Surgical Tissue Flap for Glioblastoma

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)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 73

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical technique for individuals with newly diagnosed glioblastoma, a type of brain cancer. Researchers aim to determine if placing a small piece of tissue, using a method called a "flap," into the area where the tumor was removed can enhance treatment safety and extend the time patients live without cancer recurrence. This involves a tissue autograft of a pedicled temporoparietal fascial (TPF) or pericranial flap. It is intended for those planning surgery to remove most of their glioblastoma and who have not yet started other treatments like chemotherapy or radiation. As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical advancements that could improve future glioblastoma treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have started chemotherapy or radiation for GBM, you cannot participate in this trial.

What prior data suggests that this surgical technique is safe for glioblastoma patients?

A previous study found that using a piece of a patient's own tissue, called a pedicled temporoparietal fascial (TPF) or pericranial flap, is safe and feasible. This tissue is placed where a brain tumor, known as glioblastoma, was removed. Reports from the study did not highlight any major safety issues, suggesting that patients generally tolerated the procedure well. While the study aims to demonstrate that this method is safe and can help patients live longer, the initial findings are positive regarding safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for glioblastoma, like surgery, radiation, and chemotherapy, aim to remove or kill cancer cells. However, the surgical tissue flap technique is unique because it involves using a patient's own tissue, specifically the temporoparietal fascial (TPF) flap or pericranial flap, to reconstruct the cavity left after tumor removal. This approach may help protect the brain and support healing, potentially leading to better outcomes. Researchers are excited because this technique could offer a new way to improve recovery and enhance the quality of life for patients with glioblastoma.

What evidence suggests that this surgical technique is effective for glioblastoma?

Research has shown that using a patient's own tissue, such as a flap from the scalp or forehead, might help treat glioblastoma, a type of brain cancer. In this trial, participants will receive a surgical tissue autograft using either a temporoparietal fascial (TPF) flap or a pericranial flap placed into the resection cavity. Early studies found that placing this tissue where the tumor was removed is safe and feasible. This approach aims to extend the time patients live without cancer progression and to increase overall lifespan. The goal is to protect healthy brain tissue and possibly slow the tumor's return. While more research is needed, these early results are encouraging. ^{1 2 3 4 5}

Who Is on the Research Team?

John Boockvar, MD

Principal Investigator

Feinstein Institute for Medical Research/Lenox Hill Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of Grade IV glioblastoma multiforme (GBM) who are candidates for significant tumor resection and have not started chemotherapy or radiation. They must be in good enough health to expect to live at least six more months, able to undergo MRI scans, and meet specific blood test criteria. Women of childbearing age must test negative for pregnancy and agree to birth control; men must also agree to use contraception.

Inclusion Criteria

I am able to care for myself but may not be able to do active work.

I am scheduled for surgery to remove a brain tumor suspected to be GBM.

My neurosurgeon believes they can remove at least 80% of my tumor.

Exclusion Criteria

I don't have any health conditions that could risk my safety or affect the study.

I am currently being treated for an infection.

Subject intends to participate in another clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo standard surgical resection for newly diagnosed GBM followed by the implantation of a TPF or pericranial flap into the resection cavity

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for side effects and progression-free survival at specified intervals

6 months

Visits at 72 hours, 7 days, 30 days, 60 days, 120 days, and 180 days (in-person)

Long-term Follow-up

Participants are monitored for overall survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap

Trial Overview The study is testing the safety and effectiveness of using a patient's own tissue flap—either temporoparietal fascial (TPF) or pericranial—to bypass the blood-brain barrier after surgical removal of GBM tumors. The goal is to see if this technique can improve survival without disease progression and overall lifespan in patients.

How Is the Trial Designed?

Group I: Surgical tissue autograft: TPF flap/pericranial flap Experimental Treatment 1 Intervention

Use of a pedicled autologous piece of tissue called the temporoparietal fascial (TPF) flap or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients

Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap is already approved in United States for the following indications:

Approved in United States as Pedicled Temporoparietal Fascial Flap for:

• Glioblastoma Multiforme (GBM)
• Anaplastic Astrocytoma (AA)

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

The temporoparietal fascial flap (TPFF) was successfully used to repair a large traumatic CSF fistula in the middle cranial fossa, with no recurrence of CSF leakage or meningitis observed during an 18-month follow-up.

This study suggests that the TPFF is an effective option for repairing recurrent or large CSF fistulas due to its well-vascularized structure and close proximity to the surgical site, which enhances the repair process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascularized temporoparietal fascial flap for the treatment of a traumatic cerebrospinal fluid fistula in the middle cranial fossa. Technical note. Taha, M., Carroll, T., McMahon, J.[2009]

The pedicled temporoparietal fascial flap (TPFF) effectively supports skin grafting for extensive facial defects, as demonstrated in two patient cases where it provided a successful vascularized tissue bed leading to complete graft survival.

