Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)

NCT05979064 | Recruiting

• 1 other identifier: 22-0994
• 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 laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

Conditions

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

Keywords

blood brain barrier; omentum autograft; omental autograft; omentum; omental

Outcome Measures

Primary Outcomes (2)

• Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM).

  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, 60 days, 120 days and 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.

  Study Day 1 - Day 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, 60 days, 120 days and 180 days.

  Study Day 1 - Day 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 tissue autograft

EXPERIMENTAL

Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients.

Procedure: Laparoscopically harvested omental tissue autograft

Interventions

Laparoscopically harvested omental tissue autograft PROCEDURE

1. Standard neurosurgical removal of recurrent GBM, 2. removal of fat from abdomen called omentum using a thin tube with a camera (laparoscopically), 3. the omental fat will be transferred and implanted into brain tumor cavity, 4. standard closure of surgical resection cavity.

Laparoscopically harvested omental tissue autograft

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 that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.
• 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

RECRUITING

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

Central Study Contacts

John Boockvar, MD

CONTACT

212-434-3900; jboockvar@northwell.edu

Tamika Wong, MPH

CONTACT

212-434-4836; twong4@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: July 31, 2023
• First Posted: August 7, 2023
• Study Start: April 4, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)