Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003432
Status:
TERMINATED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Immunotherapy in Treating Patients With Metastatic Breast Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase III Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed Autologous Cultured Dendritic Cells for Patients With Breast Cancer Who Achieve a Complete Response After High Dose Chemotherapy and Stem Cell Support
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Immunotherapy using CEA-treated white blood cells may help a persons body build an immune response to and kill their tumor cells
PURPOSE Phase III trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation
PURPOSE Phase III trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation
Detailed Description:
OBJECTIVES
Evaluate the ability of active immunotherapy with carcinoembryonic antigen CEA RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant
Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population
OUTLINE Dendritic cells are taken from the leukapheresis product obtained during the peripheral blood stem cell transplant procedure performed prior to treatment on this study The dendritic cells are pulsed with carcinoembryonic antigen CEA RNA Approximately 60-90 days after the peripheral blood stem cell transplant patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses Patients undergo a second leukopheresis after the last dose of immunotherapy to obtain specimens for immunologic tests
Patients are followed every 3 months for the first year and annually thereafter
PROJECTED ACCRUAL A total of 14-26 patients will be accrued for this study within 2 years
Evaluate the ability of active immunotherapy with carcinoembryonic antigen CEA RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant
Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population
OUTLINE Dendritic cells are taken from the leukapheresis product obtained during the peripheral blood stem cell transplant procedure performed prior to treatment on this study The dendritic cells are pulsed with carcinoembryonic antigen CEA RNA Approximately 60-90 days after the peripheral blood stem cell transplant patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses Patients undergo a second leukopheresis after the last dose of immunotherapy to obtain specimens for immunologic tests
Patients are followed every 3 months for the first year and annually thereafter
PROJECTED ACCRUAL A total of 14-26 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000066458 | OTHER | NCI | None |
| IRB 2030 | OTHER | None | None |