<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/NCT03267680</url>
  </required_header>
  <id_info>
    <org_study_id>5GYN-16-2</org_study_id>
    <secondary_id>NCI-2017-01402</secondary_id>
    <secondary_id>5GYN-16-2</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT03267680</nct_id>
  </id_info>
  <brief_title>IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3</brief_title>
  <official_title>A Two-Cohort Randomized Phase 2 Trial of the IRX-2 Regimen in Women With Squamous Cervical Intraepithelial Neoplasia 3 (CIN 3) or Vulvar Intraepithelial Neoplasia 3 (VIN 3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brooklyn ImmunoTherapeutics, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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 randomized phase II trial studies how well an IRX-2 Regimen works in treating women with&#xD;
      cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3.&#xD;
      The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of&#xD;
      indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived&#xD;
      biologic with multiple active cytokine components, may act as an immune booster to stimulate&#xD;
      the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical&#xD;
      squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the proportion of subjects who achieve a pathologic complete response (CR) or&#xD;
      partial response (PR) in regimen 1 versus regimen 2 at week 25, based on the resected&#xD;
      surgical specimen.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the toxicity and feasibility of administration of IRX-2 in subjects with&#xD;
      confirmed cervical intraepithelial neoplasia (CIN) 3 or vulvar intraepithelial neoplasia&#xD;
      (VIN) 3.&#xD;
&#xD;
      II. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the&#xD;
      treatment of CIN 3 or VIN 3: the occurrence of clinical CRs or PRs at weeks 6, 13 and 25.&#xD;
&#xD;
      III. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the&#xD;
      treatment of CIN 3 or VIN 3: frequency of elimination of human papillomavirus (HPV) in&#xD;
      cervical or vulvar tissue using a commercial HPV genotyping assay and viral load&#xD;
      determination by quantitative polymerase chain reaction (PCR).&#xD;
&#xD;
      IV. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the&#xD;
      treatment of CIN 3 or VIN 3: analysis of the immune infiltrates in the resected surgical&#xD;
      specimens.&#xD;
&#xD;
      V. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the&#xD;
      treatment of CIN 3 or VIN 3: immunophenotypic analysis of peripheral blood lymphocytes.&#xD;
&#xD;
      VI. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the&#xD;
      treatment of CIN 3 or VIN 3: frequency of serum antibodies to HPV E6, E7 and L1 proteins by&#xD;
      enzyme-linked immunosorbent assay (ELISA).&#xD;
&#xD;
      VII. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the&#xD;
      treatment of CIN 3 or VIN 3: ribonucleic acid (RNA) expression profiling of&#xD;
      immune-inflammatory markers from post-treatment resected surgical specimens.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      Arm I: Patients receive cyclophosphamide intravenously (IV) on day 1 and IRX-2 via submucosal&#xD;
      injections in the cervix or subcutaneously (SC) for vulvar lesions on days 4-7. Patients also&#xD;
      receive indomethacin orally (PO) three times daily (TID), zinc-containing multivitamins (PO)&#xD;
      once daily (QD) and omeprazole orally (PO) on days 1-21.&#xD;
&#xD;
      Arm II: Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections&#xD;
      in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO&#xD;
      TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21.&#xD;
&#xD;
      In both arms, treatment repeats every 6 weeks for up to 2 courses in the absence of disease&#xD;
      progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 1-8 weeks after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Anticipated">November 8, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 8, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathologic response</measure>
    <time_frame>Week 25</time_frame>
    <description>Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events of IRX-2 administration</measure>
    <time_frame>Up to week 25</time_frame>
    <description>Will be assessed by the incidence and severity of adverse events, serious adverse events, as classified and graded according to the current version of the Common Terminology Criteria for Adverse Events version 4.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Cervical Squamous Cell Carcinoma In Situ</condition>
  <condition>Vulvar High Grade Squamous Intraepithelial Lesion</condition>
  <arm_group>
    <arm_group_label>Arm I (IRX-2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm I (IRX-2)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indomethacin</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm I (IRX-2)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IRX-2</intervention_name>
    <description>Given via submucosal injection or SC</description>
    <arm_group_label>Arm I (IRX-2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm I (IRX-2)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multivitamin</intervention_name>
    <description>Given zinc-containing multivitamin PO</description>
    <arm_group_label>Arm I (IRX-2)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <other_name>Geritol</other_name>
    <other_name>Vitamin Supplements (NOS)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omeprazole</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm I (IRX-2)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Given via submucosal injections or SC</description>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <other_name>placebo therapy</other_name>
    <other_name>sham therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Therapeutic Conventional Surgery</intervention_name>
    <description>Undergo surgical resection</description>
    <arm_group_label>Arm I (IRX-2)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed squamous CIN 3, or VIN 3 (usual type only)&#xD;
&#xD;
          -  The subject is either surgically sterile, postmenopausal, or agrees to practice an&#xD;
