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

Conditions: Melanoma (Skin)

Summary: rationale: vaccines made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. interleukin-2 may stimulate a person's white blood cells to kill tumor cells. combining vaccine therapy with interleukin-2 may kill more melanoma cells. purpose: this phase i/ii trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy.

objectives: * evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of immunization with dendritic cells presenting the mart-1 and gp100 melanoma antigens with or without interleukin-2 in patients with metastatic melanoma. outline: this is a dose-escalation study of dendritic cells pulsed with mart-1 and gp100 antigens. patients receive vaccinations with dendritic cells pulsed with mart-1 and gp100 antigens, either intralymphatically every 4 weeks for 2 doses, or iv every 3 weeks for 4 doses. some patients also receive interleukin-2 subcutaneously or iv, over 3-5 days, beginning 24 hours after immunization. cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells iv until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. subsequent cohorts receive cells with or without interleukin-2. one cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine. one cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4 weeks for 2 courses. patients with stable disease or who achieve minor, mixed, or partial response may be retreated. patients with stable or responding disease undergo a second course of vaccination. patients who completed treatment with vaccine alone and have stable disease, progressive disease, disease progression after a response, or a partial response with no further improvement may receive 2 additional courses. projected accrual: a total of 10-42 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic melanoma that has failed standard effective therapy * measurable or evaluable disease * hla-a2 positive patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * more than 3 months hematopoietic: * wbc greater than 3,000/mm\^3 * platelet count greater than 100,000/mm\^3 * hemoglobin greater than 8.0 g/dl hepatic: * bilirubin no greater than 2.0 mg/dl * ast/alt less than 4 times upper limit of normal * negative hepatitis b surface antigen * no coagulation disorder renal: * creatinine no greater than 1.6 mg/dl or * creatinine clearance greater than 75 ml/min cardiovascular: * no major cardiovascular disease pulmonary: * no major respiratory disease other: * no major immunological disease * no penicillin allergy * hiv negative * no active systemic infection * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * at least 4 weeks since prior steroid therapy and recovered radiotherapy * not specified surgery * not specified other * more than 4 weeks since any other prior therapy and recovered

Keywords: recurrent melanoma