vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. it is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma. purpose: phase ii trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.

objectives: * compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (il-2). * compare the immune response in patients before and after treatment with these regimens. * compare the toxicity profile of these regimens in these patients. outline: this is a partially randomized study. patients are randomized to 1 of 3 treatment cohorts. * cohort 1: patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) iv once every 4 weeks for up to 4 doses. (closed to accrual as of 6/21/02.) * cohort 2: patients receive fowlpox vaccine intramuscularly (im) once every 4 weeks for up to 4 doses. (closed to accrual as of 6/21/04.) * cohort 3 (for patients in need of immediate interleukin-2 \[il-2\] and those with disease progression after treatment in cohorts 1 or 2): patients receive fowlpox vaccine either iv or im\* once every 4 weeks for 4 doses and il-2 iv every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. note: \*the im route of administration was selected as the preferred route of administration from cohorts 1 and 2 * expanded cohort 2 (open to accrual 7/19/02): patients receive fowlpox vaccine im once every 4 weeks for up to 4 doses. upon disease progression, patients receive fowlpox vaccine as above and il-2 iv every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. (closed to accrual 12/4/03.) in all cohorts, 3-4 weeks after the last injection, patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy. patients with responding disease may receive repeat vaccinations for up to 8 courses. patients with no response or progressive disease in cohorts not receiving il-2 may be treated with fowlpox vaccine and il-2 as in cohort 3. patients who are randomized to receive il-2 may not receive additional il-2 therapy. projected accrual: a maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and 27 in expanded cohort 2) will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically proven metastatic melanoma that has failed standard treatment * measurable disease * hla-a-201 positive patient characteristics: age: * 16 and over performance status: * ecog 0-2 life expectancy: * more than 3 months hematopoietic: * wbc ≥ 3,000/mm\^3 * platelet count ≥ 90,000/mm\^3 * no coagulation disorders hepatic: * bilirubin ≤ 1.6 mg/dl (less than 3.0 mg/dl for patients with gilbert's syndrome) * ast/alt \< 2 times normal * hepatitis b surface antigen negative renal: * creatinine ≤ 2.0 mg/dl cardiovascular: * no major cardiovascular disease * no cardiac ischemia by a stress thallium test or other comparable test\* * no myocardial infarction\* * no cardiac arrhythmias\* note: \*in order to be eligible to receive interleukin-2 (il-2) pulmonary: * no major respiratory disease * no obstructive or restrictive pulmonary disease\* note: \*in order to be eligible to receive il-2 immunologic: * no autoimmune disease * no known immunodeficiency disease * no primary or secondary immunodeficiency * no allergy to eggs * no active systemic infections * hiv negative other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception * no other active major medical illness\* note: \*in order to be eligible to receive il-2 prior concurrent therapy: biologic therapy: * no prior gp100 vaccination chemotherapy: * not specified endocrine therapy: * no concurrent steroids radiotherapy: * not specified surgery: * prior surgery for the malignancy allowed other: * at least 3 weeks since other prior therapy for the malignancy

Keywords: stage iv melanoma recurrent melanoma