10 Participants Needed

Omental Tissue Autograft for Brain Tumor

TW
John Boockvar, MD profile photo
Overseen ByJohn Boockvar, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is omental tissue autograft generally safe for use in humans?

Omental tissue autografts have been used safely in various medical procedures, including brain surgeries and breast reconstruction, with studies showing no major complications and good recovery in patients. However, further research is needed to confirm long-term safety and effectiveness.12345

How is the omental tissue autograft treatment for brain tumors different from other treatments?

The omental tissue autograft treatment is unique because it involves using a patient's own omental tissue (a layer of fat that covers abdominal organs) to potentially support brain tumor treatment, which is different from traditional methods like chemotherapy or radiation that target the tumor directly.678910

What data supports the effectiveness of the treatment Laparoscopically harvested omental tissue autograft for brain tumors?

Research shows that omental tissue, when transplanted to the brain, can help bypass the blood-brain barrier (a protective shield around the brain) and promote healing by providing blood supply and growth factors. This technique has been used successfully in other conditions like Alzheimer's disease and skull base reconstruction, suggesting it may help in brain tumor treatment by improving blood flow and supporting tissue repair.1231112

Who Is on the Research Team?

John Andrew Boockvar, MD | Northwell Health

John Boockvar, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recurrent Grade IV glioblastoma multiforme (GBM) who are candidates for significant tumor resection and can undergo MRI scans. They must have a life expectancy of at least 6 months, meet specific lab criteria, and not be pregnant or breastfeeding. Exclusions include active infections, other clinical trials participation, prior abdominal surgery, or severe renal issues.

Inclusion Criteria

Subject meets 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, Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document
Subject must be able to undergo MRI evaluation
I am scheduled for surgery to remove a brain tumor suspected to be GBM.
See 4 more

Exclusion Criteria

Subject who are unable to have an MRI scan for any reason
Subject intends to participate in another clinical trial
I am currently being treated for an infection.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection and Omental Autograft

Standard surgical resection for diagnosed recurrent GBM followed by lining the surgical cavity with a laparoscopically harvested piece of autologous omentum

1 day
1 visit (in-person)

Immediate Post-Surgical Follow-up

Participants are monitored for side effects such as seizures, stroke, and infection within 72 hours post-surgery

3 days
1 visit (in-person)

Extended Follow-up

Participants are monitored for safety and effectiveness, including tumor progression and survival, at 7 days, 30 days, 60 days, 120 days, and 180 days post-surgery

6 months
5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Laparoscopically harvested omental tissue autograft
Trial Overview The study tests the safety of implanting laparoscopically harvested autologous omentum tissue into the cavity after GBM tumor resection. It's an early-phase trial to see if this approach is safe in patients with recurrent brain tumors.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Laparoscopically harvested omental tissue autograftExperimental Treatment1 Intervention
Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Published Research Related to This Trial

A new technique involving the transposition of vascularized omental tissue into the resection cavity of glioblastoma multiforme (GBM) patients has been shown to be feasible and safe in a phase I study with 2 patients, indicating potential for improved treatment options.
This method aims to bypass the blood-brain barrier and enhance immune surveillance of tumor antigens, with postoperative recovery allowing patients to return to baseline activities, although further research is needed to evaluate its impact on survival outcomes.
Cranial transposition and revascularization of autologous omentum: a novel surgical technique for resection of recurrent glioblastoma multiforme.Doron, O., Chen, T., Wong, T., et al.[2022]
A trial involving four patients demonstrated that using a transplanted vascularized omentum effectively reconstructs large skull base defects after tumor removal, preventing cerebrospinal fluid (CSF) leakage and infection.
The omentum is advantageous for its versatility in covering various defect sizes and shapes, and it contains growth factors that promote healing and tissue adhesion, enhancing the overall safety and efficacy of the reconstruction process.
[Reconstruction of skull base by omentum transplantation].Uede, T., Kashiwabara, S., Imaizumi, T., et al.[2006]
This study presents the first successful case of harvesting an omental-cerebellar pedicled graft using a laparoscopic technique, showcasing a new minimally invasive approach.
Laparoscopic surgery is changing the way surgical diseases are treated, allowing for procedures like omental harvest that were traditionally done through larger incisions, potentially leading to quicker recovery times and less postoperative pain.
Laparoscopic omental-cerebellar pedicled graft harvest.Frantzides, CT., Madan, AK., Ferguson, RL., et al.[2019]

Citations

Cranial transposition and revascularization of autologous omentum: a novel surgical technique for resection of recurrent glioblastoma multiforme. [2022]
[Reconstruction of skull base by omentum transplantation]. [2006]
Laparoscopic omental-cerebellar pedicled graft harvest. [2019]
The evolution of omentum transposition: from lymphedema to spinal cord, stroke and Alzheimer's disease. [2007]
5.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Microsurgical revascularization of the brain with an autograft of the greater omentum (experimental research)]. [2007]
Creating a Biological Breast Implant with an Omental Fat-Augmented Free Flap. [2022]
The Laparoscopically Harvested Omental Free Flap: A Compelling Option for Craniofacial and Cranial Base Reconstruction. [2020]
Organoids: A Platform Ready for Glioblastoma Precision Medicine? [2021]
Long-term culture of organotypic multicellular glioma spheroids: a good culture model for studying gliomas. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Interaction between rat glioma cells and normal rat brain tissue in organ culture. [2006]
[Transplantation and magnetic resonance imaging of transplantable human glioma tissue in the brain of nude mice]. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
Processing of Primary Patient Tumors and Subsequent Generation of Primary Cell Lines. [2020]
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