Phase II Trial Evaluating the Toxicity and Efficacy of a Multiepitope Dendritic Cell Vaccine Given With Trastuzumab and Vinorelbine Ditartrate for the Treatment of Women With Metastatic Breast Cancer That Express HLA-A0201 and Whose Tumors Overexpress HER-2/NEU
- Determine the efficacy of multiepitope autologous dendritic cell vaccine in combination
with trastuzumab (Herceptin®) and vinorelbine ditartrate in patients with locally
recurrent or metastatic breast cancer whose tumors overexpress HER2/neu.
- Determine if this regimen is effective in generating functional antigen-specific T
- Therapeutic autologous dendritic cell (DC) preparation: Patients undergo mobilization
of DC and apheresis for production of therapeutic DC. DCs are expanded in vitro for
10-20 days and pulsed with E75 and E90 peptides.
- Treatment: Patients receive vinorelbine ditartrate IV over 6-10 minutes, therapeutic
autologous DC intradermally over 2-5 minutes, and trastuzumab (Herceptin®) IV over
30-90 minutes on day 1. Patients receive sargramostim (GM-CSF) subcutaneously on days
2, 4, and 6, or until neutrophil counts recover. Treatment repeats every 14 days for up
to 6 courses (or more at the discretion of the investigator) in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jonathan S. Serody, MD
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|