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

NCT04222309 | Suspended Phase 1

• 1 other identifier: 19-0801
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Glioma, Malignant; Glioblastoma; Glioblastoma Multiforme; Glioblastoma Multiforme of Brain; GBM; Brain Cancer

Keywords

blood brain barrier; omental free flap

Outcome Measures

Primary Outcomes (2)

• Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria

  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.

  Study Day 1-180

• Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection

  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.

  Time Frame: Study Day 1-180

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  6 months

• Overall Survival (OS)

  6 months

• Percent of screen fails

  Study Day 1 - 24 months

Study Arms (1)

Laparoscopically harvested omental free flap

EXPERIMENTAL

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

Interventions

Laparoscopically harvested omental free flap PROCEDURE

Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

Laparoscopically harvested omental free flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a male or female 18 years of age or older.
• Subject is undergoing planned resection of known or suspected GBM.
• Subject has a Karnofsky Performance Status (KPS) 70% or greater.
• Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
• Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
• Subject must be able to undergo MRI evaluation.
• Subject meets the following laboratory criteria:
• White blood count ≥ 3,000/µL
• Absolute neutrophil count ≥ 1,500/µL
• Platelets ≥ 100,000/µL
• Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed)
• Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN
• Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
• Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.

You may not qualify if:

• Subject, if female, is pregnant or is breast feeding.
• Subject intends to participate in another clinical trial.
• Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
• Subject has an active infection requiring treatment.
• Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
• 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
• Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
• 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.
• Subject has had prior abdominal surgery.
• Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
• Subject who are unable to have an MRI scan for any reason.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Brain Tumor Center

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Glioma; Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John Boockvar, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: January 6, 2020
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)