             effective method of birth control as determined by the investigator (to be continued&#xD;
             throughout the study period), except that subjects with CIN 3 are not permitted to use&#xD;
             a cervical cap or diaphragm for contraception&#xD;
&#xD;
          -  White blood cell &gt; 2,500/ mcL (&gt; 2.5 x 10^9/L)&#xD;
&#xD;
          -  Absolute neutrophil count &gt; 1,000/ microliter (&gt; 1 x 10^9/L)&#xD;
&#xD;
          -  Platelet count &gt; 75,000/ mcL (&gt; 75 x 10^9/L)&#xD;
&#xD;
          -  Hemoglobin &gt;= 8 g/dL (&gt;= 80 g/L) (subjects who have received a transfusion or&#xD;
             erythropoietin up to one week prior to receiving the first dose of cyclophosphamide&#xD;
             are eligible for the study)&#xD;
&#xD;
          -  International normalized ration (INR) or prothrombin time (PT) &lt; 1.5 x ULN (upper&#xD;
             limit of normal)&#xD;
&#xD;
          -  Activated partial thromboplastin time (aPTT) &lt; 1.5 x ULN&#xD;
&#xD;
          -  Serum creatinine &lt; 1.5 x ULN&#xD;
&#xD;
          -  Total bilirubin &lt; 2.0 x ULN unless thought to be related to inherited bilirubin&#xD;
             conjugation disorder (ie Gilbert?s disease)&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) &lt; 2.5 x ULN&#xD;
&#xD;
          -  The subject is geographically accessible for ongoing follow-up and is committed to&#xD;
             comply with the designated visits&#xD;
&#xD;
          -  The subject is capable of understanding and complying with the protocol and has signed&#xD;
             the enrollment informed consent form at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For subjects with cervical dysplasia: evidence of atypical glandular cells or&#xD;
             adenocarcinoma in situ (ACIS) based on cervical cytology, colposcopy or biopsy&#xD;
&#xD;
          -  For subjects with either cervical or vulvar squamous dysplasia: evidence of&#xD;
             microinvasive squamous carcinoma based on cytology, colposcopy or biopsy&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Allergy to ciprofloxacin or other quinolones (because ciprofloxacin is used in&#xD;
             preparation of IRX-2)&#xD;
&#xD;
          -  Allergy to indomethacin (a necessary component of the regimen) or to acetylsalicylic&#xD;
             acid (aspirin) due to likely allergy cross-reaction&#xD;
&#xD;
          -  Aldara (imiquimod) for the topical treatment of lower genital tract warts or dysplasia&#xD;
             within 3 months of study enrollment&#xD;
&#xD;
          -  Known to be positive for human immunodeficiency virus-1 (HIV-1) antibody, human&#xD;
             immunodeficiency virus-2 (HIV-2) antibody, hepatitis B surface antigen, or hepatitis C&#xD;
             virus antibody&#xD;
&#xD;
          -  Known to have other immunodeficiency diseases, including cellular immunodeficiencies,&#xD;
             hypogammaglobulinemia, or dysgammaglobulinemia&#xD;
&#xD;
          -  Immunotherapy (eg, interferons, tumor necrosis factor, interleukins) or biological&#xD;
             response modifiers (granulocyte-macrophage colony-stimulating factor, granulocyte&#xD;
             colony-stimulating factor, macrophage colony-stimulating factor) or any&#xD;
             investigational drug within 3 months of study enrollment&#xD;
&#xD;
          -  Concurrent treatment with systemic corticosteroids at a dose of &gt;= 5 mg/day of&#xD;
             prednisone (or equivalent)&#xD;
&#xD;
          -  Subjects should not take aspirin (except for low-dose aspirin as prescribed for&#xD;
             vascular disease) or other non-prescribed, non-steroidal anti-inflammatory agents from&#xD;
             randomization to surgery&#xD;
&#xD;
          -  An infectious process or any other significant illness such as an autoimmune disease&#xD;
             or advanced age that in the opinion of the investigator would compromise the subject?s&#xD;
             ability to mount an immune response&#xD;
&#xD;
          -  Impaired hepatic, renal or hematological function, evidenced by:&#xD;
&#xD;
               -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total&#xD;
                  bilirubin &gt;= 2 times upper limit of normal (ULN),&#xD;
&#xD;
               -  Serum creatinine &gt;= 2 times ULN, or&#xD;
&#xD;
          -  Clinically significant active cardiovascular disease, including a history of&#xD;
             myocardial infarction within the past 6 months, heart failure as defined by New York&#xD;
             Heart Association classes III or IV, and/or blood pressure greater than 160/90 mm Hg&#xD;
             (1 repeat measure allowed no more than 5 minutes after the first measurement)&#xD;
&#xD;
          -  History of severe allergic reaction to insect bites or stings, or to any biologic&#xD;
             pharmaceutical product, including compounds similar to the test article&#xD;
&#xD;
          -  Any medical contraindications, allergies or previous therapy that would preclude&#xD;
             treatment with the components of the IRX-2 regimen, i.e., cyclophosphamide,&#xD;
             indomethacin, zinc-containing multivitamins or omeprazole&#xD;
&#xD;
          -  Donation or loss of &gt; 450 mL of blood or plasma within 30 days of randomization&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynda Roman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center, Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>September 3, 2023</last_update_submitted>
  <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 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>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Indomethacin</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Omeprazole</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/NCT03267680
org study id: 5GYN-16-2
secondary id: NCI-2017-01402
secondary id: 5GYN-16-2
secondary id: P30CA014089
nct id: NCT03267680
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with
      cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3.
      The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of
      indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived
      biologic with multiple active cytokine components, may act as an immune booster to stimulate
      the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical
      squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.
PRIMARY OBJECTIVES:

