<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/NCT03300817</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2017-01781</org_study_id>
    <secondary_id>NCI-2017-01781</secondary_id>
    <secondary_id>N01-CN-2012-00042</secondary_id>
    <secondary_id>MAY2016-08-01</secondary_id>
    <secondary_id>MAY2016-08-01</secondary_id>
    <secondary_id>N01CN00042</secondary_id>
    <secondary_id>P30CA015083</secondary_id>
    <nct_id>NCT03300817</nct_id>
  </id_info>
  <brief_title>MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer</brief_title>
  <official_title>A Pilot Study of MUC1 Vaccine in Current and Former Smokers at High Risk for Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot phase I trial studies the side effects and how well MUC1 peptide-Poly-ICLC vaccine&#xD;
      works in preventing lung cancer in current and former smokers at high risk for lung cancer.&#xD;
      Vaccines made from peptides may help the body build an effective immune response to kill&#xD;
      cells. MUC1 peptide-Poly-ICLC vaccine may stimulate the body's immune system and slow or stop&#xD;
      the changes from normal to pre-cancer to cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Immunogenicity of the vaccine, assessed at week 12, based on the increase in IgG anti-MUC1&#xD;
      antibody titer over the pre-vaccination levels.&#xD;
&#xD;
      II. Safety, assessed throughout the trial and continued observation for 24 weeks.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To explore potential differences, if any, in the immunogenicity of the vaccine (as&#xD;
      assessed at week 12 by the IgG anti-MUC1 antibody titer ratio) in current versus (vs.) former&#xD;
      smokers.&#xD;
&#xD;
      II. To evaluate pre-vaccination levels of circulating myeloid derived suppressor cells (MDSC)&#xD;
      and correlate with the ability to respond to the vaccine.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To explore immune response at week 24. II. To explore the relationship between chronic&#xD;
      obstructive pulmonary disease (COPD) status at pre-registration and immune response in&#xD;
      current versus former smokers.&#xD;
&#xD;
      III. To explore the impact of the MUC1 peptide-Poly-ICLC vaccine (MUC1/Poly-ICLC vaccine) on&#xD;
      inflammation-related high sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6)&#xD;
      levels.&#xD;
&#xD;
      IV. To explore the impact of baseline levels of hsCRP and IL-6 on the ability to successfully&#xD;
      vaccinate with MUC1/Poly-ICLC.&#xD;
&#xD;
      V. To establish a biospecimen repository archive: frozen peripheral blood live cells and&#xD;
      plasma for future more detailed and comprehensive immunologic assays, including direct&#xD;
      testing of anti-MUC1 T cell immunity.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive MUC1 peptide-Poly-ICLC vaccine subcutaneously (SC) at weeks 0, 2, and 10.&#xD;
&#xD;
      After completion of study treatment, patients may be followed up at week 28.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 27, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Actual">September 23, 2021</primary_completion_date>
  <phase>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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Immunogenicity of the MUC1 Vaccine</measure>
    <time_frame>At week 12</time_frame>
    <description>Will be evaluated by monitoring changes in IgG anti-MUC1 antibody titer ratio; defined as t12/t0, where t0 is the &quot;initial titer&quot; measured prior to vaccination, and t12 is the &quot;final titer&quot; drawn at 12 weeks. A titer ratio of &gt;= 2 will be considered a positive response.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment</measure>
    <time_frame>24 weeks</time_frame>
    <description>Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.0. The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. In addition, the number and severity of adverse events will be tabulated and summarized across all grades.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of Smoking Status on Vaccine Response</measure>
    <time_frame>12 weeks</time_frame>
    <description>To explore potential differences, if any, in the immunogenicity of the vaccine (as assessed at week 12 by the IgG anti-MUC1 antibody titer ratio) in current vs. former smokers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-Vaccination Levels Versus Post-Vaccination Levels of Circulating Myeloid Derived Suppressor Cells (MDSC)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Will correlate with the ability to respond to the vaccine. Will summarize the data using descriptive statistics and graphical methods (i.e. boxplots, scatter plots, etc.). For continuous MDSC data versus response data, will use t-tests or Wilcoxon Rank-Sum tests (for non-normal data).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Chronic Obstructive Pulmonary Disease (COPD) Status</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>Will explore the relationship between COPD status at pre-registration and immune response in current versus former smokers. In individuals with COPD, the severity of airflow obstruction will be measured by the pulmonary function tests as per the GOLD classification.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Immunogenicity in Individuals With Chronic Obstructive Pulmonary Disease (COPD)</measure>
