Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR DCIS with microinvasion (< 1 mm) by core biopsy or excisional biopsy - HER2/neu positive tumor, defined as > 10% of the tumor population expressing HER2/neu by immunohistochemical staining - No evidence of invasive disease by MRI (performed within the past month) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Over 18 Sex - Not specified Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - No thrombocytopenia (i.e., platelet count < 75,000/mm^3) - No other coagulopathy Hepatic - No hepatitis C positivity - INR > 1.5 - PTT > 50 sec Renal - Not specified Cardiovascular - Ejection fraction ≥ 50% by MUGA or echocardiogram - No major cardiac illness Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No HIV positivity - No toxicity > grade 1 - No other pre-existing medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior ipsilateral breast or axillary radiotherapy Surgery - No prior ipsilateral axillary dissection - No prior complete excisional biopsy for DCIS Other - No other prior definitive treatment for DCIS - No concurrent medications that would preclude study participation


NCT ID:

NCT00107211


Primary Contact:

Principal Investigator
Brian J. Czerniecki, MD, PhD
Abramson Cancer Center of the University of Pennsylvania


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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