Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

OBJECTIVES:

Primary

• Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.

Secondary

• Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.
• Determine the treatment impact on tumor growth (e.g., objective response, time to progression).

OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.

Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry.

After completion of study treatment patients are followed every 2 months for 5 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma

• Stage IV disease (M1a and M1b only)
• Measurable disease according to RECIST criteria
• HLA-A2 positive
• Must have IgA in serum (any concentration)
• No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Hemoglobin ≥ 10.0 g/dL
• Platelet count ≥ 75,000/mm^3
• AST ≤ 5 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to provide informed consent
• Agrees to return to Mayo Clinic Rochester for follow-up
• Agrees to participate in the mandatory translational research component of the study
• No uncontrolled or current infection
• No known immune deficiency
• No B or AB blood grouping

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior chemotherapy and recovered
• More than 4 weeks since prior biologic therapy
• No concurrent immunosuppressive therapy