Vaccine Therapy in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00003792|
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial|
|Study Start Date :||April 1999|
|Study Completion Date :||October 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003792
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Study Chair:||Joseph W. Fay, MD||Baylor Health Care System|