<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/NCT01660529</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 03111</org_study_id>
    <nct_id>NCT01660529</nct_id>
  </id_info>
  <brief_title>Multi-peptide Vaccine With Basilixumab for Breast Cancer</brief_title>
  <official_title>A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV&#xD;
      multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab&#xD;
      20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the&#xD;
      time of Vaccines 1,3, and 5. Patients who remain clinically stable after the fourth vaccine,&#xD;
      may continue to receive vaccinations every 4 weeks for up to 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      hTERT is widely found in breast cancer cells and has a role in tumor growth and development,&#xD;
      making it attractive for immunotherapy. Also, recent data suggest that breast cancer is&#xD;
      potentially responsive to immunological therapies. In one trial, patients with advanced&#xD;
      cancer received a series of hTERT vaccinations and 4 of 7 patients with advanced breast or&#xD;
      prostate carcinoma developed hTERT-specific T lymphocytes. Partial tumor regression was&#xD;
      observed in 1 patient. In a second trial, 19 HLA A2+ patients with metastatic breast cancer&#xD;
      were vaccinated with hTERT 1540 peptide in adjuvant with GM-CSF. 68% of patients exhibited&#xD;
      immunological responses with development of CD8+ hTERT-specific T-cells. Overall survival of&#xD;
      vaccine responders was signifiantly better than the overall survival on non-responders. In&#xD;
      order to expand the number of possible immune responses and to potentially bypass immune&#xD;
      tolerance, multiple peptides have been added to the vaccine. In addition, the monoclonal&#xD;
      antibody basiliximab is included to decrease the regulatory T cells which prevent the immune&#xD;
      system to work against the tumor, and GM-CSF and Prevnar are used to boost the immune system.&#xD;
      Subjects will receive a maximum of 28 vaccinations over a 24 months period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">November 20, 2015</completion_date>
  <primary_completion_date type="Actual">November 20, 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>1st dose of basiliximab to 30 days after the last vaccination</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>hTERT/Survivin Multi-Peptide Vaccination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single-arm Phase I study for patients with metastatic breast cancer who have failed at least one regimen for metastatic disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>hTERT</intervention_name>
    <arm_group_label>hTERT/Survivin Multi-Peptide Vaccination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage IV (AJCC) breast cancer patients who have failed at least one conventional&#xD;
             therapy for metastatic disease.&#xD;
&#xD;
          -  HLA-A2 blood positive&#xD;
&#xD;
          -  Evidence of measurable or evaluable disease by clinical, radiographic, or laboratory&#xD;
             assessment.&#xD;
&#xD;
          -  Age greater than 18 years old&#xD;
&#xD;
          -  Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1&#xD;
&#xD;
          -  Life expectancy greater than 6 months&#xD;
&#xD;
          -  Adequate hematologic function established within 14 days before treatment: WBC equal&#xD;
             to or greater than 3.0, Plt equal to or greater than 75,000, Hgb equal to or greater&#xD;
             than 10 g/dl&#xD;
&#xD;
          -  Adequate renal function established within 14 days before treatment defined as serum&#xD;
             creatinine less than 1.5 times upper limit of normal&#xD;
&#xD;
          -  Adequate hepatic function established within 14 days before treatment defined as:&#xD;
             Total bilirubin, less than 1.5 times upper limit of normal, and ALT and AST less than&#xD;
             2.5 times upper limit of normal&#xD;
&#xD;
          -  Contrast CT and/or MRI of the brain negative for central nervous system metastases&#xD;
             within 30 days of treatment&#xD;
&#xD;
          -  Women of child bearing potential must have a negative pregnancy test (blood or urine)&#xD;
             within 14 days before treatment and agree to use appropriate contraception from study&#xD;
             screen through the duration of the trial. Men must agree to use appropriate&#xD;
             contraception from study screen through the duration of the trial.&#xD;
&#xD;
          -  Signed and dated written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of brain metastases within the last four years&#xD;
&#xD;
          -  Positivity for HIV-1/HIV-2, Hepatitis B virus, and Hepatitis C virus active infection&#xD;
&#xD;
          -  The use of the following within 14 days before treatment: Chemotherapy, Radiation&#xD;
