Vaccine Therapy in Treating Patients With Metastatic Melanoma

You may be eligible if

• Histologically or cytologically confirmed melanoma
• * Stage IV disease
• Measurable disease
• * At least 1 cutaneous or lymph node mass ≥ 1 cm AND amenable to biopsy and percutaneous injection AND can be accurately measured with standard calipers
• Must be tested for expression of HLA-A2 prior to study
• Must have 1 of the following criteria:
• * Circulating melanoma-specific CD8-positive T cells against ≥ 1 defined antigen (Melan-A, gp100 antigen, tyrosinase, MAGE-A10, Trp-2, or NA17) as measured by tetramer or ELISpot directly ex-vivo or after a 10 day in vitro expansion
• * Detectable intratumoral T cells measured in the index lesion that is to be injected with rF-TRICOMTM by immunohistochemistry (IHC) for CD4, CD8 or another T cell marker, or by real time RT-PCR for CD8a, CD4, or other T cell transcripts
• No untreated or edematous brain metastases or leptomeningeal disease
• * Treated CNS disease allowed provided patient remains stable off corticosteroid therapy
• Performance status - Karnofsky 70-100%
• More than 12 weeks
• WBC ≥ 3,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No uncontrolled bleeding disorder that would increase the risk of bleeding from the injected lesion
• No active thrombotic thrombocytopenic purpura within the past 2 years
• PT/PTT ≤ 1.25 times upper limit of normal (ULN)
• AST and ALT ≤ 1.5 times ULN
• Bilirubin ≤ 1.5 times ULN
• No chronic hepatitis B or C
• Creatinine ≤ 2.0 mg/dL
• Creatinine clearance ≥ 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• HIV negative
• No prior significant allergic reaction or hypersensitivity to eggs or egg products
• No disease that limits the function of the spleen (e.g., sickle cell disease)
• No uncontrolled active or chronic infection
• No active autoimmune disorders or disease
• No immunosuppression, defined as concurrent or possible requirement for systemic corticosteroids
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 4 weeks after study participation
• Able to avoid direct contact of the immunization site with the following individuals:
• * Children \< 3 years of age
• * Immunocompromised individuals (including those on systemic corticosteroids)
• * Pregnant women
• * Individuals with extensive skin disease
• No active seizure disorder
• No skin disease and/or open unhealing wounds
• No psychiatric illness or social situation that would preclude study compliance
• No other significant medical illness that would significantly increase the risk associated with immunotherapy
• No other active malignancy requiring concurrent therapy except squamous cell or basal cell skin cancer or undetectable hormone-responsive prostate cancer (as measured by normal prostate-specific antigen)
• No other concurrent uncontrolled illness that would preclude study participation
• No prior fowlpox virus-based therapy
• No prior B7-1, intercellular adhesion molecule-1 (ICAM-1), or leukocyte function-associated antigen-3 (LFA-3)
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• See Disease Characteristics
• Concurrent adjuvant hormonal therapy for early-stage or high-risk breast cancer allowed
• No concurrent corticosteroids
• More than 2 weeks since prior radiotherapy and recovered
• More than 2 weeks since prior surgery and recovered
• No prior splenectomy
• No concurrent therapeutic anticoagulation therapy that would increase the risk of bleeding from injected lesion
• No other concurrent immunosuppressive drugs
• No other concurrent investigational agents
• No other concurrent anticancer therapy