<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/NCT03038828</url>
  </required_header>
  <id_info>
    <org_study_id>NMCSD2013.008_UCSF</org_study_id>
    <nct_id>NCT03038828</nct_id>
  </id_info>
  <brief_title>Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts</brief_title>
  <acronym>PAW</acronym>
  <official_title>Phase 1 Dose Escalation Study to Establish the Safety of Leukocyte Interleukin, Injection for Treatment of Perianal Warts in Adult Men and Women Who Are HIV/HPV Co-infected</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CEL-SCI Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ergomed Clinical Research Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Naval Medical Center, San Diego</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>CEL-SCI Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study is a dose escalation study. Fifteen patients will be enrolled in 2 treatment cohorts.&#xD;
      Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2&#xD;
      weeks, off 2 weeks, then again 5 days/week for 2 weeks. If no serious adverse events are&#xD;
      noted in cohort A patients, ten participants will be treated in cohort B. Cohort B&#xD;
      participants will be treated the same as cohort A participants except that dose will be&#xD;
      increased to 400IU Multikine per day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study is a dose escalation study to determine the safety of Leukocyte Interleukin, Injection&#xD;
      in treating men and women with perianal warts who are HIV/HPV co-infected. Fifteen patients&#xD;
      will be enrolled in 2 treatment cohorts. Five participants (cohort A) will be treated with&#xD;
      200IU Multikine daily, 5 days/week for 2 weeks, off 2 weeks, then treated again 5 days/week&#xD;
      for 2 weeks. If no serious adverse events are noted in cohort A patients, ten (10)&#xD;
      participants will be treated in cohort B. Cohort B participants will be treated in the same&#xD;
      manner as cohort A participants except that the dose will be increased to 400IU Multikine per&#xD;
      day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient enrollment&#xD;
  </why_stopped>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wart characterization change</measure>
    <time_frame>Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]</time_frame>
    <description>Perianal wart characterization includes counting the number of identified warts, the diameter measurement of each identified wart in millimeters and the photographic imaging of each identified wart during the treatment phase and the follow-up phase of the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of HPV subtype identification change</measure>
    <time_frame>Days 0, 4, 11, 32, 39, 70, 100 130, 160</time_frame>
    <description>HPV subtyping will be performed on specimens collected from the anal canal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Anal dysplasia cytologic grade change</measure>
    <time_frame>Days 0, 4, 11, 32, 39, 70, 100, 130, 160</time_frame>
    <description>Anal dysplasia cytologic specimen collection will take place during the treatment phase and the follow-up phase of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of adverse effects during the treatment phase of the study assessed</measure>
    <time_frame>Days 0, 4, 11, 32, 39, 70, 100, 130, 160</time_frame>
    <description>Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Perianal Warts</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Leukocyte Interleukin, Injection</intervention_name>
    <description>Immunotherapy</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Multikine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥18 years of age&#xD;
&#xD;
          2. Diagnosed with perianal condyloma by primary clinician&#xD;
&#xD;
          3. HIV-infected, may be on or off of antiretroviral therapy. Enrolment of subjects on&#xD;
             HAART will be restricted to those individuals for whom an alternative regimen can&#xD;
             reasonably be constructed in case of failure.&#xD;
&#xD;
          4. Negative reaction to intradermal test with ciprofloxacin (a fluoroquinolone&#xD;
             antibiotic)&#xD;
&#xD;
          5. Any CD4 count will be considered appropriate for study&#xD;
&#xD;
          6. Blood WBC &gt; 2.0x103/mm3 and absolute neutrophils count &gt; 500&#xD;
&#xD;
          7. Blood hemoglobin &gt; 10.0 g/dL&#xD;
&#xD;
          8. Blood platelet count &gt; 50x103/mm3&#xD;
&#xD;
          9. Serum total bilirubin &lt; 6.0 mg/dL (participants taking atazanavir-based ARV regimens&#xD;
             may have elevated total bilirubin but are generally &lt; 6)&#xD;
&#xD;
         10. Blood aspartate aminotransferase (AST) &lt; 100 U/L (&lt;2 ULN)&#xD;
&#xD;
         11. Blood alanine aminotransferase (ALT) &lt; 130 U/L (&lt;2 ULN)&#xD;
&#xD;
         12. Serum creatinine &lt; 1.5 mg/dL&#xD;
&#xD;
         13. ECOG performance status &lt; 3&#xD;
&#xD;
         14. If a subject is of reproductive potential he/she and her/his sexual partner MUST be&#xD;
             willing and able to utilize highly effective methods of contraception (e.g., birth&#xD;
             control pill, barrier methods with spermicide - as applicable) for the duration of the&#xD;
