Using omental tissue to treat recurrent glioblastoma

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

This study is testing whether using a piece of fat from the abdomen can help improve treatment for patients with recurrent glioblastoma by delivering medication and immune cells more effectively to the tumor site.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwell Health (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (New York, New York)
• Trial ID: NCT05979064 on ClinicalTrials.gov

What this trial studies

This interventional study evaluates the safety of using laparoscopically harvested autologous omentum as a graft in patients undergoing resection for recurrent glioblastoma multiforme (GBM). The omental graft is hypothesized to enhance the delivery of chemotherapeutics and immune cells to the tumor site by circumventing the blood-brain barrier. The study will assess the feasibility and safety of this approach in a single-center, open-label format. The rich vascular supply of the omentum is expected to support healing and improve outcomes in patients with previously irradiated or infected surgical sites.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of recurrent glioblastoma who are eligible for significant surgical resection.

Not a fit: Patients with a Karnofsky Performance Status below 70% or those not suitable for surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with recurrent glioblastoma by enhancing drug delivery and immune response.

How similar studies have performed: While the use of omental grafts in head and neck cancers has shown success, this specific application in recurrent glioblastoma is novel and has not been extensively tested.

Eligibility 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 graft 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.

Where this trial is running

New York, New York

• Lenox Hill Brain Tumor Center — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: John Boockvar, MD — Northwell Health
• Study coordinator: John Boockvar, MD

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