Melanoma (Skin) Clinical Trial
Official title:
Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial
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.
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.
;
Primary Purpose: Treatment
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