Immunization of Patients With Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic melanoma that has failed standard treatment

- No ocular or mucosal melanoma as primary site

- Measurable disease

- No existing brain metastases

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- ECOG 0 or 1

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm3

- Platelet count at least 90,000/mm3

- No coagulation disorder

Hepatic:

- Bilirubin no greater than 1.6 mg/dL

- AST/ALT less than 3 times normal

- Hepatitis B surface antigen negative

Renal:

- Creatinine no greater than 1.6 mg/dL

Cardiovascular:

- No major cardiovascular illness

Pulmonary:

- No major respiratory illness

Immunologic:

- HIV negative

- No autoimmune disease

- No primary or secondary immunodeficiency

- No allergy to eggs

- No history of allergy or untoward reaction to prior smallpox vaccination

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be able to avoid close contact with children under 5 years, pregnant women,
people with active or a past history of eczema or other eczematoid skin disorders,
and immunosuppressed people for at least 2 weeks after each vaccinia virus
vaccination

- No active systemic infections

- No active atopic dermatitis or active or past history of eczema

- No concurrent active extensive psoriasis, severe acneiform rash, impetigo, varicella
zoster, burns, or other traumatic or pruritic skin conditions or open wounds

- Surgical scars must be healed

- Healed surgical stomas (e.g., colostomy) allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior recombinant vaccinia or fowlpox vaccines for melanoma

- At least 3 weeks since prior systemic biologic therapy for melanoma

Chemotherapy:

- At least 3 weeks since prior systemic chemotherapy for melanoma

Endocrine therapy:

- At least 3 weeks since prior systemic endocrine therapy for melanoma

- No concurrent steroid therapy

Radiotherapy:

- At least 3 weeks since prior systemic radiotherapy for melanoma

Surgery:

- Prior surgery allowed