Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003792
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
Baylor Health Care System
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a persons 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T98-0054 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066935 | REGISTRY | None | None |