Using the TPFF not only simplified the reconstruction process but also helped restore lost volume and improve facial contours, potentially reducing the need for more complex surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resurfacing extensive malar and preauricular cutaneous defects with pedicled temporoparietal fascia. Dolan, R.[2022]

The temporoparietal fascial flap (TPFF) is a highly adaptable option for reconstructive surgeries in the head and neck, as well as for upper and lower extremities, allowing for various harvesting techniques based on the specific needs of the soft tissue defects.

As a free flap, the TPFF not only provides soft tissue coverage but also serves as a joint gliding surface, which is beneficial for protecting nerves and tendons after injuries or repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporoparietal Fascial Free Flap: A Systematic Review. Horen, SR., Hamidian Jahromi, A., Konofaos, P.[2023]

In a study involving 6 male patients, the hair-bearing temporoparietal fascial flap was successfully used to reconstruct extensive upper lip and scalp defects, achieving satisfactory cosmetic results and restoring oral function.

The flap's characteristics, including its ability to mimic the normal color, texture, and hair-bearing qualities of the face, make it an excellent option for effective and aesthetically pleasing reconstructive surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair-bearing temporoparietal fascial flap reconstruction of upper lip and scalp defects. Kim, JC., Hadlock, T., Varvares, MA., et al.[2019]

The temporoparietal fascial flap (TPFF) is a highly adaptable surgical option for reconstructing various defects in the head, neck, and extremities, demonstrating its versatility in pediatric patients.

As a free flap, the TPFF can effectively provide coverage for critical structures such as nerves and tendons, and is used in a range of applications including soft tissue repair and coverage of tracheal and pharyngeal defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of Free Temporoparietal Fascial Flap Reconstruction in the Pediatric Population. Hamidian Jahromi, A., Horen, SR., Konofaos, P.[2022]

The pedicled temporoparietal fascial flap (TPFF) combined with a direct bypass to the middle cerebral artery (MCA) shows promise as a revascularization strategy for moyamoya angiopathy, with 78.6% of patients achieving good functional outcomes after surgery.

While the technique was effective overall, it may be less optimal for high-risk patients, particularly those with acute ischemia or a modified Rankin Scale (mRS) score greater than 3, as indicated by complications and less favorable outcomes in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned from the Initial Experience with Pedicled Temporoparietal Fascial Flap for Combined Revascularization In Moyamoya Angiopathy: A Case Series. Ravina, K., Kim, PE., Rennert, RC., et al.[2020]

The temporoparietal fascia (TPF) flap is a valuable reconstructive option in otologic surgery, showing high success rates with 65 flaps performed for various conditions, primarily cholesteatoma and chronic otitis media.

Complications were low, occurring in only 5% of cases, indicating that with proper technique, the TPF flap can be safely utilized for effective ear and skull base reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique of temporoparietal fascia flap in ear and lateral skull base surgery. Stow, NW., Gordon, DH., Eisenberg, R.[2022]

The temporoparietal fascia flap (TPFF) is a highly versatile tool in head and neck reconstruction, effectively used in various applications such as auricular reconstruction and facial soft tissue augmentation, as demonstrated in seven distinct case studies.

The TPFF is characterized by its pliable, ultra-thin, yet durable and highly vascular properties, making it an essential option for reconstructive surgeons in complex head and neck surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The versatility of the temporoparietal fascia flap in head and neck reconstruction. Collar, RM., Zopf, D., Brown, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05954858

Surgical Tissue Flap to Bypass the Blood Brain Barrier in ... The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38664311/

Results from a first-in-human phase I safety trial to evaluate ... This pilot study suggests that insertion of pedicled autologous TPFF/PCF along a GBM resection cavity is safe and feasible.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11147875/

Results from a first-in-human phase I safety trial to evaluate ... We conducted a first-in-human Phase I trial assessing the safety of lining the resection cavity with autologous TPFF/PCF of newly diagnosed patients with GBM.

4. withpower.com withpower.com/trial/surgical-tissue-flap-for-glioblastoma-5d11e

Surgical Tissue Flap for Glioblastoma Trial Overview The study is testing the safety and effectiveness of using a patient's own tissue flap—either temporoparietal fascial (TPF) or pericranial—to ...

5. ctv.veeva.com ctv.veeva.com/study/surgical-tissue-flap-to-bypass-the-blood-brain-barrier-in-gbm

Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM This study assesses the safety of using tissue autograft of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection ...