xml: <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/NCT05979064</url>
    </required_header>
    <id_info>
      <org_study_id>22-0994</org_study_id>
      <nct_id>NCT05979064</nct_id>
    </id_info>
    <brief_title>Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)</brief_title>
    <official_title>Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northwell Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Northwell Health</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This single center, single arm, open-label, phase I study will assess the safety of&#xD;
        laparoscopically harvested autologous omentum, implanted into the resection cavity of&#xD;
        recurrent glioblastoma multiforme (GBM) patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Laparoscopically harvested omental grafts are commonly used to fill surgical cavities after&#xD;
        resection of head and neck cancers. We hypothesize that an omental tissue graft implanted&#xD;
        into our patients with resected recurrent GBM may be used as a readily available and&#xD;
        accessible means of circumventing the blood brain barrier (BBB) selectively and focally. The&#xD;
        laparoscopically harvested omental graft omentum would easily conform to many resected GBM&#xD;
        cavities in our human patients with acceptable risk. The predictable and rich vascular&#xD;
        anatomy of a laparoscopically harvested piece of omentum makes it an ideal tissue for cases&#xD;
        of previously irradiated and/or infected wound beds. This is why it is successfully used in&#xD;
        head and neck and skull base tumors. The permeability of the new blood vessels formed between&#xD;
        the omental graft and the cortical brain surface should allow for improved delivery of&#xD;
        chemotherapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular&#xD;
        space and microenvironment of the resected tumor cavity including the brain adjacent to the&#xD;
        tumor (BAT). Milky spots within the greater omentum are very small white-coloured areas of&#xD;
        lymphoid tissue will also provide direct deposition of immune cells such as dendritic,&#xD;
        macrophages and lymphocytes into the milieu of the resected GBM. The milky spots are made up&#xD;
        of mesenchymal cells and are covered in a layer of mesothelium. These structures surround the&#xD;
        small blood vessels. The enclosing mesothelium contains macrophages, lymphocytes and mast&#xD;
        cells. They are also known as secondary lymphoid organs. Most milky spots contain extremely&#xD;
        thin-walled lymphatic capillaries. In addition, the technique of fat grafting has been&#xD;
        reliably used since 1990 as a way to improve and enhance wound healing, scar healing, as well&#xD;
        as tissue augmentation and tissue repair following radiation injury.&#xD;
  &#xD;
        All subjects included in the study will undergo standard surgical resection for diagnosed&#xD;
        recurrent GBM. Following the resection, the surgical cavity will be lined with a&#xD;
        laparoscopically harvested piece of autologous omentum. The patient's dura, bone and scalp&#xD;
        will be closed as is customary. The subject will be followed for side effects within 72&#xD;
        hours, 7 days, 30 days, 60 days, 120 days and 180 days. Risk assessment will include seizure,&#xD;
        stroke, infection, tumor progression, and death.&#xD;
  &#xD;
        The investigators aim to prove that this commonly surgical technique for head and neck&#xD;
        cancers and reconstructive surgery is safe in a small human cohort of patients with resected&#xD;
        recurrent GBM and may improve progression-free survival (PFS) and overall survival (OS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 4, 2023</start_date>
    <completion_date type="Anticipated">April 2027</completion_date>
    <primary_completion_date type="Anticipated">April 2025</primary_completion_date>
    <phase>N/A</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>To assess the safety of lining the resection cavity with a laparoscopally harvested omental graft for recurrent glioblastoma multiforme (rGBM).</measure>
      <time_frame>Study Day 1 - Day 180</time_frame>
      <description>Safety parameters such as an increase in seizures (15%) relative to baseline, occurrence of a stroke, severe infection, or a rapidly progressive disease (25% growth relative to baseline, by RANO criteria) as assessed by MRI will be tabulated and summarized at the various time points of interest, if applicable-72 hours, 7, 30, 60, 120 and 180 days. Proportions of subjects experiencing these events will be estimated using standard methods for proportions, along with the associated exact 95% confidence intervals.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To estimate the progression free survival (PFS) at 6 months.</measure>
      <time_frame>6 months</time_frame>
      <description>The proportion of patients who are alive at 6 months from omental implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To estimate overall survival (OS).</measure>
      <time_frame>6 months</time_frame>
      <description>OS will be calculated as the time from treatment initiation (omental autograft) to the time of death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent of screen fails</measure>
      <time_frame>Study Day 1 - 24 Months</time_frame>
      <description>To tabulate the number and % of screen failures and understand the reason for screen failures (omental autograft not viable etc.)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Glioma</condition>
    <condition>Glioma, Malignant</condition>
    <condition>Glioblastoma</condition>
    <condition>Glioblastoma Multiforme</condition>
    <condition>Glioblastoma Multiforme of Brain</condition>
    <condition>GBM</condition>
    <condition>Brain Cancer</condition>
    <condition>High Grade Glioma</condition>
    <arm_group>
      <arm_group_label>Laparoscopically harvested omental tissue autograft</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparoscopically harvested omental tissue autograft</intervention_name>
      <description>Standard neurosurgical removal of recurrent GBM,&#xD;
