Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast
Status and phase
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About
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.
Full description
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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR DCIS with microinvasion (< 1 mm) by core biopsy or excisional biopsy
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HER2/neu positive tumor, defined as > 10% of the tumor population expressing HER2/neu by immunohistochemical staining
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No evidence of invasive disease by MRI (performed within the past month)
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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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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