Vaccine Therapy in Treating Patients With Metastatic Melanoma

Inclusion Criteria: 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