vaccine therapy in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast

Conditions: Breast Cancer

Summary: 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.

Eligibility 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

Keywords: ductal breast carcinoma in situ breast cancer in situ