<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/NCT03003195</url>
  </required_header>
  <id_info>
    <org_study_id>206265</org_study_id>
    <nct_id>NCT03003195</nct_id>
  </id_info>
  <brief_title>The P10s-PADRE Basket Trial: Vaccination of Metastatic Cancer Patients</brief_title>
  <official_title>A Combined Phase I/II Study of a Carbohydrate Mimotope-Based Vaccine With MONTANIDE™ ISA 51 VG STERILE for Metastatic Cancer</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical efficacy of an investigational agent,&#xD;
      P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing Institutional Review Board (IRB) approved consent, subjects with metastatic&#xD;
      cancer will be enrolled. The vaccine doses will be prepared and dispensed by the University&#xD;
      of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions.&#xD;
      Subjects will receive 1.0 mL subcutaneous injections of the vaccine on 4 separate occasions.&#xD;
      The vaccine will be administered at rotating sites on the limbs or abdomen. The study will&#xD;
      last approximately 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of Funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2022</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>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 Immune Response</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Neoplasms by Site</condition>
  <condition>Metastatic Cancer</condition>
  <arm_group>
    <arm_group_label>Vaccination: P10s-PADRE/MONTANIDE ISA 51 VG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100mL vaccination on Weeks 1, 2, 3 and 8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P10s-PADRE</intervention_name>
    <description>All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection for a total of 4 vaccinations.</description>
    <arm_group_label>Vaccination: P10s-PADRE/MONTANIDE ISA 51 VG</arm_group_label>
    <other_name>MONTANIDE ISA 51 VG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of all races with clinical Stage IV cancer of any type, staged according to&#xD;
             American Joint Commission on Cancer (AJCC), sixth edition, receiving any line of&#xD;
             standard treatment for the specific cancer and with stable disease or better for at&#xD;
             least two months will be invited to participate.&#xD;
&#xD;
          -  Subjects of all races with clinical Stage IV cancer of any type, staged according to&#xD;
             American Joint Commission on Cancer (AJCC), sixth edition, who have no standard&#xD;
             treatment options for the specific cancer (Patients whose standard of care consists of&#xD;
             watchful waiting) and who fulfill the other eligibility criteria will be invited to&#xD;
             participate.&#xD;
&#xD;
          -  Measurable or evaluable disease.&#xD;
&#xD;
          -  Patients with bone-only disease will be allowed to participate.&#xD;
&#xD;
          -  Ages 18 years and older.&#xD;
&#xD;
          -  ECOG Performance status 0, 1 or 2.&#xD;
&#xD;
          -  White blood cells (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration&#xD;
&#xD;
          -  Platelet count ≥ 100,000/mm3 prior to registration&#xD;
&#xD;
          -  Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional upper limit (IUL)&#xD;
             of normal obtained within 3 weeks prior to registration or Aspartate aminotransferase&#xD;
             test (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks&#xD;
             prior to registration&#xD;
&#xD;
          -  Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks&#xD;
             prior to registration.&#xD;
&#xD;
          -  Serum creatinine ≤ 1.8 mg/dl obtained within 3 weeks prior to registration.&#xD;
&#xD;
          -  Must sign an informed consent document approved by UAMS Institutional Review Board&#xD;
             (IRB).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection requiring treatment with antibiotics.&#xD;
&#xD;
          -  Existing diagnosis or history of organic brain syndrome that precludes participation&#xD;
             in the full protocol.&#xD;
&#xD;
          -  Existing diagnosis or history of significant impairment of basal cognitive function&#xD;
             that might preclude participation in the full protocol.&#xD;
&#xD;
          -  Other current malignancies. Subjects with prior history at any time of any in situ&#xD;
             cancer, including lobular carcinoma in situ of the breast, cervical cancer in situ,&#xD;
             atypical melanocytic hyperplasia or Clark I melanoma in situ, or basal or squamous&#xD;
             skin cancer are eligible, provided they are disease-free of these other malignancies&#xD;
             at the time of registration. Subjects with other malignancies - other than the one for&#xD;
             which they are being treated - are eligible if they have been continuously disease&#xD;
             free (from the old cancer) for ≥ 5 years prior to the time of registration.&#xD;
&#xD;
          -  Existing diagnosis or history of autoimmune disorders or conditions of&#xD;
             immunosuppression. This includes, but is not limited to, being treated with&#xD;
             corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when&#xD;
             used as an antiemetic in standard therapy]), continuous use of topical steroid creams&#xD;
             or ointments or any steroid-containing inhalers. Subjects who have been on systemic&#xD;
             steroids will require a 6-week washout period. Subjects who discontinue the use of&#xD;
             these classes of medication for at least 6 weeks prior to registration are eligible&#xD;
             if, in the judgment of the treating physician, the subject is not likely to require&#xD;
             these classes of drugs during the treatment period. Replacement doses of steroids for&#xD;
             subjects with adrenal insufficiency are allowed.&#xD;
&#xD;
          -  Pregnancy or breast feeding, due to the unknown effects of peptide/mimotope vaccines&#xD;
             on a fetus or infant. Women of childbearing potential must have a negative urine&#xD;
             pregnancy test within 72 hours prior to receiving the first dose of study drug, and&#xD;
             must be counseled to use an accepted and effective method of contraception while on&#xD;
             treatment and for a period of 18 months after completing or discontinuing treatment.&#xD;
             Accepted methods include oral contraceptives, barrier method, IUDs, and abstinence.&#xD;
&#xD;
          -  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;
&#xD;
          -  Patients receiving checkpoint inhibitors.&#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>Issam Makhoul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 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>Neoplasm Metastasis</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neoplasms, Second Primary</mesh_term>
    <mesh_term>Neoplasms by Site</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Monatide (IMS 3015)</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03003195
org study id: 206265
nct id: NCT03003195
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the clinical efficacy of an investigational agent,
      P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer.
After signing Institutional Review Board (IRB) approved consent, subjects with metastatic
      cancer will be enrolled. The vaccine doses will be prepared and dispensed by the University
      of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions.
      Subjects will receive 1.0 mL subcutaneous injections of the vaccine on 4 separate occasions.
      The vaccine will be administered at rotating sites on the limbs or abdomen. The study will
      last approximately 12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Immune Response
time frame: 12 weeks
arm group label: Vaccination: P10s-PADRE/MONTANIDE ISA 51 VG
arm group type: Experimental
description: 100mL vaccination on Weeks 1, 2, 3 and 8
intervention type: Drug
intervention name: P10s-PADRE
description: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection for a total of 4 vaccinations.
arm group label: Vaccination: P10s-PADRE/MONTANIDE ISA 51 VG
other name: MONTANIDE ISA 51 VG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Issam Makhoul, MD
role: Principal Investigator
affiliation: University of Arkansas
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Neoplasms
mesh term: Neoplasms, Second Primary
mesh term: Neoplasms by Site
mesh term: Monatide (IMS 3015)
sharing ipd: No