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

Conditions: Stage IV Melanoma; Recurrent Melanoma

Summary: rationale: vaccines made from dna may make the body build an immune response to kill tumor cells. interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. combining vaccine therapy and interleukin-2 may kill more tumor cells. purpose: phase ii trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma that has not responded to previous treatment.

objectives: i. determine the clinical response of patients receiving dna gp100 antigen alone or in combination with interleukin-2 for recurrent metastatic melanoma. ii. identify the immunologic response in these patients prior to and after these treatments. iii. determine the toxicity of these treatments in these patients. protocol outline: patients are accrued for the first three cohorts and the study proceeds to the final two cohorts if responses are observed. cohort i: patients receive gp100 antigen intramuscularly (im) into each of 2 proximal extremities once every 4 weeks for up to 4 doses. (closed as of december, 1999) cohort ii: patients receive gp100 antigen intradermally (id) at 5 sites on each of 2 proximal extremities once every 4 weeks for up to 4 doses. (closed as of december, 1999) cohort iii: patients receive gp100 antigen im into each of 2 proximal extremities once every 4 weeks for up to 4 doses. if patients do not exhibit immunologic response or dose-limiting toxicity, they may receive a higher dose of gp100 antigen on subsequent courses. cohort iv: if cohorts i, ii, or iii do not produce an immune response and do not experience dose-limiting toxicity, patients receive a higher dose of gp100 antigen im into each of 2 proximal extremities every 4 weeks for up to 4 doses. cohort v: patients receive gp100 antigen im or id at the dose found to produce immunization once every 4 weeks for up to 4 doses. patients also receive interleukin-2 iv over 15 minutes every 8 hours for 5 days (15 doses), beginning within 24 hours after gp100 antigen. patients with minor, mixed, or partial response or stable disease may receive additional courses of treatment following 3-4 weeks of rest. patients receive a maximum of 12 courses. patients are followed at 4-6 weeks. projected accrual: a maximum of 65 patients will be accrued for this study within 1 year.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of metastatic melanoma that has failed standard therapy measurable disease --prior/concurrent therapy-- biologic therapy: at least 3 weeks since prior biologic therapy chemotherapy: at least 3 weeks since prior chemotherapy endocrine therapy: at least 3 weeks since prior endocrine therapy no concurrent steroid therapy radiotherapy: at least 3 weeks since prior radiotherapy surgery: prior surgery allowed --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 alt/ast less than 2 times normal hepatitis b surface antigen negative renal: creatinine no greater than 2.0 mg/dl cardiovascular: no major cardiovascular disease pulmonary: no major respiratory disease other: not pregnant negative pregnancy test fertile patients must use effective contraception no active systemic infections no autoimmune disease no primary or secondary immunodeficiency hiv negative

Keywords: adult solid tumor body system/site cancer cancer melanoma recurrent melanoma skin tumor solid tumor stage iv melanoma stage, melanoma