vaccine therapy in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells. purpose: phase i trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

objectives: * determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma. * determine the longevity of melanoma-specific immunity in patients treated with this regimen. * perform serial analysis of t-cell and b-cell function in patients treated with this regimen. outline: patients receive filgrastim (g-csf) subcutaneously (sc) once daily on days 1-6 or 1-7. patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (pbmc). pbmc are processed for cd34+ cell isolation. these autologous cd34+ hematopoietic progenitor cells are cultured to generate dendritic cells (dc). dc are then pulsed with endotoxin-free keyhole limpet hemocyanin and hla-a2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (mart-1:27-35, gp100:209-217, and mage-3). antigen-pulsed dc are incubated with interferon alfa to induce dc maturation. patients receive priming injections of antigen-pulsed dc vaccine sc once every 2 weeks for 8 weeks. treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression. patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years. projected accrual: a total of 18 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic melanoma * hla-a2-01 phenotype * measurable disease * no active cns or hepatic metastases patient characteristics: age: * 21 and over performance status: * karnofsky 80-100% life expectancy: * not specified hematopoietic: * not specified hepatic: * see disease characteristics * no viral hepatitis renal: * not specified cardiovascular: * no prior venous thrombosis, angina pectoris, or congestive heart failure * lactate dehydrogenase less than 2 times normal pulmonary: * no prior asthma immunologic: * intradermal skin test positivity to mumps, candida, or streptokinase antigen * no known sensitivity to e. coli drug preparations * no prior allergy to influenza vaccine * no active infection * no prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis) other: * hiv negative * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 8 weeks since prior interleukin-2 * at least 4 weeks since prior interferon alfa chemotherapy: * at least 8 weeks since prior chemotherapy endocrine therapy: * at least 2 weeks since prior corticosteroids * no concurrent corticosteroids radiotherapy: * not specified surgery: * not specified other: * no concurrent immunosuppressive agents * at least 2 weeks since prior immunosuppressive agents

Keywords: stage iv melanoma recurrent melanoma