vaccine therapy in treating patients with metastatic melanoma

Conditions: Intraocular Melanoma; Melanoma (Skin)

Summary: rationale: vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells. purpose: this phase ii trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

objectives: primary * determine clinical response in hla-a \*0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with mart-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail. secondary * determine immunologic response in patients treated with this regimen. outline: this is a multicenter study. patients undergo apheresis to collect dendritic cells (dc). autologous dc are pulsed ex vivo with tumor antigen peptides derived from mart-1: 26-35 (27l), gp100: 209-217 (210m), and tyrosinase: 368-376 (370d) and matured with a cytokine cocktail comprising interleukin (il)-4, il-6, il-1β, sargramostim (gm-csf), tumor necrosis factor-α, and prostaglandin e2. patients receive 12 intradermal injections of dc vaccine over 30 minutes on days 1, 8, 22, and 36. treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically until disease progression. projected accrual: a total of 41 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of melanoma * metastatic disease * the following melanoma subtypes are eligible: * unresectable, stage iii-iv uveal melanoma * metastatic mucosal melanoma * measurable disease after attempted curative surgical therapy * tumor tissue must be available for immunohistochemical staining * positive for ≥ 1 of the following peptides: * mart-1: 26-35 (27l) * gp100: 209-217 (210m) * tyrosinase: 368-376 (370d) * hla-a \*0201 positive by dna polymerase chain reaction assay patient characteristics: * ecog performance status (ps) 0-1 or karnofsky ps 70-100% * creatinine ≤ 2.0 mg/dl * bilirubin ≤ 2.0 mg/dl * wbc ≥ 3,000/mm\^3 * platelet count ≥ 75,000/mm\^3 * hemoglobin ≥ 9.0 g/dl * no major systemic infections * no coagulation disorders * no major medical illness of the cardiovascular or respiratory system * no myocardial infarction within the past 6 months * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no known hiv positivity * no know positivity for hepatitis b surface antigen or hepatitis c antibody * no prior uveitis or autoimmune inflammatory eye disease * no other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated \> 5 years ago and has no detectable disease prior concurrent therapy: * see disease characteristics * no more than 1 prior cytotoxic chemotherapy agent or regimen * prior biologic or antiangiogenic therapies allowed * more than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma * no prior mart-1: 26-35 (27l), gp100: 209-217 (210m), or tyrosinase: 368-376 (370d) peptides * no concurrent steroid therapy

Keywords: recurrent melanoma stage iv melanoma ciliary body and choroid melanoma, medium/large size iris melanoma recurrent intraocular melanoma extraocular extension melanoma