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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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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 PennsylvaniaPhiladelphia, Pennsylvania  19104-4283