Melanoma (Skin) Clinical Trial
Official title:
B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the
ability of tumor cells to grow and spread. Others find tumor cells and help kill them or
carry tumor-killing substances to them.
PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal
antibody 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.
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