Clincosm LogoSign in Get a demo

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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00107211
Collaborator
National Cancer Institute (NCI) (NIH)
30
Enrollment
1
Location
42
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: therapeutic autologous dendritic cells
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Primary Purpose:
Treatment
Official Title:
A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283

    Sponsors and Collaborators

    • Abramson Cancer Center of the University of Pennsylvania
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Brian J. Czerniecki, MD, PhD, Abramson Cancer Center of the University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00107211
    Other Study ID Numbers:
    • CDR0000416200
    • UPCC-08102
    • UPCC-704447
    First Posted:
    Apr 6, 2005
    Last Update Posted:
    Sep 17, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by , ,
    ductal breast carcinoma in situ
    breast cancer in situ
    Additional relevant MeSH terms:
    Carcinoma in Situ

    Study Results

    No Results Posted as of Sep 17, 2014