Vaccine Therapy in Treating Patients With Metastatic Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma
• Lesion(s) must be accessible to percutaneous injection
• Measurable lesion(s)
• * At least 1.0 cm
• Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed
• * At least 6 weeks since prior definitive therapy (surgery or radiotherapy)
• No untreated or edematous metastatic brain lesions or leptomeningeal disease
• No ascites or pleural effusions
• PATIENT CHARACTERISTICS:
• Age:
• Over 18
• Performance status:
• ECOG 0-1
• Life expectancy:
• More than 3 months
• Hematopoietic:
• WBC at least 3,000/mm3
• Platelet count at least 100,000/mm3
• Absolute granulocyte count at least 3,000/mm3
• Hemoglobin at least 10 g/dL
• Hepatic:
• Direct bilirubin no greater than 1.5 mg/dL
• Transaminases no greater than 2 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2 times ULN
• No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications)
• No hepatic insufficiency
• No alcoholic cirrhosis
• Renal:
• Creatinine no greater than 2.0 mg/dL OR
• Creatinine clearance at least 60 mL/min
• No renal insufficiency
• Cardiovascular:
• No congestive heart failure
• No serious cardiac arrhythmias
• No evidence of recent prior myocardial infarction on EKG
• No clinical coronary artery disease
• Pulmonary:
• No chronic obstructive pulmonary disease
• Immunologic:
• No prior eczema
• HIV negative
• No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds)
• No clinical or laboratory evidence of an underlying immunosuppressive disorder
• No active or chronic infections
• No significant allergy or hypersensitivity to eggs
• Other:
• No active seizure disorders
• No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free
• No evidence of bone marrow toxicity
• No other concurrent medical illness that would preclude study
• No other contraindications to vaccinia virus administration
• No encephalitis
• Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Prior vaccinia immunization required (e.g., smallpox vaccination)
• More than 8 weeks since prior immunotherapy and recovered
• No prior therapy with live vaccinia virus vector
• Chemotherapy:
• More than 4 weeks since prior chemotherapy and recovered
• Endocrine therapy:
• At least 4 weeks since prior systemic corticosteroids
• No concurrent systemic corticosteroids
• No concurrent steroids
• Radiotherapy:
• See Disease Characteristics
• More than 2 weeks since prior radiotherapy and recovered
• Surgery:
• See Disease Characteristics
• More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered
• Other:
• No concurrent immunosuppressive drugs