A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
- To establish the safety of HER2/neu peptide-pulsed autologous type 1 dendritic cell
vaccine when administered via 3 different routes in patients with ductal carcinoma in
situ of the breast.
- To establish the immune response rate in patients treated with this vaccine.
- To evaluate changes in HER2/neu molecular expression pre- and post-vaccination.
- To evaluate the clinical response pre-and post-vaccination.
- To conduct exploratory analyses of possible relationships among these outcomes.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
Patients undergo leukapheresis to obtain monocyte fractions for generation of the vaccine.
The monocytes are cultured with GM-CSF, interleukin-4, interferon gamma, and
lipopolysaccharide and pulsed with HER2/neu peptides for the production of type 1 dendritic
- Arm I: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell
vaccine intranodally into 1-2 different normal groin or axillary lymph nodes once
weekly for 6 weeks.
- Arm II: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell
vaccine intralesionally into the quadrant of the affected breast once weekly for 6
- Arm III: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell
vaccine intranodally and intralesionally as in arms I and II.
Within 2-3 weeks after the completion of the last vaccination, patients undergo complete
surgical excision (wide excision or mastectomy to negative margins) of their tumor.
After completion of study treatment, patients are followed up every 6 months for 5 years and
then annually thereafter.
Allocation: Randomized, Primary Purpose: Treatment
Safety as assessed by NCI CTC v3.0
Brian J. Czerniecki, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|