  removal of fat from abdomen called omentum using a thin tube with a camera (laparascopically),&#xD;
  the omental fat will be transferred and implanted into brain tumor cavity,&#xD;
  standard closure of surgical resection cavity.</description>
      <arm_group_label>Laparoscopically harvested omental tissue autograft</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject is a male or female 18 years of age or older.&#xD;
  &#xD;
            2. Subject is undergoing planned resection of known or suspected GBM.&#xD;
  &#xD;
            3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.&#xD;
  &#xD;
            4. Subject has a life expectancy of at least 6 months, in the opinion of the&#xD;
               Investigator.&#xD;
  &#xD;
            5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for&#xD;
               ≥ 80% resection of enhancing region.&#xD;
  &#xD;
            6. Subject must be able to undergo MRI evaluation.&#xD;
  &#xD;
            7. Subject meets the following laboratory criteria:&#xD;
  &#xD;
                 1. White blood count ≥ 3,000/μL&#xD;
  &#xD;
                 2. Absolute neutrophil count ≥ 1,500/μL&#xD;
  &#xD;
                 3. Platelets ≥ 100,000/μL&#xD;
  &#xD;
                 4. Hemoglobin &gt; 10.0 g/dL (transfusion and/or ESA allowed)&#xD;
  &#xD;
                 5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal&#xD;
                    (ULN)&#xD;
  &#xD;
                 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) &lt; 3 x ULN&#xD;
  &#xD;
                 7. Blood urea nitrogen (BUN) and creatinine &lt; 1.5 x ULN&#xD;
  &#xD;
            8. Females of reproductive potential must have a negative serum pregnancy test and be&#xD;
               willing to use an acceptable method of birth control.&#xD;
  &#xD;
            9. Able to understand and willing to sign an institutional review board (IRB)- approved&#xD;
               written informed consent document&#xD;
  &#xD;
          Inclusion criteria considered during surgery:&#xD;
  &#xD;
            1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO&#xD;
               Grade IV glioblastoma multiforme (GBM).&#xD;
  &#xD;
            2. Omental graft is technically feasible.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject, if female, is pregnant or is breast feeding.&#xD;
  &#xD;
            2. Subject intends to participate in another clinical trial.&#xD;
  &#xD;
            3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this&#xD;
               surgery.&#xD;
  &#xD;
            4. Subject has an active infection requiring treatment.&#xD;
  &#xD;
            5. Subject has radiographic evidence of multi-focal disease or leptomeningeal&#xD;
               dissemination.&#xD;
  &#xD;
            6. Subject has a history of other malignancy, unless the patient has been disease- free&#xD;
               for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin&#xD;
               cancer is acceptable regardless of time, as well as localized prostate carcinoma or&#xD;
               cervical carcinoma in situ after curative treatment&#xD;
  &#xD;
            7. Subject has a known positive test for human immunodeficiency virus infection, or&#xD;
               active hepatitis B or hepatitis C infection.&#xD;
  &#xD;
            8. Subject has a history or evidence of any other clinically significant disorder,&#xD;
               condition or disease that would pose a risk to subject safety or interfere with the&#xD;
               study evaluation, procedures or completion.&#xD;
  &#xD;
            9. Subject has had prior abdominal surgery.&#xD;
  &#xD;
           10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.&#xD;
  &#xD;
           11. Subject who are unable to have an MRI scan for any reason.&#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>John Boockvar, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Northwell Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>John Boockvar, MD</last_name>
      <phone>212-434-3900</phone>
      <email>jboockvar@northwell.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tamika Wong, MPH</last_name>
      <phone>212-434-4836</phone>
      <email>twong4@northwell.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Lenox Hill Brain Tumor Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10075</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>John Boockvar, MD</last_name>
        <phone>212-434-3900</phone>
        <email>jboockvar@northwell.edu</email>
      </contact>
      <contact_backup>
        <last_name>Tamika Wong, MPH</last_name>
        <phone>212-434-4836</phone>
        <email>twong4@northwell.edu</email>
      </contact_backup>
      <investigator>
        <last_name>John Boockvar, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>David Langer, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robert A Andrews, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Netanel Ben-Shalom, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Avraham Zlochower, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tamika Wong, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Vadim Zhigin, PA-C</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Olivia Albers, NP</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Amy McKeown, NP</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Northwell Health</investigator_affiliation>
      <investigator_full_name>John Boockvar, MD Zucker SOM @Hofstra/Northwell</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>blood brain barrier</keyword>
    <keyword>omentum autograft</keyword>
    <keyword>omental autograft</keyword>
    <keyword>omentum</keyword>
    <keyword>omental</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioblastoma</mesh_term>
      <mesh_term>Glioma</mesh_term>
      <mesh_term>Brain Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979064
  org study id: 22-0994
  nct id: NCT05979064
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This single center, single arm, open-label, phase I study will assess the safety of
        laparoscopically harvested autologous omentum, implanted into the resection cavity of
        recurrent glioblastoma multiforme (GBM) patients.
