. They will receive up to 3 booster DC injections (total not to exceed 18 x 10 6 cells per injection) at monthly intervals for a total of 4 injections. The booster injections will not contain KLH, as our volunteer studies have shown that priming occurs following a single injection of DCs

Patients randomized to the Montanide arm will also undergo complete baseline evaluation but not leukapheresis. The peptides will be mixed with the adjuvant, Montanide, and administered subcutaneously at a dose of 100 microgram of each peptide +100 microgram KLH mixed with an equal volume of Montanide. They will receive up to 3 booster injections at monthly intervals for a total of 4 injections. The booster injections will not contain KLH.