    <time_frame>Baseline up to week 12</time_frame>
    <description>Will explore whether or not changes in immunogenicity in individuals with COPD corresponds to different circulating MDSC levels.</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of the MUC1/Poly-ICLC Vaccine on Inflammation-Related High Sensitivity C-Reactive Protein (hsCRP) and Interleukin-6 (IL-6)</measure>
    <time_frame>Up to week 24</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Ability to Successfully Vaccinate With MUC1/Poly-ICLC Vaccine Depending on Baseline High Sensitivity C-Reactive Protein (hsCRP) and Interleukin-6 (IL-6) Levels</measure>
    <time_frame>Up to week 24</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Lung Carcinoma</condition>
  <arm_group>
    <arm_group_label>Prevention (MUC1 peptide-Poly-ICLC vaccine)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Prevention (MUC1 peptide-Poly-ICLC vaccine)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MUC1 Peptide-Poly-ICLC Vaccine</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Prevention (MUC1 peptide-Poly-ICLC vaccine)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PRE-REGISTRATION INCLUSION CRITERIA&#xD;
&#xD;
          -  Smoking history of &gt;= 30 pack-years AND either current smoker (still smoking or quit &lt;&#xD;
             1 year prior to pre-registration) OR former smoker (quit 1-15 years prior to&#xD;
             pre-registration); Note: Pack years is determined by multiplying the number of packs&#xD;
             smoked per day by the number of years smoked&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 1&#xD;
&#xD;
          -  Computed tomography (CT) scan of the chest done =&lt; 6 months prior to pre-registration&#xD;
             showing either negative findings (no nodules) or solid or part-solid nodules &lt; 6 mm in&#xD;
             size (consistent with &lt; 1% probability of malignancy, Lung-Reporting and Data Systems&#xD;
             [RADs] version 1.0)&#xD;
&#xD;
          -  Willingness to employ adequate contraception, if applicable; Note: women of&#xD;
             child-bearing potential and men must agree to use adequate contraception (hormonal or&#xD;
             barrier method of birth control; abstinence) prior to study entry and for the duration&#xD;
             of study participation; should a woman become pregnant or suspect she is pregnant&#xD;
             while participating in this study, she should inform her study physician immediately&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
          -  REGISTRATION INCLUSION CRITERIA&#xD;
&#xD;
          -  Leukocytes (white blood cell [WBC]) &gt;= 3,000/microliter&#xD;
&#xD;
          -  Neutrophils (absolute neutrophil count [ANC]) &gt;= 1,500/microliter&#xD;
&#xD;
          -  Platelets &gt;= 100,000/microliter&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x institutional upper limit of normal (ULN) Note: Higher total&#xD;
             bilirubin levels (=&lt; 3 mg/dL) can be allowed if due to known benign liver condition,&#xD;
             i.e. Gilbert's&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =&lt;&#xD;
             1.5 x institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =&lt; 1.5 x&#xD;
             institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  Creatinine =&lt; institutional upper limit of normal (ULN)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PRE-REGISTRATION EXCLUSION CRITERIA&#xD;
&#xD;
          -  History of any malignancy; exceptions: non-melanoma skin cancer or carcinoma in situ&#xD;
             (CIS) of the cervix&#xD;
&#xD;
          -  Known hepatitis B or C&#xD;
&#xD;
          -  Receiving any other investigational agents&#xD;
&#xD;
          -  Any prior investigational immune therapy, such as for lung cancer prevention or&#xD;
             treatment or for CIS of the cervix&#xD;
&#xD;
          -  Use of oral or systemic steroids or other systemic anti-immune therapy =&lt; 90 days&#xD;
             prior to pre-registration; Note: Use of inhaled/nasal steroids and local steroid&#xD;
             injections for pain control are not exclusionary&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Known autoimmune disease&#xD;
&#xD;
          -  Known non-alcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease&#xD;
             (NAFLD)&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to MUC1/Poly-ICLC&#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;
          -  REGISTRATION EXCLUSION CRITERIA&#xD;
&#xD;
          -  Any positive antinuclear antibody (ANA) titer above 1:160, even in an asymptomatic&#xD;
             individual. Note: Weakly positive ANA defined as ANA titers up to 1:160 maximum (=&lt;&#xD;
             1:160) will be acceptable in an asymptomatic individual who is otherwise eligible for&#xD;
             the study&#xD;
&#xD;
          -  Pregnant or breast feeding; Note: Pregnant women are excluded from this study because&#xD;