  Laparoscopically harvested omental grafts are commonly used to fill surgical cavities after
        resection of head and neck cancers. We hypothesize that an omental tissue graft implanted
        into our patients with resected recurrent GBM may be used as a readily available and
        accessible means of circumventing the blood brain barrier (BBB) selectively and focally. The
        laparoscopically harvested omental graft omentum would easily conform to many resected GBM
        cavities in our human patients with acceptable risk. The predictable and rich vascular
        anatomy of a laparoscopically harvested piece of omentum makes it an ideal tissue for cases
        of previously irradiated and/or infected wound beds. This is why it is successfully used in
        head and neck and skull base tumors. The permeability of the new blood vessels formed between
        the omental graft and the cortical brain surface should allow for improved delivery of
        chemotherapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular
        space and microenvironment of the resected tumor cavity including the brain adjacent to the
        tumor (BAT). Milky spots within the greater omentum are very small white-coloured areas of
        lymphoid tissue will also provide direct deposition of immune cells such as dendritic,
        macrophages and lymphocytes into the milieu of the resected GBM. The milky spots are made up
        of mesenchymal cells and are covered in a layer of mesothelium. These structures surround the
        small blood vessels. The enclosing mesothelium contains macrophages, lymphocytes and mast
        cells. They are also known as secondary lymphoid organs. Most milky spots contain extremely
        thin-walled lymphatic capillaries. In addition, the technique of fat grafting has been
        reliably used since 1990 as a way to improve and enhance wound healing, scar healing, as well
        as tissue augmentation and tissue repair following radiation injury.
  
        All subjects included in the study will undergo standard surgical resection for diagnosed
        recurrent GBM. Following the resection, the surgical cavity will be lined with a
        laparoscopically harvested piece of autologous omentum. The patient's dura, bone and scalp
        will be closed as is customary. The subject will be followed for side effects within 72
        hours, 7 days, 30 days, 60 days, 120 days and 180 days. Risk assessment will include seizure,
        stroke, infection, tumor progression, and death.
  
        The investigators aim to prove that this commonly surgical technique for head and neck
        cancers and reconstructive surgery is safe in a small human cohort of patients with resected
        recurrent GBM and may improve progression-free survival (PFS) and overall survival (OS).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To assess the safety of lining the resection cavity with a laparoscopally harvested omental graft for recurrent glioblastoma multiforme (rGBM).
  time frame: Study Day 1 - Day 180
  description: Safety parameters such as an increase in seizures (15%) relative to baseline, occurrence of a stroke, severe infection, or a rapidly progressive disease (25% growth relative to baseline, by RANO criteria) as assessed by MRI will be tabulated and summarized at the various time points of interest, if applicable-72 hours, 7, 30, 60, 120 and 180 days. Proportions of subjects experiencing these events will be estimated using standard methods for proportions, along with the associated exact 95% confidence intervals.
  measure: To estimate the progression free survival (PFS) at 6 months.
  time frame: 6 months
  description: The proportion of patients who are alive at 6 months from omental implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval.
  measure: To estimate overall survival (OS).
  time frame: 6 months
  description: OS will be calculated as the time from treatment initiation (omental autograft) to the time of death.
  measure: Percent of screen fails
  time frame: Study Day 1 - 24 Months
  description: To tabulate the number and % of screen failures and understand the reason for screen failures (omental autograft not viable etc.)
  arm group label: Laparoscopically harvested omental tissue autograft
  arm group type: Experimental
  description: Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients.
  intervention type: Procedure
  intervention name: Laparoscopically harvested omental tissue autograft
  description: Standard neurosurgical removal of recurrent GBM,
  removal of fat from abdomen called omentum using a thin tube with a camera (laparascopically),
  the omental fat will be transferred and implanted into brain tumor cavity,
  standard closure of surgical resection cavity.
  arm group label: Laparoscopically harvested omental tissue autograft
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: John Boockvar, MD
  role: Principal Investigator
  affiliation: Northwell Health
  last name: John Boockvar, MD
  phone: 212-434-3900
  email: jboockvar@northwell.edu
  last name: Tamika Wong, MPH
  phone: 212-434-4836
  email: twong4@northwell.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Northwell Health
  investigator full name: John Boockvar, MD Zucker SOM @Hofstra/Northwell
  investigator title: Principal Investigator
  mesh term: Glioblastoma
  mesh term: Glioma
  mesh term: Brain Neoplasms
  sharing ipd: No