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

Conditions: Melanoma (Skin)

Summary: rationale: vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells. purpose: phase ii trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.

objectives: * determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule. * determine the survival of infused cells with antitumor activity in these patients. outline: this is a salvage regimen. patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (til). cells are incubated in the presence of gp209-2m peptide and then harvested and cloned. patients receive 30-minute iv infusions of these in vitro sensitized cells. treatment repeats every 2 weeks for 2 courses. an additional cohort of 8 patients receives gp209-2m peptide in montanide isa-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. at 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated. patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (il-2) on one of two schedules. one cohort of patients receives il-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. another cohort receives il-2 by daily subcutaneous injections on days 1-12 of each course of therapy. if after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by il-2 on one of the two described schedules. patients are followed at 4-6 weeks. projected accrual: a total of 91 patients will be accrued for this study over 2 years.

Eligibility criteria:
disease characteristics: * histologically proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule * measurable or evaluable metastatic disease * must be hla-a201 positive by standard hla typing patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * greater than 3 months hematopoietic: * absolute neutrophil count greater than 1,000/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 * alt/ast less than 4 times upper limit of normal renal: * creatinine no greater than 1.6 mg/dl cardiovascular: * for patients randomized to receive interleukin-2: * no major medical illnesses of the cardiovascular system pulmonary: * for patients randomized to receive interleukin-2: * no major medical illnesses of the pulmonary system other: * hiv negative * hepatitis b antigen negative * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * for patients randomized to receive interleukin-2: * no active systemic infection * no other major medical illnesses of immune system * no coagulation disorders prior concurrent therapy: biologic therapy: * at least 4 weeks since prior biologic therapy chemotherapy: * at least 4 weeks since prior chemotherapy endocrine therapy: * no concurrent steroid therapy radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * not specified other: * no concurrent active treatment of brain metastases

Keywords: stage iv melanoma recurrent melanoma