             therapy, Immunosuppressive drugs, Systemic glucocorticoids, Hematopoietic growth&#xD;
             factors, Experimental therapy&#xD;
&#xD;
          -  Use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before&#xD;
             treatment, with the exception of low dose anti-coagulants to maintain intravenous&#xD;
             catheter patency.&#xD;
&#xD;
          -  Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30&#xD;
             days before treatment. 6. Patients who have been on a hormonal agent for at least 30&#xD;
             days prior to treatment with progressive or stable disease are permitted to enroll,&#xD;
             but required to stay on this hormonal agent for the duration of the study.&#xD;
&#xD;
          -  Initiation of immunotherapy (such as trastuzumab-Herceptin) in the 30 days before&#xD;
             treatment. Patients who have been on trastuzumab for at least 30 days prior to&#xD;
             treatment with progressive or stable disease are permitted to enroll, but required to&#xD;
             stay on trastuzumab for the duration of the study.&#xD;
&#xD;
          -  History of bone marrow or stem cell transplantation (allogeneic or autologous)&#xD;
&#xD;
          -  Pregnant women or nursing mothers&#xD;
&#xD;
          -  History of alcohol abuse or illicit drug use within 12 months of study initiation&#xD;
&#xD;
          -  Clinically significant comorbid disease or other underlying condition, including major&#xD;
             autoimmune disorders that would contraindicate study therapy or confuse interpretation&#xD;
             of study results&#xD;
&#xD;
          -  Significant psychiatric disorder and any other reason in the Investigators opinion&#xD;
             that would jeopardize protocol compliance or compromise the patients ability to give&#xD;
             informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Fox, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abramson Cancer Center at Penn Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abramson Cancer Center, University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>June 21, 2019</last_update_submitted>
  <last_update_submitted_qc>June 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Subjects with metastatic breast cancer who have failed at least one standard</keyword>
  <keyword>of care regimen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01660529
org study id: UPCC 03111
nct id: NCT01660529
lead sponsor: 
has dmc: Yes
Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV
      multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab
      20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the
      time of Vaccines 1,3, and 5. Patients who remain clinically stable after the fourth vaccine,
      may continue to receive vaccinations every 4 weeks for up to 2 years.
hTERT is widely found in breast cancer cells and has a role in tumor growth and development,
      making it attractive for immunotherapy. Also, recent data suggest that breast cancer is
      potentially responsive to immunological therapies. In one trial, patients with advanced
      cancer received a series of hTERT vaccinations and 4 of 7 patients with advanced breast or
      prostate carcinoma developed hTERT-specific T lymphocytes. Partial tumor regression was
      observed in 1 patient. In a second trial, 19 HLA A2+ patients with metastatic breast cancer
      were vaccinated with hTERT 1540 peptide in adjuvant with GM-CSF. 68% of patients exhibited
      immunological responses with development of CD8+ hTERT-specific T-cells. Overall survival of
      vaccine responders was signifiantly better than the overall survival on non-responders. In
      order to expand the number of possible immune responses and to potentially bypass immune
      tolerance, multiple peptides have been added to the vaccine. In addition, the monoclonal
      antibody basiliximab is included to decrease the regulatory T cells which prevent the immune
      system to work against the tumor, and GM-CSF and Prevnar are used to boost the immune system.
      Subjects will receive a maximum of 28 vaccinations over a 24 months period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Adverse Events
time frame: 1st dose of basiliximab to 30 days after the last vaccination
arm group label: hTERT/Survivin Multi-Peptide Vaccination
arm group type: Experimental
description: single-arm Phase I study for patients with metastatic breast cancer who have failed at least one regimen for metastatic disease
intervention type: Biological
intervention name: hTERT
arm group label: hTERT/Survivin Multi-Peptide Vaccination
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin Fox, MD
role: Principal Investigator
affiliation: Abramson Cancer Center at Penn Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms