Finding studies
Finding studies
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Lead
Abramson Cancer Center at Penn Medicine
With
OBJECTIVES: Primary * 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. Secondary * 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
