Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast
Recruitment status was Active, not recruiting
RATIONALE: Vaccines made from peptides and a person's white blood cells may help the body build an effective immune response to kill tumor cells. Injecting the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. Giving vaccine therapy before surgery may be effective treatment for ductal carcinoma in situ of the breast.
PURPOSE: This phase I trial is studying the side effects and best way to give vaccine therapy in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast.
Biological: therapeutic autologous dendritic cells
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS|
|Study Start Date:||January 2005|
|Estimated Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107211
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Principal Investigator:||Brian J. Czerniecki, MD, PhD||Abramson Cancer Center of the University of Pennsylvania|