             the MUC1/Poly-ICLC vaccine may have the potential for teratogenic or abortifacient&#xD;
             effects. Because there is an unknown but potential risk for adverse events (AEs) in&#xD;
             nursing infants secondary to treatment of the mother with MUC1/Poly-ICLC vaccine,&#xD;
             breastfeeding should be discontinued if the mother is treated with the vaccine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arjun Pennathur</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic in Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute (UPCI)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>November 25, 2022</results_first_submitted>
  <results_first_submitted_qc>March 27, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2023</results_first_posted>
  <last_update_submitted>April 29, 2023</last_update_submitted>
  <last_update_submitted_qc>April 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03300817/Prot_SAP_ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>1 patient withdrew prior to beginning treatment and has been removed from all analyses</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Prevention (MUC1 Peptide-Poly-ICLC Vaccine)</title>
          <description>Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
MUC1 Peptide-Poly-ICLC Vaccine: Given SC</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Found to be Ineligible</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prevention (MUC1 Peptide-Poly-ICLC Vaccine)</title>
          <description>Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
MUC1 Peptide-Poly-ICLC Vaccine: Given SC</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.4" spread="4.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Current Smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former Smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83.1" spread="19.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Immunogenicity of the MUC1 Vaccine</title>
        <description>Will be evaluated by monitoring changes in IgG anti-MUC1 antibody titer ratio; defined as t12/t0, where t0 is the &quot;initial titer&quot; measured prior to vaccination, and t12 is the &quot;final titer&quot; drawn at 12 weeks. A titer ratio of &gt;= 2 will be considered a positive response.</description>
        <time_frame>At week 12</time_frame>
        <population>4 patients are excluded from this analysis because they did not receive injections at weeks 2 and 10</population>
        <group_list>
          <group group_id="O1">
            <title>Prevention (MUC1 Peptide-Poly-ICLC Vaccine)</title>
            <description>Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
MUC1 Peptide-Poly-ICLC Vaccine: Given SC</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Immunogenicity of the MUC1 Vaccine</title>
          <description>Will be evaluated by monitoring changes in IgG anti-MUC1 antibody titer ratio; defined as t12/t0, where t0 is the &quot;initial titer&quot; measured prior to vaccination, and t12 is the &quot;final titer&quot; drawn at 12 weeks. A titer ratio of &gt;= 2 will be considered a positive response.</description>
          <population>4 patients are excluded from this analysis because they did not receive injections at weeks 2 and 10</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" lower_limit="5.1" upper_limit="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment</title>
        <description>Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.0. The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. In addition, the number and severity of adverse events will be tabulated and summarized across all grades.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (MUC1 Peptide-Poly-ICLC Vaccine)</title>
            <description>Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
MUC1 Peptide-Poly-ICLC Vaccine: Given SC</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment</title>
          <description>Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.0. The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. In addition, the number and severity of adverse events will be tabulated and summarized across all grades.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Smoking Status on Vaccine Response</title>
        <description>To explore potential differences, if any, in the immunogenicity of the vaccine (as assessed at week 12 by the IgG anti-MUC1 antibody titer ratio) in current vs. former smokers.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Current Smoker</title>
            <description>Patients that currently smoke</description>
          </group>
          <group group_id="O2">
            <title>Former Smoker</title>
            <description>Patients that no longer smoke, but did in the past</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Smoking Status on Vaccine Response</title>
          <description>To explore potential differences, if any, in the immunogenicity of the vaccine (as assessed at week 12 by the IgG anti-MUC1 antibody titer ratio) in current vs. former smokers.</description>
          <units>participants that responded to vaccine</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pre-Vaccination Levels Versus Post-Vaccination Levels of Circulating Myeloid Derived Suppressor Cells (MDSC)</title>
        <description>Will correlate with the ability to respond to the vaccine. Will summarize the data using descriptive statistics and graphical methods (i.e. boxplots, scatter plots, etc.). For continuous MDSC data versus response data, will use t-tests or Wilcoxon Rank-Sum tests (for non-normal data).</description>
        <time_frame>12 weeks</time_frame>
        <population>Only patients with available data on levels of circulating myeloid derived suppressor cells at 12 weeks are included</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Responder</title>
            <description>Patients that did not experience a MUC1-specific IgG antibody titer that is ≥2 fold higher at 12 weeks compared to baseline</description>
          </group>
          <group group_id="O2">
            <title>Responder</title>
            <description>Patients that experienced a MUC1-specific IgG antibody titer that is ≥2 fold higher at 12 weeks compared to baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-Vaccination Levels Versus Post-Vaccination Levels of Circulating Myeloid Derived Suppressor Cells (MDSC)</title>
          <description>Will correlate with the ability to respond to the vaccine. Will summarize the data using descriptive statistics and graphical methods (i.e. boxplots, scatter plots, etc.). For continuous MDSC data versus response data, will use t-tests or Wilcoxon Rank-Sum tests (for non-normal data).</description>
          <population>Only patients with available data on levels of circulating myeloid derived suppressor cells at 12 weeks are included</population>
          <units>percent CD33</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9" lower_limit="1.4" upper_limit="37.9"/>
                    <measurement group_id="O2" value="9.4" lower_limit="5.7" upper_limit="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6834</p_value>
            <method>Wilcoxon Rank-Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Chronic Obstructive Pulmonary Disease (COPD) Status</title>
        <description>Will explore the relationship between COPD status at pre-registration and immune response in current versus former smokers. In individuals with COPD, the severity of airflow obstruction will be measured by the pulmonary function tests as per the GOLD classification.</description>
        <time_frame>Baseline to week 12</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in Immunogenicity in Individuals With Chronic Obstructive Pulmonary Disease (COPD)</title>
        <description>Will explore whether or not changes in immunogenicity in individuals with COPD corresponds to different circulating MDSC levels.</description>
        <time_frame>Baseline up to week 12</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Impact of the MUC1/Poly-ICLC Vaccine on Inflammation-Related High Sensitivity C-Reactive Protein (hsCRP) and Interleukin-6 (IL-6)</title>
        <time_frame>Up to week 24</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ability to Successfully Vaccinate With MUC1/Poly-ICLC Vaccine Depending on Baseline High Sensitivity C-Reactive Protein (hsCRP) and Interleukin-6 (IL-6) Levels</title>
        <time_frame>Up to week 24</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prevention (MUC1 Peptide-Poly-ICLC Vaccine)</title>
          <description>Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
MUC1 Peptide-Poly-ICLC Vaccine: Given SC</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (12.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (12.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Edema face</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Immune system disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Serum amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Forced expiratory volume decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle weakness upper limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient ischemic attacks</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and medical procedures - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Paul J. Limburg, M.D., M.P.H.</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-2511</phone>
      <email>limburg.paul@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03300817
org study id: NCI-2017-01781
secondary id: NCI-2017-01781
secondary id: N01-CN-2012-00042
secondary id: MAY2016-08-01
secondary id: MAY2016-08-01
secondary id: N01CN00042
secondary id: P30CA015083
nct id: NCT03300817
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This pilot phase I trial studies the side effects and how well MUC1 peptide-Poly-ICLC vaccine
      works in preventing lung cancer in current and former smokers at high risk for lung cancer.
      Vaccines made from peptides may help the body build an effective immune response to kill
      cells. MUC1 peptide-Poly-ICLC vaccine may stimulate the body's immune system and slow or stop
      the changes from normal to pre-cancer to cancer.
PRIMARY OBJECTIVES:

      I. Immunogenicity of the vaccine, assessed at week 12, based on the increase in IgG anti-MUC1
      antibody titer over the pre-vaccination levels.

      II. Safety, assessed throughout the trial and continued observation for 24 weeks.

      SECONDARY OBJECTIVES:

      I. To explore potential differences, if any, in the immunogenicity of the vaccine (as
      assessed at week 12 by the IgG anti-MUC1 antibody titer ratio) in current versus (vs.) former
      smokers.

      II. To evaluate pre-vaccination levels of circulating myeloid derived suppressor cells (MDSC)
      and correlate with the ability to respond to the vaccine.

      EXPLORATORY OBJECTIVES:

      I. To explore immune response at week 24. II. To explore the relationship between chronic
      obstructive pulmonary disease (COPD) status at pre-registration and immune response in
      current versus former smokers.

      III. To explore the impact of the MUC1 peptide-Poly-ICLC vaccine (MUC1/Poly-ICLC vaccine) on
      inflammation-related high sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6)
      levels.

      IV. To explore the impact of baseline levels of hsCRP and IL-6 on the ability to successfully
      vaccinate with MUC1/Poly-ICLC.

      V. To establish a biospecimen repository archive: frozen peripheral blood live cells and
      plasma for future more detailed and comprehensive immunologic assays, including direct
      testing of anti-MUC1 T cell immunity.

      OUTLINE:

      Patients receive MUC1 peptide-Poly-ICLC vaccine subcutaneously (SC) at weeks 0, 2, and 10.

      After completion of study treatment, patients may be followed up at week 28.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Immunogenicity of the MUC1 Vaccine
time frame: At week 12
description: Will be evaluated by monitoring changes in IgG anti-MUC1 antibody titer ratio; defined as t12/t0, where t0 is the "initial titer" measured prior to vaccination, and t12 is the "final titer" drawn at 12 weeks. A titer ratio of >= 2 will be considered a positive response.
measure: Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment
time frame: 24 weeks
description: Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.0. The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. In addition, the number and severity of adverse events will be tabulated and summarized across all grades.
measure: Effect of Smoking Status on Vaccine Response
time frame: 12 weeks
description: To explore potential differences, if any, in the immunogenicity of the vaccine (as assessed at week 12 by the IgG anti-MUC1 antibody titer ratio) in current vs. former smokers.
measure: Pre-Vaccination Levels Versus Post-Vaccination Levels of Circulating Myeloid Derived Suppressor Cells (MDSC)
time frame: 12 weeks
description: Will correlate with the ability to respond to the vaccine. Will summarize the data using descriptive statistics and graphical methods (i.e. boxplots, scatter plots, etc.). For continuous MDSC data versus response data, will use t-tests or Wilcoxon Rank-Sum tests (for non-normal data).
measure: Chronic Obstructive Pulmonary Disease (COPD) Status
time frame: Baseline to week 12
description: Will explore the relationship between COPD status at pre-registration and immune response in current versus former smokers. In individuals with COPD, the severity of airflow obstruction will be measured by the pulmonary function tests as per the GOLD classification.
measure: Changes in Immunogenicity in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
time frame: Baseline up to week 12
description: Will explore whether or not changes in immunogenicity in individuals with COPD corresponds to different circulating MDSC levels.
measure: Impact of the MUC1/Poly-ICLC Vaccine on Inflammation-Related High Sensitivity C-Reactive Protein (hsCRP) and Interleukin-6 (IL-6)
time frame: Up to week 24
measure: Ability to Successfully Vaccinate With MUC1/Poly-ICLC Vaccine Depending on Baseline High Sensitivity C-Reactive Protein (hsCRP) and Interleukin-6 (IL-6) Levels
time frame: Up to week 24
arm group label: Prevention (MUC1 peptide-Poly-ICLC vaccine)
arm group type: Experimental
description: Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Prevention (MUC1 peptide-Poly-ICLC vaccine)
intervention type: Biological
intervention name: MUC1 Peptide-Poly-ICLC Vaccine
description: Given SC
arm group label: Prevention (MUC1 peptide-Poly-ICLC vaccine)
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Arjun Pennathur
role: Principal Investigator
affiliation: Mayo Clinic in Rochester
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Poly ICLC
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 