<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/NCT01720836</url>
  </required_header>
  <id_info>
    <org_study_id>11-094</org_study_id>
    <secondary_id>902168</secondary_id>
    <nct_id>NCT01720836</nct_id>
  </id_info>
  <brief_title>Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer</brief_title>
  <official_title>Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) OR HILTONOL™ Adjuvant Vaccine in Patients With Localized and Locally Advanced Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olivera Finn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly&#xD;
      booster vaccines up to and including 5 years post last vaccine for those patients who are&#xD;
      confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are&#xD;
      two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer&#xD;
      peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant&#xD;
      prostate cancer and the other in subjects with advanced colonic adenomas at risk for&#xD;
      developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is&#xD;
      used in both trials. There has been no toxicity observed and the vaccine is highly&#xD;
      immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will&#xD;
      be thoroughly characterized.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">September 2029</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Immunologic response</measure>
    <time_frame>2 years</time_frame>
    <description>Immunologic response will be measured by increases in anti MUC1 antibody titers post vaccination at different stages of disease: localized (Stage I, II) or locally advanced (Stage III) non-small cell lung cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-MUC1 immunity</measure>
    <time_frame>2 years</time_frame>
    <description>To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between baseline MUC1 immunity and vaccine</measure>
    <time_frame>2 years</time_frame>
    <description>To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunocompetence versus immunosuppression</measure>
    <time_frame>2 years</time_frame>
    <description>To characterize the change in the balance between immunocompetence (response of T cells to polyclonal stimulation) versus immunosuppression at different stages of disease {check for increased numbers of regulatory T cells (Treg) and Myeloid-Derived Suppressor Cells (MDSC)}</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MUC1 associated safety</measure>
    <time_frame>2 years</time_frame>
    <description>To monitor adverse events associated with the study agents</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Non-small Cell Lung Cancer (NSCLC)</condition>
  <arm_group>
    <arm_group_label>Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage IB/II/IIIA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage IIIA or IIIB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vaccine + PolyICLC</intervention_name>
    <description>The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.</description>
    <arm_group_label>Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor</arm_group_label>
    <arm_group_label>Stage IB/II/IIIA</arm_group_label>
    <arm_group_label>Stage IIIA or IIIB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have histologically or cytologically confirmed non-small cell lung&#xD;
             cancer (NSCLC) or neuroendocrine carcinoid tumor&#xD;
&#xD;
          -  All subjects must have one of the following stages: Stage IA(T1NO); IB (T2NO), II &amp;&#xD;
             IIIA (N2 negative); IIIA (N2+), IIIB (N3+)&#xD;
&#xD;
          -  Patients must have stable disease at the time of enrollment&#xD;
&#xD;
          -  Women and men at least 18 years of age&#xD;
&#xD;
          -  ECOG performance status 0-1(Appendix A)&#xD;
&#xD;
          -  Subjects must be within 4 to 24 weeks of standard of care treatment for their&#xD;
             particular stage of disease&#xD;
&#xD;
          -  Subjects must have acceptable organ and marrow function as defined below:&#xD;
&#xD;
               -  Leukocytes &gt; 3,000/µL&#xD;
&#xD;
               -  Absolute Neutrophils &gt; 1,500/µL&#xD;
&#xD;
               -  Hemoglobin &gt; 10 g/dL&#xD;
&#xD;
               -  Platelets &gt; 100,000/µL&#xD;
&#xD;
               -  Total Bilirubin within normal institutional limits&#xD;
&#xD;
               -  Creatinine within normal institutional limits OR&#xD;
&#xD;
               -  Creatinine clearance &gt; 60 mL/min/1.73 m2 for subjects with above normal AST and&#xD;
                  ALT with alkaline phosphatase within &lt; 1.5 times upper limit of normal&#xD;
&#xD;
          -  The effects of a MUC1vaccine on the developing human fetus at the recommended&#xD;
             therapeutic dose are unknown. For this reason, men and women of childbearing potential&#xD;
             must be willing to use effective contraception (hormonal barrier method of birth&#xD;
             control; abstinence) while on study treatment and for at least 3 months thereafter.&#xD;
             Should a woman become pregnant or suspect she is pregnant while participating in this&#xD;
             study, she should inform her treating physician immediately&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects may not be receiving any other investigational agents&#xD;
&#xD;
             - No history of prior malignancy, except for non-melanoma skin cancer&#xD;
