Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: therapeutic autologous dendritic cells
* Procedure: conventional surgery
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: therapeutic autologous dendritic cells|nan|
|Procedure: conventional surgery|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ductal breast carcinoma in situ, breast cancer in situ