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
Intervention: ipilimumab; Tyrosinase/gp100/MART-1 Peptides
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed melanoma

               -  Stage III (≥ 3 positive lymph nodes) or stage IV disease

               -  Mucosal or ocular melanoma allowed

          -  Completely resected within the past 6 months

          -  Patients with stage III resected melanoma rendered free of disease may have failed,
             been ineligible for, or refused prior treatment with interferon alfa

          -  Positive staining of tumor tissue for at least one of the following:

               -  Antibody HMB-45 for gp100

               -  Antibody HMB-45 for tyrosinase

               -  Antibody HMB-45 for MART-1

          -  HLA-A*0201 positive by DNA allele-specific polymerase chain reaction assay

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  At least 6 months

        Hematopoietic

          -  WBC ≥ 2,500/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hematocrit ≥ 30%

          -  Hemoglobin ≥ 10 g/dL

        Hepatic

          -  AST ≤ 3 times upper limit of normal (ULN)*

          -  Bilirubin ≤ ULN* (< 3.0 mg/dL for patients with Gilbert's syndrome)

          -  No significant hepatic disease that would preclude study participation

          -  Hepatitis B surface antigen negative

          -  Hepatitis C antibody negative NOTE: * Unless attributable to disease

        Renal

          -  Creatinine ≤ 2.0 mg/dL

          -  No significant renal disease that would preclude study participation

        Cardiovascular

          -  No significant cardiac disease that would preclude study participation

        Pulmonary

          -  No significant pulmonary disease that would preclude study participation

        Immunologic

          -  No history of any of the following:

               -  Inflammatory bowel disease or any other autoimmune bowel disease

               -  Systemic lupus erythematosus

               -  Rheumatoid arthritis

               -  Autoimmune ocular disease

          -  No systemic hypersensitivity to Montanide ISA-51 or any vaccine component

          -  No active infection requiring therapy

          -  HIV negative

        Other

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the
             cervix

          -  No significant gastrointestinal disease that would preclude study participation

          -  No significant psychiatric disease that would preclude study participation

          -  No other medical condition that would preclude study participation

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 4 months
             after study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

          -  No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
             (MDX-010)

          -  No prior gp100 antigen, MART-1 antigen, or tyrosinase peptide

          -  At least 4 weeks since prior immunotherapy for melanoma and recovered

          -  No other concurrent immunotherapy

        Chemotherapy

          -  At least 4 weeks since prior chemotherapy for melanoma (6 weeks for nitrosoureas) and
             recovered

          -  No concurrent chemotherapy

        Endocrine therapy

          -  At least 4 weeks since prior hormonal therapy for melanoma and recovered

          -  At least 4 weeks since prior systemic, inhaled, or topical corticosteroids

          -  No concurrent systemic, inhaled, or topical corticosteroids

        Radiotherapy

          -  At least 4 weeks since prior radiotherapy for melanoma and recovered

        Surgery

          -  See Disease Characteristics

          -  At least 4 weeks since prior surgery for melanoma and recovered

        Other

          -  No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)

          -  Concurrent analgesic therapy allowed provided the dose is stable for the past 14 days