vaccine therapy and interleukin-2 in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: vaccines may make the body build an immune response that will kill tumor cells. interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. purpose: phase ii trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma.

objectives: * determine the response rate (partial response or complete remission) in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine, fowlpox-tyrosinase vaccine, and high-dose interleukin-2. * determine the immunologic response, measured by the reactivity of cd4+ and cd8+ t cells and serum immunoglobulins against tyrosinase and melanoma cells, in patients treated with this regimen. outline: patients receive vaccinia-tyrosinase vaccine intramuscularly (im) on day 1 followed by fowlpox-tyrosinase vaccine im on days 15 and 29. patients then receive high-dose interleukin-2 (il-2) iv over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose. patients with stable disease or a minor, mixed, or partial response may receive additional courses of fowlpox-tyrosinase vaccine (2 doses) and il-2 as above in the absence of disease progression or unacceptable toxicity. patients with a complete response (cr) receive 1 additional course beyond achieving cr. patients are followed annually for at least 5 years. projected accrual: a total of 19-35 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * diagnosis of metastatic melanoma * measurable disease * disease progression while receiving prior standard treatment * no ocular or mucosal primary site * no uncontrolled brain metastases patient characteristics: age * 16 and over performance status * ecog 0-1 life expectancy * more than 3 months hematopoietic * wbc at least 3,000/mm\^3 * platelet count at least 90,000/mm\^3 * no coagulation disorders hepatic * bilirubin no greater than 1.6 mg/dl (less than 3.0 mg/dl in patients with gilbert's syndrome) * ast/alt less than 3 times normal * hepatitis b surface antigen negative * hepatitis c antibody 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 active systemic infections * no primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or wiskott-aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation) * no allergy to eggs * no prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated) other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no close contact with the following individuals for 2 weeks after vaccinia vaccination: * children under 5 years of age * pregnant women * individuals with prior or active eczema or other eczematoid skin disorders * individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) * immunosuppressed individuals * no active atopic dermatitis * no prior or active eczema * no active cases of the following conditions: * extensive psoriasis * severe acneiform rash * impetigo * varicella zoster * burns * traumatic or pruritic skin conditions * open wounds * no unhealed surgical scars * healed surgical stomas (e.g., colostomy) allowed prior concurrent therapy: biologic therapy * no prior recombinant vaccinia or fowlpox vaccines for melanoma * no prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma * prior individual tyrosinase peptides are allowed * no prior high-dose interleukin-2 chemotherapy * not specified endocrine therapy * no concurrent oral, iv, topical, or inhaled steroids radiotherapy * not specified surgery * recovered from prior surgery other * recovered from prior therapy for melanoma * more than 3 weeks since prior systemic therapy for melanoma * no other concurrent systemic therapy for melanoma

Keywords: stage iv melanoma recurrent melanoma