             study including the study follow-up period.&#xD;
&#xD;
         15. Subjects must be willing to refrain from anal sex, douching and use of enemas prior to&#xD;
             scheduled Pap smears&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anal cancer (current or history of)&#xD;
&#xD;
          2. Inability to attend study visits&#xD;
&#xD;
          3. Participation in any other drug study&#xD;
&#xD;
          4. History of asthma&#xD;
&#xD;
          5. History of CHF and/or cardiac support for arrhythmia or on chronic cardiac medication&#xD;
             or has other chronic or acute cardiac ailments (e.g., or abnormal EKG at Baseline)&#xD;
&#xD;
          6. History of organ transplantation or requiring chronic administration of immune&#xD;
             suppressive drugs in the last 6 months&#xD;
&#xD;
          7. For women, neither pregnant nor lactating&#xD;
&#xD;
          8. In the opinion of the Primary Investigator, the subject may not be able to tolerate&#xD;
             the study treatment regimen&#xD;
&#xD;
          9. Subjects who are currently using or have recently within past 3 months) been treated&#xD;
             with immunomodulators (e.g., Interferon-α)&#xD;
&#xD;
         10. Subjects with active infections including sexually transmitted diseases (e.g., N.&#xD;
             gonorrhea, C. trachomatis, H. ducreyi, T. pallidum)&#xD;
&#xD;
         11. History of allergic reaction to fluoroquinolone antibiotics (e.g., ciprofloxacin,&#xD;
             ofloxacin)&#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>Eyal Talor, PhD</last_name>
    <role>Study Director</role>
    <affiliation>CEL-SCI Chief Scientific Officer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134-5000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 8, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>May 8, 2022</last_update_submitted>
  <last_update_submitted_qc>May 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</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>Warts</mesh_term>
    <mesh_term>Condylomata Acuminata</mesh_term>
  </condition_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/NCT03038828
org study id: NMCSD2013.008_UCSF
nct id: NCT03038828
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Study is a dose escalation study. Fifteen patients will be enrolled in 2 treatment cohorts.
      Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2
      weeks, off 2 weeks, then again 5 days/week for 2 weeks. If no serious adverse events are
      noted in cohort A patients, ten participants will be treated in cohort B. Cohort B
      participants will be treated the same as cohort A participants except that dose will be
      increased to 400IU Multikine per day.
Study is a dose escalation study to determine the safety of Leukocyte Interleukin, Injection
      in treating men and women with perianal warts who are HIV/HPV co-infected. Fifteen patients
      will be enrolled in 2 treatment cohorts. Five participants (cohort A) will be treated with
      200IU Multikine daily, 5 days/week for 2 weeks, off 2 weeks, then treated again 5 days/week
      for 2 weeks. If no serious adverse events are noted in cohort A patients, ten (10)
      participants will be treated in cohort B. Cohort B participants will be treated in the same
      manner as cohort A participants except that the dose will be increased to 400IU Multikine per
      day.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: None (Open Label)
measure: Wart characterization change
time frame: Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
description: Perianal wart characterization includes counting the number of identified warts, the diameter measurement of each identified wart in millimeters and the photographic imaging of each identified wart during the treatment phase and the follow-up phase of the study
measure: Assessment of HPV subtype identification change
time frame: Days 0, 4, 11, 32, 39, 70, 100 130, 160
description: HPV subtyping will be performed on specimens collected from the anal canal.
measure: Assessment of Anal dysplasia cytologic grade change
time frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
description: Anal dysplasia cytologic specimen collection will take place during the treatment phase and the follow-up phase of the study
measure: Assessment of adverse effects during the treatment phase of the study assessed
time frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
description: Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log
arm group label: Arm A
arm group type: Experimental
description: Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks.
arm group label: Arm B
arm group type: Experimental
description: Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks.
intervention type: Biological
intervention name: Leukocyte Interleukin, Injection
description: Immunotherapy
arm group label: Arm A
arm group label: Arm B
other name: Multikine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eyal Talor, PhD
role: Study Director
affiliation: CEL-SCI Chief Scientific Officer
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Warts
mesh term: Condylomata Acuminata
sharing ipd: No