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