32 Participants Needed

Surgical Tissue Flap for Glioblastoma

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)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Surgical Tissue Flap for Glioblastoma?

The temporoparietal fascial flap (TPFF) has been effectively used in head and neck reconstructions, such as repairing cerebrospinal fluid leaks and reconstructing facial defects, due to its good blood supply and proximity to the surgical site. These properties suggest it could be beneficial in glioblastoma surgery by providing well-vascularized tissue to support healing.12345

Is the surgical tissue flap treatment generally safe for humans?

The surgical tissue flap, known as the temporoparietal fascial flap (TPFF), has been used safely in various head and neck reconstructions, including repairing facial defects and cerebrospinal fluid leaks, with no reported complications in the studies reviewed.12346

How is the surgical tissue flap treatment for glioblastoma different from other treatments?

The surgical tissue flap treatment for glioblastoma is unique because it uses a patient's own tissue (autograft) from the temporoparietal fascial or pericranial area to repair and reconstruct areas affected by the tumor. This approach is different from standard treatments like chemotherapy or radiation, as it focuses on physical reconstruction and healing using the body's own tissues, which can provide a well-vascularized (good blood supply) and thin layer ideal for repair.12478

What is the purpose of this trial?

This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.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 diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).

Research Team

JB

John Boockvar, MD

Principal Investigator

Feinstein Institute for Medical Research/Lenox Hill Hospital

Eligibility Criteria

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.
See 4 more

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
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Surgical tissue autograft: TPF flap/pericranial flapExperimental Treatment1 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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Findings from Research

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

References

Resurfacing extensive malar and preauricular cutaneous defects with pedicled temporoparietal fascia. [2022]
Vascularized temporoparietal fascial flap for the treatment of a traumatic cerebrospinal fluid fistula in the middle cranial fossa. Technical note. [2009]
Lessons Learned from the Initial Experience with Pedicled Temporoparietal Fascial Flap for Combined Revascularization In Moyamoya Angiopathy: A Case Series. [2020]
The versatility of the temporoparietal fascia flap in head and neck reconstruction. [2022]
Technique of temporoparietal fascia flap in ear and lateral skull base surgery. [2022]
Hair-bearing temporoparietal fascial flap reconstruction of upper lip and scalp defects. [2019]
Implications of Free Temporoparietal Fascial Flap Reconstruction in the Pediatric Population. [2022]
Temporoparietal Fascial Free Flap: A Systematic Review. [2023]
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