Omental Tissue Autograft for Brain Tumor

Overseen By John Boockvar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Active infection, Other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of using a piece of the patient's own abdominal fat tissue, known as a laparoscopically harvested omental tissue autograft, to help treat brain tumors. It specifically targets individuals with recurring glioblastoma, a type of brain cancer. After tumor removal, the study involves placing this tissue into the space left behind to assess its potential in aiding healing or treatment. Individuals with recurring glioblastoma planning to have surgery to remove at least 80% of the tumor may be suitable candidates for this trial. This approach could offer a new way to support recovery after tumor removal. As an unphased trial, it provides a unique opportunity to explore innovative treatment options for glioblastoma recovery.

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.

What prior data suggests that this omental tissue autograft is safe for brain tumor patients?

Research has shown that using tissue from the abdomen, known as omental tissue, is generally well-tolerated in patients with brain tumors. Surgeons take this tissue through a small procedure to fill spaces left by surgery. Studies indicate that this method carries an acceptable level of risk.

In early tests, researchers tried this procedure on two patients, successfully moving the tissue to the brain area without major problems. These initial results suggest the procedure is safe enough for further investigation.

As this trial is an early-stage study, the main goal is to ensure safety. Early trials like this focus on testing the treatment's safety in humans. While data is limited, existing results are promising for those considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for recurrent glioblastoma multiforme (rGBM), which typically include surgery, radiation, and chemotherapy, the new approach of using laparoscopically harvested omental tissue autografts offers a unique twist. This technique involves transplanting a piece of the patient's own omental tissue into the brain cavity after tumor removal. The excitement around this treatment stems from the potential for the omental tissue to enhance healing and possibly deliver essential growth factors that can help repair the affected brain area. Researchers are eager to see if this approach can improve outcomes for rGBM patients where traditional methods often fall short.

What evidence suggests that this omental tissue autograft is effective for recurrent glioblastoma multiforme?

Research suggests that omental tissue, a fatty layer in the abdomen known for its healing properties, might help treat recurrent glioblastoma multiforme (GBM), a type of brain tumor. Earlier studies showed that this tissue fits well into the spaces left in the brain after tumor removal, potentially aiding in better healing. In this trial, participants will receive a laparoscopically harvested omental tissue autograft to evaluate its safety and effectiveness. The omentum's natural healing abilities make it a promising option for future therapies. ^{1 2 3 5 6}

Who Is on the Research Team?

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.

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.

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?

Group I: Laparoscopically harvested omental tissue autograft Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

The study introduces organotypic multicellular spheroids (OMS) as a more representative culture model for gliomas, which maintains the tumor's histological and immunocytochemical characteristics for up to 16 weeks, unlike traditional monolayer cultures.

Despite some changes, such as the appearance of GFAP-negative cells and the loss of capillaries over time, OMS effectively preserve tumor cell heterogeneity and composition, making them a valuable tool for studying gliomas in a laboratory setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term culture of organotypic multicellular glioma spheroids: a good culture model for studying gliomas. Kaaijk, P., Troost, D., Das, PK., et al.[2019]

The protocol outlined for processing and disassociating patient glioma tissue is crucial for creating clinically relevant specimens for research, impacting the success of patient-derived xenografts and neurosphere cultures.

This detailed method enhances the efficiency and effectiveness of generating viable glioma models for in vitro and in vivo studies, which is essential for advancing cancer research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processing of Primary Patient Tumors and Subsequent Generation of Primary Cell Lines. Gosa, L., Ta, L., Nathanson, DA.[2020]

The omentum has beneficial effects on the central nervous system, including properties like edema absorption and angiogenic activity, which may help in treating neurological conditions.

Omental transposition (OT) is being explored as a potential treatment for Alzheimer's disease, suggesting it could serve as an interim solution while more advanced therapies are developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of omentum transposition: from lymphedema to spinal cord, stroke and Alzheimer's disease. Goldsmith, HS.[2007]

The study successfully established a human glioma orthotopic transplantation model in nude mice with a high success rate of 93%, allowing for easier and faster tumor model preparation compared to previous methods.

