<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/NCT02264236</url>
  </required_header>
  <id_info>
    <org_study_id>203199</org_study_id>
    <secondary_id>203199</secondary_id>
    <nct_id>NCT02264236</nct_id>
  </id_info>
  <brief_title>Vaccination of Advanced-Stage Lung Cancer Patients</brief_title>
  <official_title>&quot;Vaccination of Advanced-Stage Lung Cancer Patients&quot; A Phase I/II Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching purpose of this study is to evaluate the clinical efficacy of an&#xD;
      investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with&#xD;
      standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung&#xD;
      Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG.&#xD;
      Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type&#xD;
      will be enrolled for this vaccine trial.&#xD;
&#xD;
      This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the&#xD;
      vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are:&#xD;
      (1) to monitor the safety and tolerability of the vaccine when it is administered in&#xD;
      combination with SoC therapy; and (2) to determine whether immunization with vaccine can&#xD;
      successfully elicit a robust immune response in subjects with advanced-stage lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Inability to enroll subjects under current iteration of the protocol&#xD;
  </why_stopped>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">June 2021</completion_date>
  <primary_completion_date type="Actual">June 2021</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>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 participants with vaccine related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</measure>
    <time_frame>64 weeks +/- 2 weeks per subject</time_frame>
    <description>The National Cancer Institute (NCI) of the National Institutes of Health (NIH) has published standardized definitions for adverse events (AEs), known as the Common Terminology Criteria for Adverse Events (CTCAE, also called &quot;common toxicity criteria&quot;), to describe the severity of organ toxicity for patients receiving cancer therapy. The tables describing AEs graded in the CTCAE (version 4.0) provides a references for adverse events reporting. From grade 1 AEs being minor/low grade adverse events to grade 5 AEs being serious adverse events usually resulting in death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with vaccine induced immune related response.</measure>
    <time_frame>64 weeks +/- 2 weeks per subject</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>P10s-PADRE vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be immunized by administration of either three or four doses of P10s-PADRE vaccine over a six-week period at a dose level of 500 micrograms (µg) per injection depending on the slandered of care therapy they receive for their lung cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>P10s-PADRE vaccine</intervention_name>
    <description>P10s-PADRE vaccine combined with MONTANIDE™ ISA 51 VG &quot;Chemotherapy&quot; Subcutaneous injection at weeks 2, 3, 5, and 6. &quot;3-Week Interval Immunotherapy&quot; Subcutaneous injection at weeks 2, 3, and 4. &quot;2-Week Interval Immunotherapy&quot; Subcutaneous injection at weeks 3, 4, and 5.</description>
    <arm_group_label>P10s-PADRE vaccine</arm_group_label>
    <other_name>Mimotope P10s-PADRE Vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Advanced-stage (i.e., metastatic) Lung Cancer of any histologic type&#xD;
&#xD;
          2. (Computed Tomography) CT scans were completed within 4 weeks prior to registration&#xD;
&#xD;
          3. Age 18 years and older&#xD;
&#xD;
          4. ECOG Performance Status 0 to 2&#xD;
&#xD;
          5. White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration&#xD;
&#xD;
          6. Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration&#xD;
&#xD;
          7. Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2&#xD;
             x institutional upper limit (IUL) of normal obtained within 3 weeks prior to&#xD;
             registration&#xD;
&#xD;
          8. Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test&#xD;
             (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to&#xD;
             registration&#xD;
&#xD;
          9. Serum creatinine ≤ 1.8 mg/dL obtained within 3 weeks prior to registration&#xD;
&#xD;
         10. Radiation is allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active infection requiring treatment with antibiotics&#xD;
&#xD;
          2. Any other significant medical or psychiatric conditions which, in the opinion of the&#xD;
             enrolling investigator, may interfere with consent or compliance of the treatment&#xD;
             regimen&#xD;
&#xD;
          3. Existing diagnosis or evidence of organic brain syndrome that might preclude&#xD;
             participation in the full protocol&#xD;
&#xD;
          4. Existing diagnosis or history of significant impairment of basal cognitive function&#xD;
