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Vaccine Therapy in Treating Patients With Ductal Carcinoma In Situ of the Breast

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00923143
First received: June 17, 2009
Last updated: July 9, 2009
Last verified: June 2009
History of Changes
  Purpose

RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may help the body build an effective immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best way to give vaccine therapy and to see how well it works in treating patients with ductal carcinoma in situ of the breast.


Condition Intervention Phase
Breast Cancer
 Biological: HER-2/neu peptide vaccine
Biological: therapeutic autologous dendritic cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety as assessed by NCI CTC v3.0 [ Designated as safety issue: Yes ]
  • Immune response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in HER2/neu molecular expression pre-and post-vaccination [ Designated as safety issue: No ]
  • Clinical response [ Designated as safety issue: No ]
  • Possible relationship between immune and clinical response and changes in HER2/neu molecular expression [ Designated as safety issue: No ]

Estimated Enrollment: 57
Study Start Date: March 2009
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally into 1-2 different normal groin or axillary lymph nodes once weekly for 6 weeks.
 Biological: HER-2/neu peptide vaccine
Given intranodally and/or intralesionally
Biological: therapeutic autologous dendritic cells
Given intranodally and/or intralesionally
Experimental: Arm II
Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intralesionally into the quadrant of the affected breast once weekly for 6 weeks.
 Biological: HER-2/neu peptide vaccine
Given intranodally and/or intralesionally
Biological: therapeutic autologous dendritic cells
Given intranodally and/or intralesionally
Experimental: Arm III
Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally and intralesionally as in arms I and II.
 Biological: HER-2/neu peptide vaccine
Given intranodally and/or intralesionally
Biological: therapeutic autologous dendritic cells
Given intranodally and/or intralesionally

Detailed Description:

OBJECTIVES:

Primary

  • To establish the safety of HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine when administered via 3 different routes in patients with ductal carcinoma in situ of the breast.
  • To establish the immune response rate in patients treated with this vaccine.

Secondary

  • To evaluate changes in HER2/neu molecular expression pre- and post-vaccination.
  • To evaluate the clinical response pre-and post-vaccination.
  • To conduct exploratory analyses of possible relationships among these outcomes.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

Patients undergo leukapheresis to obtain monocyte fractions for generation of the vaccine. The monocytes are cultured with GM-CSF, interleukin-4, interferon gamma, and lipopolysaccharide and pulsed with HER2/neu peptides for the production of type 1 dendritic cells.

  • Arm I: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally into 1-2 different normal groin or axillary lymph nodes once weekly for 6 weeks.
  • Arm II: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intralesionally into the quadrant of the affected breast once weekly for 6 weeks.
  • Arm III: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally and intralesionally as in arms I and II.

Within 2-3 weeks after the completion of the last vaccination, patients undergo complete surgical excision (wide excision or mastectomy to negative margins) of their tumor.

After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS)

    • DCIS with evidence of microinvasion allowed
  • HER2/neu-positive tumor, as defined by > 5% of tumor cells staining ≥ 2+ by Hercept (Dako) antibody testing
  • No evidence of invasive breast cancer by MRI performed within the past 2 months

  • Hormone-receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Ejection fraction ≥ 50% by MUGA
  • No major cardiac illness

  • No coagulopathies, including any of the following:

    • Thrombocytopenia with platelet count < 75,000/mm^3
    • INR > 1.5
    • PTT > 50 sec
  • No laboratory tests (including CBC, liver function tests, urinalysis, and EKG) reflecting > grade 1 toxicity, as assessed by NCI CTC v3.0, that cannot be corrected on repeat testing within 7 days
  • No HIV or hepatitis C positivity
  • No other pre-existing medical illness that may interfere with study participation

PRIOR CONCURRENT THERAPY:

  • No prior definitive treatment for DCIS
  • No prior complete excisional biopsy of the tumor
  • No concurrent medications that may interfere with study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923143

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers     800-474-9892        
Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brian J. Czerniecki, MD, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Brian J. Czerniecki, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00923143     History of Changes
Other Study ID Numbers: CDR0000644921, UPCC-15107, 807010
Study First Received: June 17, 2009
Last Updated: July 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
HER2-positive breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on June 17, 2013