Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
Condition: Intraocular Melanoma; Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells. Vaccines may make the body
      build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51
      may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody
      therapy together with vaccine therapy may be an effective treatment for stage III or stage IV
      melanoma.

      PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together
      with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Achieve at least a 40% autoimmune breakthrough event rate, as defined by the induction
           of grade 1, grade 2, or acceptable grade 3 drug-related autoimmune adverse events, in
           patients with resected stage III or IV melanoma treated with anti-cytotoxic
           T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) and peptide vaccine
           comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51.

      Secondary

        -  Determine the incidence of drug-related autoimmune adverse events of any grade in
           patients treated with this regimen.

        -  Determine the time to disease relapse in patients treated with this regimen.

        -  Determine the immunologic response in patients treated with this regimen.

      OUTLINE: This is an open-label study.

      Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
      (MDX-010) IV over 90 minutes on day 1 of weeks 1, 9, 17, 25, 33, 41, and 53 and peptide
      vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide
      ISA-51 subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53.

      Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
    

Intervention name(s): ipilimumab; Tyrosinase/gp100/MART-1 Peptides
Intervention type(s): Biological; Biological
Intervention description(s): IV over 90 mins on day 1, wks 1,9,17,25,33,41,53 Dose: 3 mg/kg (Part I), 10 mg/kg (Part II); (All subjects in Part I and HLA-A*0201 positive subjects only in Part II): SC, day 1 of wks 1,3,5,7,9,11,17, 21,25,33,41,53 Dose: 1 mg peptide emulsified in 1 mL Montanide ISA 51 VG.)
Intervention MeSH terms: Ipilimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III melanoma; stage IV melanoma; ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; iris melanoma; recurrent melanoma; recurrent intraocular melanoma; metastatic intraocular melanoma