Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically proven metastatic, unresectable melanoma Dermal, subcutaneous, or lymph node metastases
• Accessible for injection
• Lesions must measure at least 1 cm
• Patients with no prior treatment allowed
• Patients must have one of the following as proof of prior vaccinia immunization:
• * Physician certification
• * Recollection and appropriate vaccination scar site
• * No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease
• * No ascites or pleural effusions
• * No leukemia or lymphoma
• PATIENT CHARACTERISTICS:
• Age: Over 18
• Performance status: ECOG 0-1 Karnofsky 80-100%
• Life expectancy: Greater than 3 months
• WBC greater than 4,000/mm3
• Platelet count greater than 100,000/mm3
• Hemoglobin greater than 10g/dL
• Bilirubin less than 1.5 mg/dL
• Transaminases no greater than 2 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2 times ULN
• PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications
• No alcoholic cirrhosis
• Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min
• No congestive heart failure
• No serious cardiac arrhythmias
• No recent prior myocardial infarction
• No clinical coronary artery disease
• No chronic obstructive pulmonary disease
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No seizure disorders
• No underlying immunosuppressive disorder
• No autoimmune disease HIV negative
• No skin diseases
• No open wounds
• No eczema or other contraindications to vaccinia virus administration
• Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment
• No significant allergy or hypersensitivity to eggs
• No active or chronic infections
• No concurrent medical illness
• No other significant medical disease which would increase risk to patient
• No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma
• PRIOR CONCURRENT THERAPY:
• At least 8 weeks since prior immunotherapy and recovered
• No prior live pox virus vector
• No more than 2 prior chemotherapy regimens
• At least 4 weeks since prior chemotherapy and recovered
• At least 4 weeks since prior systemic corticosteroids
• No systemic corticosteroids for concurrent illness
• No concurrent immunosuppressive steroids
• At least 2 weeks since prior radiotherapy and recovered (no bone marrow toxicity)
• At least 6 months since prior radiotherapy for brain metastases and recovered
• At least 4 weeks since prior surgery for management of the primary or metastatic lesions and recovered with remaining measurable disease
• At least 6 months since prior surgery for brain metastases and recovered
• No concurrent immunosuppressive drugs