Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Condition: Intraocular Melanoma; Melanoma (Skin)
MeSH terms: Melanoma
Intervention: mouse gp100 plasmid DNA vaccine; The Dermal PowderMed® devices; intramuscularly (IM injection)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 1 Year
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma; ciliary body and choroid melanoma, medium/large size; ciliary body and choroid melanoma, small size; recurrent intraocular melanoma; metastatic intraocular melanoma

Summary:

      RATIONALE: Vaccines made from DNA may help the body build an effective immune response to
      kill tumor cells. Giving the vaccine in different ways may make a stronger immune response
      and kill more tumor cells.

      PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine
      therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage
      III, or stage IV melanoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed malignant melanoma

               -  Stage IIB, IIC, III, or IV disease

                    -  Patients free of disease after surgical resection must meet 1 of the
                       following criteria:

                         -  Refused high-dose interferon alfa

                         -  Recurrence while on interferon alfa

                    -  Patients with stage IIB, IIC, or III disease must have already undergone
                       initial standard therapy (i.e., surgery) for the disease

          -  Choroidal (uveal) melanoma allowed provided 1 of the following criteria is met:

               -  Basal diameter > 16 mm

               -  Basal height > 8 mm

               -  Involvement of the ciliary body with tumor

          -  HLA-A*0201 positive

          -  Negative serum antidouble-stranded DNA antibody screen

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 80-100%

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  WBC ≥ 3,000/mm^3

          -  Lactic dehydrogenase ≤ 2 times upper limit of normal (ULN)

          -  Creatinine ≤ 2.0 mg/dL

          -  Bilirubin ≤ 2.5 times ULN

          -  Albumin ≥ 3.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Weight ≥ 25 kg

          -  No preexisting choroidal eye disease

          -  No serious underlying medical conditions that could be exacerbated by study
             participation (i.e., active infections requiring antimicrobial drugs or active
             bleeding)

          -  No allergy to gold (i.e., gold jewelry)

          -  No evidence of any condition at the proposed site(s) of vaccine administration that
             might interfere with the interpretation of local skin reactions, including any of the
             following:

               -  Damaged skin

               -  Moles

               -  Scars

               -  Tattoos

               -  Marks

          -  No prior medical condition or use of medication (e.g., corticosteroids) that might
             make it difficult for the patient to complete the full course of treatment or to
             respond immunologically to vaccines

          -  No history or evidence (within the past 5 years) of a physician-diagnosed chronic or
             recurrent inflammatory skin disease at the proposed site of vaccine administration,
             including any of the following:

               -  Psoriasis

               -  Eczema

               -  Atopic dermatitis

               -  Hypersensitivity

          -  No history of keloid formation

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 4 weeks since prior chemotherapy, immunotherapy, or radiotherapy (6 weeks for
             nitrosoureas) and recovered

          -  No prior immunization with any class of vaccine containing gp100 peptide

          -  No other concurrent investigational agents

          -  No other concurrent systemic therapy or radiotherapy