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

Inclusion Criteria

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)