Clinical Trials /

HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer

NCT02063724

Description:

The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
  • Official Title: Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: MCC-18777
  • SECONDARY ID: 25113
  • NCT ID: NCT02063724
  • NCT ALIAS: NCT02110173

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
HER-2 pulsed Dendritic Cell VaccineHER-2 Pulsed Dendritic Cell Vaccine

Purpose

The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.

Detailed Description

      Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses
      giving breast cancer specific immune cells greater opportunity to function while the immune
      repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the
      chance to test secondary prevention of breast cancer in high risk settings. Participants with
      HER-2 driven IBC at least Stage IIIA with N2 (4 positive nodes) following chemotherapy with
      or without trastuzumab or those with recurrence exclusive of new primary tumor but rendered
      NED will be undergo mammograms, laboratory studies, and leukapheresis. Vaccines will be
      manufactured using participants' leukapheresis product, which will be administered in the
      Clinical Research Center 1 Dulles Building weekly for 6 weeks. Three booster vaccines will be
      administered at 3 month intervals following the initial induction vaccines. Immune analysis
      will be done after participant receives all induction vaccines and again after they receive
      all booster vaccines.

      This study began at the Abramson Cancer Center of the University of Pennsylvania and will be
      continued at H. Lee Moffitt Cancer Center and Research Institute.
    

Trial Arms

NameTypeDescriptionInterventions
HER-2 Pulsed Dendritic Cell VaccineExperimental6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Women over Age 18 years.
    
              -  Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than
                 or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered
                 NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+
                 FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1
                 year from their last treatment and have no evidence of disease.
    
              -  Deemed to require anti-estrogen therapy for treatment of their breast cancer can
                 continue anti-estrogen therapy during vaccinations.
    
              -  Women of childbearing age with a negative pregnancy test documented prior to
                 enrollment.
    
              -  Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
    
              -  Willing to use birth control if necessary.
    
              -  Have voluntarily signed a written Informed Consent in accordance with institutional
                 policies after its contents have been fully explained to them.
    
            Exclusion Criteria:
    
              -  Pregnant or lactating.
    
              -  Positive for positive HIV or hepatitis C at baseline.
    
              -  Patients with coagulopathies, including thrombocytopenia with platelet count less than
                 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
    
              -  Major cardiac illness MUGA less than 50% EF.
    
              -  Pre-existing medical illnesses or medications which might interfere with the study as
                 determined by Principal Investigator (PI).
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Change in Blood Pressure
    Time Frame:15, 30, 45, & 60 minutes post vaccine
    Safety Issue:
    Description:Blood pressure will be obtained just prior to the vaccination then every 15 minutes for the first hour after the dose is given in order to identify and measure any change from baseline.

    Secondary Outcome Measures

    Measure:Immune Response
    Time Frame:6-8 weeks, 1 year
    Safety Issue:
    Description:Participants will undergo leukapheresis after completion of 6 vaccines and 3 boost vaccines for the purpose of obtaining lymphocytes and monocytes for in vitro immunologic testing.
    Measure:Mammogram
    Time Frame:6-8 weeks
    Safety Issue:
    Description:All participants will have a post-vaccine bilateral mammogram to evaluate response to vaccination. Mammograms will be performed within two weeks after the 6th vaccination.

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

    Trial Keywords

    • Invasive Breast Cancer
    • Breast Cancer
    • Immunotherapy
    • Vaccine
    • Dendritic Cell

    Last Updated

    December 13, 2017