Vaccine Therapy in Treating Patients With Metastatic Melanoma
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.
|Melanoma (Skin)||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||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial|
|Study Start Date:||April 1999|
|Study Completion Date:||October 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003792
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Study Chair:||Joseph W. Fay, MD||Baylor Health Care System|