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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00107211
First received: April 5, 2005
Last updated: September 16, 2014
Last verified: September 2014

April 5, 2005
September 16, 2014
January 2005
July 2008   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00107211 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast
A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS

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.

Interventional
Phase 1
Primary Purpose: Treatment
Breast Cancer
  • Biological: therapeutic autologous dendritic cells
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107211
CDR0000416200, UPCC-08102, UPCC-704447
Yes
Not Provided
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Brian J. Czerniecki, MD, PhD Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP