A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
18 Years
N/A
Both
Breast Cancer
Trial Information
A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Brian J. Czerniecki, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Federal Government
Study ID:
CDR0000416200
NCT ID:
NCT00107211
Start Date:
January 2005
Completion Date:
Related Keywords:
- Breast Cancer
- ductal breast carcinoma in situ
- breast cancer in situ
- Breast Neoplasms
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
