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Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial (NCT00003792)

National Cancer Institute (NCI)
RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
  • Biological: MART-1 antigen
    • Biological: filgrastim
      • Biological: flu matrix peptide p58-66
        • Biological: gp100 antigen
          • Biological: recombinant MAGE-3.1 antigen
            • Biological: tyrosinase peptide
              • Procedure: in vitro-treated peripheral blood stem cell transplantation
                Ages eligible for Study
                18 Years to 80 Years
                Genders eligible for Study
                Accepts Healthy Volunteers
                OBJECTIVES: I. Determine the safety and tolerability of antigen pulsed dendritic cell therapy in patients with metastatic melanoma. II. Perform serial analysis of T cell and B cell function in these patients after this treatment. III. Determine objective response and response duration in these patients after this treatment.

                OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days 1-6, then undergo leukapheresis for 2-3 days, beginning on day 6. Mononuclear cells are selected for CD34+ cells in the laboratory, made into dendritic cells, and then pulsed with MART-1, gp100, tyrosinase, MAGE-3 peptides and flu matrix. These antigen pulsed dendritic cells (ApDCs) are used for vaccinations. Prior to vaccination, ApDCs are mixed with MART-1, gp100, tyrosinase, MAGE-3, and flu matrix. Patients receive this dendritic cell vaccine mixture SQ every 2 weeks for 4 priming doses. Patients receive 4 boost vaccinations SQ at 2 months, 5 months, 9 months, and 15 months following the last priming vaccination. Patients are followed monthly for 2 years.

                PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

                1 locations

                United States (1)
                • Baylor University Medical Center
                  Not specified
                  Dallas, Texas, United States, 75246
                31 March, 1999
                24 June, 2013
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