Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088985
Status:
TERMINATED
Last Update Posted:
2017-06-20
First Post:
2004-08-04
Brief Title:
Vaccine Therapy Trastuzumab and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial Evaluating The Efficacy Of A Multiepitope Dendritic Cell Vaccine Given With Trastuzumab And Vinorelbine For The Treatment Of Women With Metastatic Breast Cancer That Express HLA-A0201
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines may make the body build an immune response to kill tumor cells Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as vinorelbine work in different ways to stop tumor cells from dividing so they stop growing or die Combining vaccine therapy with monoclonal antibody therapy and chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving vaccine therapy together with trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic breast cancer
PURPOSE This phase II trial is studying how well giving vaccine therapy together with trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of multiepitope autologous dendritic cell vaccine trastuzumab Herceptin and vinorelbine by measuring the change in the largest dimension of metastatic lesions in women with locally recurrent or metastatic breast cancer that does not overexpress human epidermal growth factor receptor 2 HER2neu
Secondary
Determine the ability of this regimen to induce functional antigen-specific T cells in these patients by measuring ex-vivo antigen-specific T-cell activity against peptide-pulsed dendritic cells and tumor targets by tetramer staining and intracellular cytokine assays
OUTLINE
Autologous dendritic cell mobilization and harvest All patients undergo autologous dendritic cell mobilization with filgrastim G-CSF andor sargramostim GM-CSF subcutaneously daily for 4 days followed by apheresis Mobilized peripheral blood is processed for the production of dendritic cells by cluster of differentiation CD34-positive cell selection The dendritic cells are expanded and then pulsed with E75 and E90 peptides
Treatment Patients receive vinorelbine IV over 6-10 minutes and trastuzumab Herceptin IV over 90 minutes on day 1 Patients also receive autologous dendritic cells pulsed with E75 and E90 peptides subcutaneously over 2-5 minutes on day 1 Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Note If treatment is given locally the vaccine therapy will be given at University of North Carolina UNC -Chapel Hill the following day
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study
Primary
Determine the efficacy of multiepitope autologous dendritic cell vaccine trastuzumab Herceptin and vinorelbine by measuring the change in the largest dimension of metastatic lesions in women with locally recurrent or metastatic breast cancer that does not overexpress human epidermal growth factor receptor 2 HER2neu
Secondary
Determine the ability of this regimen to induce functional antigen-specific T cells in these patients by measuring ex-vivo antigen-specific T-cell activity against peptide-pulsed dendritic cells and tumor targets by tetramer staining and intracellular cytokine assays
OUTLINE
Autologous dendritic cell mobilization and harvest All patients undergo autologous dendritic cell mobilization with filgrastim G-CSF andor sargramostim GM-CSF subcutaneously daily for 4 days followed by apheresis Mobilized peripheral blood is processed for the production of dendritic cells by cluster of differentiation CD34-positive cell selection The dendritic cells are expanded and then pulsed with E75 and E90 peptides
Treatment Patients receive vinorelbine IV over 6-10 minutes and trastuzumab Herceptin IV over 90 minutes on day 1 Patients also receive autologous dendritic cells pulsed with E75 and E90 peptides subcutaneously over 2-5 minutes on day 1 Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Note If treatment is given locally the vaccine therapy will be given at University of North Carolina UNC -Chapel Hill the following day
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 17-37 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 |
|---|---|---|---|
| P50CA058223 | NIH | None | None |
| R21CA105837 | NIH | None | None |
| KG100307 | OTHER_GRANT | Susan G Komen for the Cure | httpsreporternihgovquickSearchR21CA105837 |