<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014076</url>
  </required_header>
  <id_info>
    <org_study_id>C.2008.146</org_study_id>
    <nct_id>NCT03014076</nct_id>
  </id_info>
  <brief_title>Immunotherapy Vaccine and Herceptin in Breast Cancer</brief_title>
  <official_title>Phase Ib Trial of Combination Immunotherapy With HER2/Neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Insight, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Insight, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2&#xD;
      peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment&#xD;
      of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a&#xD;
      primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the&#xD;
      study are the following:&#xD;
&#xD;
        -  Assess safety and document local and systemic toxicity to combination immunotherapy with&#xD;
           GP2 peptide + GM-CSF vaccine and trastuzumab&#xD;
&#xD;
        -  Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of&#xD;
           GP2 peptide + GM-CSF vaccine and trastuzumab&#xD;
&#xD;
        -  Determine maximum tolerated dose and optimal biologic dose for the combination&#xD;
           immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-Related Adverse Events as Assessed by CTCAE v4.0</measure>
    <time_frame>12 months</time_frame>
    <description>Patients receiving treatment will be followed from baseline to completion of study for adverse events using CTCAE v4.0</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Breastcancer</condition>
  <arm_group>
    <arm_group_label>GP2 peptide + GM-CSF + trastuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HLA-A2+/A3+ subjects receive GP2 + GM-CSF vaccine and trastzumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trastuzumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>HLA-A2-/A3- subjects followed as controls receiving trastuzumab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GP2 peptide + GM-CSF vaccine plus trastuzumab</intervention_name>
    <description>HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab</description>
    <arm_group_label>GP2 peptide + GM-CSF + trastuzumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.</description>
    <arm_group_label>Trastuzumab</arm_group_label>
    <other_name>Herceptin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  HER2/neu+ over-expressing breast cancer (IHC 3+ or FISH ≥2.0)&#xD;
&#xD;
          -  Patients who are receiving adjuvant trastuzumab as standard of care treatment&#xD;
&#xD;
          -  Completion of breast cancer therapy (i.e., surgery, radiation, and chemotherapy as&#xD;
             appropriate per standard of care for patients' specific cancer) to exclude trastuzumab&#xD;
             (Patients on oral hormonal therapy as part of their adjuvant breast cancer treatment&#xD;
             will be maintained on their regimens.)&#xD;
&#xD;
          -  Enrollment must occur so that patients' trastuzumab treatment and vaccine schedule&#xD;
             overlap for all 6 vaccinations and so that first vaccination occurs after a standard&#xD;
             of care Multiple Gated Acquisition Scan (MUGA)&#xD;
&#xD;
          -  ECOG performance status (PS) 0-1&#xD;
&#xD;
          -  Clinically cancer-free (no evidence of disease; excluding +CTC)&#xD;
&#xD;
          -  If the patient is of childbearing potential, she must be willing to practice adequate&#xD;
             contraception through the study treatment period and for 2 months after completion of&#xD;
             the injection sites&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical and/or radiographic evidence of residual or persistent breast cancer&#xD;
&#xD;
          -  Receiving immunosuppressive therapy to include methotrexate or steroids (note: the use&#xD;
             of prednisone, or equivalent, &lt;2.0mg/day, is allowed)&#xD;
&#xD;
          -  Tbili &gt;1.8, creatinin &gt;2, hemoglobin &lt;10, platelets &lt;100,000/mm³, WBC &lt;2,000&#xD;
&#xD;
          -  Active pulmonary disease requiring medication to include multiple inhalers&#xD;
&#xD;
          -  Patients may not be receiving any other investigational agents (except with permission&#xD;
             of the Lead Principal Investigator)&#xD;
&#xD;
          -  Pregnant or are nursing&#xD;
&#xD;
          -  History of autoimmune disease (patients with vitiligo not excluded)&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Previous or concomitant malignancies at other sites, except effectively treated non-&#xD;
             melanoma skin cancers or carcinoma in situ of the cervix or effectively treated&#xD;
             malignancy that has been in remission for over 5 years and highly likely to have been&#xD;
             cured&#xD;
&#xD;
          -  Other concurrent severe medical problems, unrelated to the malignancy, that would&#xD;
             significantly limit full compliance with the study or expose the patient to&#xD;
             unacceptable risk&#xD;
&#xD;
          -  Uncontrolled congestive heart failure or hypertension, unstable heart disease&#xD;
             (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the&#xD;
             time of enrollment&#xD;
&#xD;
          -  Psychiatric, addictive, or any disorder which compromises ability to give truly&#xD;
             informed consent for participation in this study or adequate compliance&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George E Peoples, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Insight</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Insight, LLC</investigator_affiliation>
    <investigator_full_name>George E. Peoples</investigator_full_name>
    <investigator_title>CEO/Founder</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014076
org study id: C.2008.146
nct id: NCT03014076
lead sponsor: 
has dmc: Yes
The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2
      peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment
      of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a
      primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the
      study are the following:

        -  Assess safety and document local and systemic toxicity to combination immunotherapy with
           GP2 peptide + GM-CSF vaccine and trastuzumab

        -  Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of
           GP2 peptide + GM-CSF vaccine and trastuzumab

        -  Determine maximum tolerated dose and optimal biologic dose for the combination
           immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment-Related Adverse Events as Assessed by CTCAE v4.0
time frame: 12 months
description: Patients receiving treatment will be followed from baseline to completion of study for adverse events using CTCAE v4.0
arm group label: GP2 peptide + GM-CSF + trastuzumab
arm group type: Experimental
description: HLA-A2+/A3+ subjects receive GP2 + GM-CSF vaccine and trastzumab
arm group label: Trastuzumab
arm group type: Active Comparator
description: HLA-A2-/A3- subjects followed as controls receiving trastuzumab.
intervention type: Drug
intervention name: GP2 peptide + GM-CSF vaccine plus trastuzumab
description: HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab
arm group label: GP2 peptide + GM-CSF + trastuzumab
intervention type: Drug
intervention name: Trastuzumab
description: HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.
arm group label: Trastuzumab
other name: Herceptin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: George E Peoples, MD
role: Principal Investigator
affiliation: Cancer Insight
responsible party type: Principal Investigator
investigator affiliation: Cancer Insight, LLC
investigator full name: George E. Peoples
investigator title: CEO/Founder
mesh term: Breast Neoplasms
mesh term: Trastuzumab
sharing ipd: No