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
- 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 HER2/neu.
- 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
- Autologous dendritic cell mobilization and harvest: All patients undergo autologous
dendritic cell mobilization with filgrastim (G-CSF) and/or sargramostim (GM-CSF)
subcutaneously daily for 4 days followed by apheresis. Mobilized peripheral blood is
processed for the production of dendritic cells by 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
NOTE: *If treatment is given locally, the vaccine therapy will be given at 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response measured by RECIST criteria
6 months following treatment
Jonathan S. Serody, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|