             that might preclude participation in the full protocol&#xD;
&#xD;
          5. Existing diagnosis or history of leptomeningeal disease, spinal cord compression or&#xD;
             brain metastases unless: (a) metastases have been locally treated and have remained&#xD;
             clinically controlled and asymptomatic for at least 14 days following treatment, AND&#xD;
             (b) subject has no residual neurological dysfunction and has been off corticosteroids&#xD;
             for at least 14 days prior to registration&#xD;
&#xD;
          6. Other current malignancy(s): Subjects with prior history at any time of any in situ&#xD;
             cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ,&#xD;
             atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin&#xD;
             cancer are eligible, provided they are disease-free at the time of registration.&#xD;
             Subject has other malignancies have been continuously disease free for ≥ 5 years prior&#xD;
             to the time of registration. Subjects with other malignancies are eligible if they&#xD;
             have been continuously disease free for ≥ 5 years prior to the time of registration.&#xD;
&#xD;
          7. Active autoimmune disorders or conditions of immunosuppression; Existing autoimmune&#xD;
             disorders or conditions of immunosuppression that have been in remission for less than&#xD;
             6 months.&#xD;
&#xD;
          8. Treatment with corticosteroids, including oral steroids (i.e. prednisone,&#xD;
             dexamethasone), continuous use of topical steroid creams or ointments or any&#xD;
             steroid-containing inhalers. Subjects who have been on systemic steroids will require&#xD;
             a 6-week washout period. Subjects who discontinue the use of these classes of&#xD;
             medication for at least 6 weeks prior to registration are eligible if, in the judgment&#xD;
             of the treating physician, the subject is not likely to require these classes of drugs&#xD;
             during the treatment period. Replacement doses of steroids for subjects with adrenal&#xD;
             insufficiency are allowed.&#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>Konstantinos Arnaoutakis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</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>Vaccines</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/NCT02264236
org study id: 203199
secondary id: 203199
nct id: NCT02264236
lead sponsor: 
has dmc: Yes
The overarching purpose of this study is to evaluate the clinical efficacy of an
      investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with
      standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung
      Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG.
      Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type
      will be enrolled for this vaccine trial.

      This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the
      vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are:
      (1) to monitor the safety and tolerability of the vaccine when it is administered in
      combination with SoC therapy; and (2) to determine whether immunization with vaccine can
      successfully elicit a robust immune response in subjects with advanced-stage lung cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with vaccine related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
time frame: 64 weeks +/- 2 weeks per subject
description: The National Cancer Institute (NCI) of the National Institutes of Health (NIH) has published standardized definitions for adverse events (AEs), known as the Common Terminology Criteria for Adverse Events (CTCAE, also called "common toxicity criteria"), to describe the severity of organ toxicity for patients receiving cancer therapy. The tables describing AEs graded in the CTCAE (version 4.0) provides a references for adverse events reporting. From grade 1 AEs being minor/low grade adverse events to grade 5 AEs being serious adverse events usually resulting in death.
measure: Number of participants with vaccine induced immune related response.
time frame: 64 weeks +/- 2 weeks per subject
arm group label: P10s-PADRE vaccine
arm group type: Experimental
description: Subjects will be immunized by administration of either three or four doses of P10s-PADRE vaccine over a six-week period at a dose level of 500 micrograms (µg) per injection depending on the slandered of care therapy they receive for their lung cancer.
intervention type: Biological
intervention name: P10s-PADRE vaccine
description: P10s-PADRE vaccine combined with MONTANIDE™ ISA 51 VG "Chemotherapy" Subcutaneous injection at weeks 2, 3, 5, and 6. "3-Week Interval Immunotherapy" Subcutaneous injection at weeks 2, 3, and 4. "2-Week Interval Immunotherapy" Subcutaneous injection at weeks 3, 4, and 5.
arm group label: P10s-PADRE vaccine
other name: Mimotope P10s-PADRE Vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Konstantinos Arnaoutakis, MD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Vaccines