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Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

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ClinicalTrials.gov Identifier: NCT04222309
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health

Brief Summary:

This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

All participants 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 omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.


Condition or disease Intervention/treatment Phase
Glioma Glioma, Malignant Glioblastoma Glioblastoma Multiforme Glioblastoma Multiforme of Brain GBM Brain Cancer Procedure: Laparoscopically harvested omental free flap Phase 1

Detailed Description:

Laparoscopically harvested omental free flaps are commonly used to fill surgical cavities after resection of head and neck cancers. The investigators hypothesize that a laparoscopically harvested omental free flap in 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 free flap with its long vascular pedicle length, wide rotational arc and available surface area 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 omental free makes it an ideal flap 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 blood vessels of the laparoscopically harvested omental free flap 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 omentum will also provide direct deposition of immune cells such as dendritic, macrophages and lymphocytes into the milieu of the resected GBM.

The investigators aim to prove that this commonly surgical technique for head and neck cancers is safe in a small human cohort of patients with resected recurrent GBM and may improve progression-free survival (PFS).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laparoscopically harvested omental free flap
  1. Standard neurosurgical removal of recurrent GBM,
  2. Removal of fat from the abdomen called omentum using a camera (laparoscopically),
  3. Lining the brain tumor cavity with the piece of omentum,
  4. Joining the blood vessels of the omentum to blood vessels in the scalp or neck to ensure that it maintains good blood flow.
Procedure: Laparoscopically harvested omental free flap
Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.




Primary Outcome Measures :
  1. Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria [ Time Frame: Study Day 1-180 ]
    Increase in tumor size relative to baseline will be measured using RANO and assessed by MRI throughout study at within 72 hours, 7 days, 30 days, 90 days and 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.

  2. Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection [ Time Frame: Time Frame: Study Day 1-180 ]
    Increase in seizures (defined as 15% relative to baseline), occurrence of a stroke, or occurrence of a severe infection will be determined throughout study within 72 hours, 7 days, 30 days, 90 days and 180 days.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 6 months ]
    The proportion of patients who are alive at 6 months from flap implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval.

  2. Overall Survival (OS) [ Time Frame: 6 months ]
    OS will be calculated as the time from treatment initiation (flap implantation) to the time of death.

  3. Percent of screen fails [ Time Frame: Study Day 1 - 24 months ]
    The number and percent of screen failures with the reason for screen failures (flap not viable etc.) will be tabulated and summarized.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is a male or female 18 years of age or older.
  2. Subject is undergoing planned resection of known or suspected GBM.
  3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
  4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
  5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
  6. Subject must be able to undergo MRI evaluation.
  7. Subject meets the following laboratory criteria:

    1. White blood count ≥ 3,000/µL
    2. Absolute neutrophil count ≥ 1,500/µL
    3. Platelets ≥ 100,000/µL
    4. Hemoglobin > 10.0 g/dL (transfusion and/or ESA allowed)
    5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
    6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
    7. Blood urea nitrogen (BUN) and creatinine < 1.5 x ULN
  8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
  9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document

Inclusion criteria considered during surgery:

  1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).
  2. Omental free flap is technically feasible.

Exclusion Criteria:

  1. Subject, if female, is pregnant or is breast feeding.
  2. Subject intends to participate in another clinical trial.
  3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
  4. Subject has an active infection requiring treatment.
  5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
  6. Subject has a history of other malignancy, unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
  7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
  8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  9. Subject has had prior abdominal surgery.
  10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
  11. Subject who are unable to have an MRI scan for any reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222309


Contacts
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Contact: John Boockvar, MD 212-434-4836 jboockvar@northwell.edu
Contact: Tamika Wong, MPH 212-434-4836 twong4@northwell.edu

Locations
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United States, New York
Lenox Hill Brain Tumor Center Recruiting
New York, New York, United States, 10075
Contact: John Boockvar, MD    212-434-3900    jboockvar@northwell.edu   
Contact: Tamika Wong, MPH    212-434-4836    twong4@northwell.edu   
Principal Investigator: John Boockvar, MD         
Sub-Investigator: David Langer, MD         
Sub-Investigator: Robert Andrews, MD         
Sub-Investigator: Christopher Filippi, MD         
Sub-Investigator: Sherese Fralin, MD         
Sub-Investigator: Tamika Wong, MPH         
Sub-Investigator: Mona Li         
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: John Boockvar, MD Northwell Health

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Responsible Party: John Boockvar, MD Zucker SOM @Hofstra/Northwell, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT04222309    
Other Study ID Numbers: 19-0801
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health:
blood brain barrier
omental free flap
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Glioblastoma
Glioma
Astrocytoma
Brain Diseases
Nervous System Diseases