Vaccine Therapy With or Without Recombinant Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma

PRIMARY OBJECTIVES: I. To determine if admixture of IL-12 (recombinant interleukin-12) with vaccine emulsion will increase the frequency of vaccine-induced cluster of differentiation (CD)8+ T cells in the blood. II. To determine if administration of daclizumab will deplete CD4+CD25+ regulatory T cells from the peripheral and potentiate specific immune responses induced by vaccination. III. To determine if vaccination +/- daclizumab will be safe in this patient population. SECONDARY OBJECTIVES: I. To determine if vaccination +/- daclizumab will have clinical activity in patients with advanced melanoma. II. To determine if clinical response may be associated with particular gene expression profiles in the tumor microenvironment. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive multipeptide vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 intradermically (ID) or subcutaneously (SC) on days 1, 22, and 50. ARM II: Patients receive vaccination as in arm I with an admixture of recombinant interleukin-12 (IL-12) on days 1, 22, and 50. In both arms, patients are evaluated for immune response. Patients with partial response or stable disease may be immunized for up to a maximum of 1 year. Patients with complete response may be treated with 1 additional course of 3 vaccinations. EXPANDED COHORT: Additional patients are accrued to the arm with higher immune response and receive daclizumab IV over 15 minutes on day -7. Patients then receive vaccination as in arm I or arm II on days 1, 22, and 50 in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 8 weeks until disease progression and then at least every 3 months thereafter.