Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells

Date de début de l'étude : 1 juin 2004

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