Trials / Completed
CompletedNCT00003792
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Baylor Health Care System · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 1999-04-01
- Completion
- 2006-10-01
- First posted
- 2004-07-16
- Last updated
- 2013-06-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00003792. Inclusion in this directory is not an endorsement.