Vaccine Therapy in Treating Patients With Melanoma

OBJECTIVES:

I. Determine the toxic effects associated with ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 in patients with surgically incurable melanoma.

II. Characterize the inflammatory and lymphokine response to this regimen in these patients.

III. Examine the extent of nodule regression, humoral immune response, and cytolytic T cell activity with this regimen in these patients.

OUTLINE: This is a dose escalation study of ALVAC-hB7.1

Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity.

Patients are followed at 1, 2, 4, 8, 11, 15, 22, and 43 days after the first vaccination.

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)