&#xD;
          -  Any positive ANA titer above 1:160, even in an asymptomatic individual. Note:&#xD;
&#xD;
        Weakly positive ANA defined as ANA titers up to 1:160 maximum (≤ 1:160) will be acceptable&#xD;
        in an asymptomatic individual who is otherwise eligible for the study.&#xD;
&#xD;
          -  Known Hepatitis B on immunomodulators (i.e. interferon)&#xD;
&#xD;
          -  Known Hepatitis C on immunomodulators (i.e. interferon)&#xD;
&#xD;
          -  No prior vaccine therapy&#xD;
&#xD;
          -  Patients may not be receiving any steroids or other anti-immune therapy at the time of&#xD;
             registration.&#xD;
&#xD;
          -  Subjects must not be more than 24 weeks from standard of care treatment for their&#xD;
             particular stage of disease&#xD;
&#xD;
          -  Subjects must not have post-obstructive pneumonia or other serious infection at the&#xD;
             time of registration or other serious underlying medical condition that would impair&#xD;
             the ability of the subjects to receive protocol treatment&#xD;
&#xD;
          -  Prior resection of lung cancer is allowed, if at least five years have elapsed between&#xD;
             previous resection and registration&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Pregnant women are excluded from this study. Women of childbearing potential must have&#xD;
             a negative pregnancy test&#xD;
&#xD;
          -  Subjects with immune deficiency are not expected to respond to the vaccine. Therefore,&#xD;
             known HIV-positive patients are excluded from the study&#xD;
&#xD;
          -  Subjects with a history of known autoimmune disease are excluded from this study&#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>Arjun Pennathur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julie Ward, RN, BSN</last_name>
    <phone>412-647-8583</phone>
    <email>wardj@upmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Judy Forster, RN, BSN, BS</last_name>
    <phone>412-647-8579</phone>
    <email>forsterje@upmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Olivera Finn</investigator_full_name>
    <investigator_title>Professor of Immunology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poly ICLC</mesh_term>
  </intervention_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/NCT01720836
org study id: 11-094
secondary id: 902168
nct id: NCT01720836
lead sponsor: 
has dmc: Yes
All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly
      booster vaccines up to and including 5 years post last vaccine for those patients who are
      confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are
      two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer
      peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant
      prostate cancer and the other in subjects with advanced colonic adenomas at risk for
      developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is
      used in both trials. There has been no toxicity observed and the vaccine is highly
      immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will
      be thoroughly characterized.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Immunologic response
time frame: 2 years
description: Immunologic response will be measured by increases in anti MUC1 antibody titers post vaccination at different stages of disease: localized (Stage I, II) or locally advanced (Stage III) non-small cell lung cancer.
measure: Anti-MUC1 immunity
time frame: 2 years
description: To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine
measure: Association between baseline MUC1 immunity and vaccine
time frame: 2 years
description: To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies
measure: Immunocompetence versus immunosuppression
time frame: 2 years
description: To characterize the change in the balance between immunocompetence (response of T cells to polyclonal stimulation) versus immunosuppression at different stages of disease {check for increased numbers of regulatory T cells (Treg) and Myeloid-Derived Suppressor Cells (MDSC)}
measure: MUC1 associated safety
time frame: 2 years
description: To monitor adverse events associated with the study agents
arm group label: Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor
arm group type: Experimental
description: Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
arm group label: Stage IB/II/IIIA
arm group type: Experimental
description: Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
arm group label: Stage IIIA or IIIB
arm group type: Experimental
description: Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.
intervention type: Biological
intervention name: Vaccine + PolyICLC
description: The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.
arm group label: Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor
arm group label: Stage IB/II/IIIA
arm group label: Stage IIIA or IIIB
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arjun Pennathur, MD
role: Principal Investigator
affiliation: University of Pittsburgh Medical Center
last name: Julie Ward, RN, BSN
phone: 412-647-8583
email: wardj@upmc.edu
last name: Judy Forster, RN, BSN, BS
phone: 412-647-8579
email: forsterje@upmc.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Olivera Finn
investigator title: Professor of Immunology
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Poly ICLC