Phase Ib Trial of Intratumoral Injection of a Recombinant Canarypox Virus Encoding Human B7.1 (ALVAC-hB7.1) or a Combination of ALVAC-hB7.1 and a Recombinant Canarypox Virus Encoding Human Interleukin 12 (ALVAC-hIL-12) in Patients With Surgically Incurable Melanoma

Date de début de l'étude : 1 janvier 1999

DISEASE CHARACTERISTICS: Histologically confirmed melanoma that is surgically incurable At least one dermal, subcutaneous or lymph node metastasis that is evaluable for local response and accessible for injection If only one accessible lesion is available, it must be at least 2 cm If two or more accessible lesions exist, then none of them are required to be at least 2 cm PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Leukocyte count at least 3,000/mm3 Platelet count at least 120,000/mm3 SGOT and alkaline phosphatase less than 5 times normal Bilirubin less than 1.5 mg/dL (unless secondary to hepatic metastasis) BUN less than 40 mg/dL Creatinine less than 2.5 mg/dL No evidence of congestive heart failure, unstable angina, or serious cardiac arrhythmias Not positive for hepatitis B virus Not positive for HIV No history of allergy to vaccinia virus No evidence of other primary tumors except for basal cell carcinoma, squamous cell skin carcinoma, or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception No underlying immunodeficiency disorder PRIOR CONCURRENT THERAPY: At least 30 days since prior biologic therapy (e.g., interferon or IL-2) At least 30 days since prior chemotherapy No concurrent steroids At least 30 days since prior radiotherapy Prior radiotherapy to no greater than 50% of nodal groups No prior splenectomy No concurrent drugs which affect immune function (e.g., glucocorticoids or cimetidine)