Magnetic resonance imaging (MRI) effectively detected and measured tumor size and location, achieving a 100% success rate in imaging the transplanted gliomas, demonstrating its utility in monitoring tumor development in this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transplantation and magnetic resonance imaging of transplantable human glioma tissue in the brain of nude mice]. Li, RJ., Diao, Y., Huang, Q., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The study demonstrates that autografting a greater omental fragment to the brain can establish functional blood vessels within 24 hours, indicating rapid integration with the brain's vascular system.

This method shows promise for clinical use in treating cerebral circulatory disorders caused by tumors and vascular abnormalities, potentially improving outcomes for patients with these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Microsurgical revascularization of the brain with an autograft of the greater omentum (experimental research)]. Tigliev, GS., Mozhaev, SV., Kharitonov, VV., et al.[2007]

The omental fat-augmented free flap technique offers a successful autologous breast reconstruction option for women with inadequate donor sites and who prefer not to use implants, as demonstrated in three patients with no postoperative complications.

This method resulted in stable breast volume and a soft texture at 6 months post-surgery, indicating its efficacy and safety as a viable alternative to traditional reconstruction methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a Biological Breast Implant with an Omental Fat-Augmented Free Flap. Nguyen, DH., Ma, IT., Choi, YK., et al.[2022]

Patient-derived glioblastoma organoids (GBOs) effectively mimic the heterogeneity of parental tumors, which is crucial for understanding tumor behavior and treatment responses.

The study utilized GBOs to test chimeric antigen receptor (CAR)-T cell immunotherapy and established a biobank for rapid initiation of post-operative therapies, highlighting their potential in personalized cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organoids: A Platform Ready for Glioblastoma Precision Medicine? Jin, WL., Jin, MZ., Tu, YY.[2021]

A new coculture system was developed using normal rat brain fragments and glioma cell spheroids, allowing researchers to study the interaction between healthy brain tissue and tumor cells over a 30-day period.

The model demonstrated that glioma cells can invade and replace normal brain tissue, mimicking the behavior of brain tumors in living organisms, which could help in understanding tumor biology and testing potential treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction between rat glioma cells and normal rat brain tissue in organ culture. Steinsvåg, SK., Laerum, OD., Bjerkvig, R.[2006]

In a study of 13 patients undergoing craniofacial or cranial base reconstruction, laparoscopically harvested omentum free flaps showed a high survival rate of 92%, with only one flap failure due to infection, indicating its efficacy in complex reconstructions.

The use of omentum flaps resulted in satisfactory aesthetic and functional outcomes for all patients, with no perioperative or intra-abdominal complications, highlighting its safety as a reconstructive option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Laparoscopically Harvested Omental Free Flap: A Compelling Option for Craniofacial and Cranial Base Reconstruction. Costantino, PD., Shamouelian, D., Tham, T., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic omental-cerebellar pedicled graft harvest. Frantzides, CT., Madan, AK., Ferguson, RL., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05979064

Study Details | NCT05979064 | Omental Tissue Autograft in ... The laparoscopically harvested omental graft omentum would easily conform to many resected GBM cavities in our human patients with acceptable risk. The ...

2. trials.braintumor.org trials.braintumor.org/trials/NCT05979064

Omental Tissue Autograft in Human Recurrent Glioblastoma ... This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04222309

Laparoscopically Harvested Omental Free Tissue Autograft ... 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 ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/416095

Omental Tissue Autograft in Human Recurrent ... This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted ...

5. withpower.com withpower.com/trial/phase-glioblastoma-3-2023-48be8

Omental Tissue Autograft for Brain Tumor Trial Overview The study tests the safety of implanting laparoscopically harvested autologous omentum tissue into the cavity after GBM tumor resection. It's ...

6. researchgate.net researchgate.net/publication/395474727_PRELIMINARY_SAFETY_AND_EFFICACY_ASSESSMENT_OF_LAPAROSCOPICALLY_HARVESTED_AUTOLOGOUS_OMENTUM_IMPLANTS_IN_RECURRENT_GLIOBLASTOMA

PRELIMINARY SAFETY AND EFFICACY ASSESSMENT ... Autologous abdominal omental tissue was harvested laparoscopically on its vascularized pedicle in 2 patients, transposed as a free flap, ...