vaccine therapy in treating patients with stage iii or stage iv melanoma

Conditions: Melanoma (Skin)

Summary: rationale: vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. purpose: this phase i trial is studying the side effects and best dose of vaccine therapy in treating patients with stage iii or stage iv melanoma.

objectives: primary * determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage iii or iv melanoma. * determine the safety and tolerability of this therapy in these patients. secondary * determine the immune response, in terms of the type and degree of t-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy. outline: this is a dose-escalation, pilot study. patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (pbmc) on days -9, 19, and 47. autologous dendritic cells (dc) are prepared from autologous pbmc exposed to sargramostim (gm-csf), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. patients receive autologous tumor cell lysate-pulsed dc iv over 5-10 minutes on days 0, 28, and 56. cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed dc until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which 33% of all patients experience dose-limiting toxicity. patients are followed at day 84 and then every 3 months thereafter. projected accrual: a total of 3-20 patients will be accrued for this study within 3-20 months.

Eligibility criteria:
disease characteristics: * histologically confirmed melanoma * stage iii (lymph node or in-transit metastases) or iv (systemic metastases) disease * patients with relapsed disease or who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease) * tumor tissue available and properly stored for lysate preparation patient characteristics: age * 18 and over performance status * karnofsky 60-100% life expectancy * at least 12 weeks hematopoietic * absolute neutrophil count ≥ 1,000/mm\^3 * platelet count ≥ 75,000/mm\^3 hepatic * ast ≤ 2 times upper limit of normal (uln) (3 times uln for liver metastases) * bilirubin ≤ 2 times uln * hepatitis b surface antigen negative * hepatitis c negative renal * creatinine ≤ 2.0 times uln immunologic * no active infection * no history of autoimmune disease, including any of the following: * inflammatory bowel disease * systemic lupus erythematosus * scleroderma * rheumatoid arthritis * multiple sclerosis * no allergy to aminoglycosides or streptomycin * hiv negative other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no significant comorbid illness * no other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy * see disease characteristics * at least 10 days since prior immunotherapy chemotherapy * see disease characteristics endocrine therapy * at least 6 weeks since prior steroid therapy * no concurrent corticosteroids radiotherapy * at least 10 days since prior radiotherapy * no concurrent radiotherapy surgery * at least 10 days since prior surgery * prior diagnostic or palliative surgery allowed provided the patient has fully recovered other * no concurrent immunosuppressive or potentially immunosuppressive therapy

Keywords: recurrent melanoma stage iii melanoma stage iv melanoma