A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
- Determine the feasibility and safety of neoadjuvant ultrasound-guided intranodal
vaccine therapy comprising autologous dendritic cells pulsed with recombinant HER2/neu
peptides in patients with ductal carcinoma in situ of the breast.
- Determine the sensitization of CD4+ and CD8+ T cells to HER2/neu in patients treated
with this vaccine.
- Determine clinical response in patients treated with this vaccine.
- Correlate post-vaccine sensitization of CD4+ and CD8+ T cells to HER2/neu with clinical
response in patients treated with this vaccine.
OUTLINE: This is a pilot study.
Patients undergo leukapheresis over 2-3 hours to obtain lymphocytes and monocytes. Monocytes
are cultured with sargramostim (GM-CSF), interleukin-4, interferon gamma, and
lipopolysaccharides for the production of dendritic cells (DC). DC are then pulsed with
recombinant HER2/neu peptides to produce the dendritic cell vaccine. Approximately 2 days
after leukapheresis, patients receive the vaccine intranodally (into 2 different lymph
nodes) by ultrasound guidance once a week for 4 weeks in the absence of unacceptable
toxicity. Patients then undergo a second leukapheresis to obtain T lymphocytes for
immunologic analysis. Within 2-3 weeks after completion of vaccine therapy, patients undergo
lumpectomy or mastectomy AND sentinel lymph node biopsy.
After completion of study treatment, patients are followed every 6 months for 5 years and
then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Primary Purpose: Treatment
Brian J. Czerniecki, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|