      I. To compare the proportion of subjects who achieve a pathologic complete response (CR) or
      partial response (PR) in regimen 1 versus regimen 2 at week 25, based on the resected
      surgical specimen.

      SECONDARY OBJECTIVES:

      I. To evaluate the toxicity and feasibility of administration of IRX-2 in subjects with
      confirmed cervical intraepithelial neoplasia (CIN) 3 or vulvar intraepithelial neoplasia
      (VIN) 3.

      II. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the
      treatment of CIN 3 or VIN 3: the occurrence of clinical CRs or PRs at weeks 6, 13 and 25.

      III. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the
      treatment of CIN 3 or VIN 3: frequency of elimination of human papillomavirus (HPV) in
      cervical or vulvar tissue using a commercial HPV genotyping assay and viral load
      determination by quantitative polymerase chain reaction (PCR).

      IV. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the
      treatment of CIN 3 or VIN 3: analysis of the immune infiltrates in the resected surgical
      specimens.

      V. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the
      treatment of CIN 3 or VIN 3: immunophenotypic analysis of peripheral blood lymphocytes.

      VI. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the
      treatment of CIN 3 or VIN 3: frequency of serum antibodies to HPV E6, E7 and L1 proteins by
      enzyme-linked immunosorbent assay (ELISA).

      VII. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the
      treatment of CIN 3 or VIN 3: ribonucleic acid (RNA) expression profiling of
      immune-inflammatory markers from post-treatment resected surgical specimens.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      Arm I: Patients receive cyclophosphamide intravenously (IV) on day 1 and IRX-2 via submucosal
      injections in the cervix or subcutaneously (SC) for vulvar lesions on days 4-7. Patients also
      receive indomethacin orally (PO) three times daily (TID), zinc-containing multivitamins (PO)
      once daily (QD) and omeprazole orally (PO) on days 1-21.

      Arm II: Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections
      in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO
      TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21.

      In both arms, treatment repeats every 6 weeks for up to 2 courses in the absence of disease
      progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.

      After completion of study treatment, patients are followed up at 1-8 weeks after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pathologic response
time frame: Week 25
description: Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).
measure: Incidence of adverse events of IRX-2 administration
time frame: Up to week 25
description: Will be assessed by the incidence and severity of adverse events, serious adverse events, as classified and graded according to the current version of the Common Terminology Criteria for Adverse Events version 4.
arm group label: Arm I (IRX-2)
arm group type: Experimental
description: Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.
arm group label: Arm II (placebo)
arm group type: Active Comparator
description: Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.
intervention type: Drug
intervention name: Cyclophosphamide
description: Given IV
arm group label: Arm I (IRX-2)
arm group label: Arm II (placebo)
intervention type: Drug
intervention name: Indomethacin
description: Given PO
arm group label: Arm I (IRX-2)
arm group label: Arm II (placebo)
intervention type: Biological
intervention name: IRX-2
description: Given via submucosal injection or SC
arm group label: Arm I (IRX-2)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm I (IRX-2)
arm group label: Arm II (placebo)
intervention type: Dietary Supplement
intervention name: Multivitamin
description: Given zinc-containing multivitamin PO
arm group label: Arm I (IRX-2)
arm group label: Arm II (placebo)
other name: Geritol
other name: Vitamin Supplements (NOS)
intervention type: Drug
intervention name: Omeprazole
description: Given PO
arm group label: Arm I (IRX-2)
arm group label: Arm II (placebo)
intervention type: Other
intervention name: Placebo
description: Given via submucosal injections or SC
arm group label: Arm II (placebo)
other name: placebo therapy
other name: sham therapy
intervention type: Procedure
intervention name: Therapeutic Conventional Surgery
description: Undergo surgical resection
arm group label: Arm I (IRX-2)
arm group label: Arm II (placebo)
criteria: 
gender: Female
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Lynda Roman, MD
role: Principal Investigator
affiliation: University of Southern California
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Indomethacin
mesh term: Cyclophosphamide
mesh term: Omeprazole