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