Surgical Tissue Flap for Glioblastoma
Recruiting in Palo Alto (17 mi)
Overseen ByJohn Boockvar, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwell Health
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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).
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.
13578Is 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.
12356What 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.
13456Will 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.
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.Participant Groups
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.
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
Research locations nearbySelect from list below to view details:
Lenox Hill Brain Tumor CenterNew York, NY
Loading ...
Who is running the clinical trial?
Northwell HealthLead Sponsor
References
Resurfacing extensive malar and preauricular cutaneous defects with pedicled temporoparietal fascia. [2022]The pedicled temporoparietal fascial flap (TPFF) is useful for preparing extensive cutaneous facial defects for skin grafting.
Hair-bearing temporoparietal fascial flap reconstruction of upper lip and scalp defects. [2019]The temporoparietal fascial flap has proven to be a versatile flap for a broad spectrum of reconstructive problems in the head and neck. The temporoparietal fascial flap is a thin, pliable layer of richly vascularized tissue that may be transferred either pedicled or free and alone or as a carrier of subjacent bone or overlying skin and scalp.
Vascularized temporoparietal fascial flap for the treatment of a traumatic cerebrospinal fluid fistula in the middle cranial fossa. Technical note. [2009]The temporoparietal fascial flap (TPFF) is a vascularized pedicle flap commonly used in head and neck reconstructions. The authors describe the use of a TPFF in repairing a large traumatic middle cranial fossa CSF fistula via a middle cranial fossa approach. During the 18-month follow-up, the patient had no further CSF leakage or meningitis. The use of a TPFF for the repair of a traumatic CSF fistula has not been described in the literature. The authors recommend the use of a TPFF in treating recurrent or large middle cranial fossa CSF fistulas. The flap provides a well-vascularized thin layer that can be ideal in middle cranial fossa repair, and its proximity to the operation site is perfect as well.
Technique of temporoparietal fascia flap in ear and lateral skull base surgery. [2022]The temporoparietal fascia (TPF) is a distinct anatomic layer of the lateral scalp with a defined blood supply. The TPF flap has desirable properties for otologic surgery: high malleability, distinct vascularity, and close proximity to the temporal bone. This article describes our technique for preserving the TPF in approaches to the temporal bone and its subsequent use in otologic reconstructive surgery.
The versatility of the temporoparietal fascia flap in head and neck reconstruction. [2022]The temporoparietal fascia flap (TPFF) is a versatile tool in head and neck reconstruction. This article aims to describe the spectrum of TPFF applications through a series of case studies and related review of the literature.
Lessons Learned from the Initial Experience with Pedicled Temporoparietal Fascial Flap for Combined Revascularization In Moyamoya Angiopathy: A Case Series. [2020]The pedicled temporoparietal fascial flap (TPFF) with a direct superficial temporal (STA) artery to middle cerebral artery (MCA) bypass is a novel combined revascularization approach for moyamoya angiopathy (MMA). With this case series, we aim to report the initial experience with pedicled TPFF combined revascularization for MMA treatment.
Implications of Free Temporoparietal Fascial Flap Reconstruction in the Pediatric Population. [2022]The temporoparietal fascial flap (TPFF) is a versatile tool that can be used in the reconstruction of head and neck and distal upper and lower extremity defects. The TPFF may be harvested as a pedicle or free flap as well as with the temporalis muscle and/or adjacent calvarial bone as a composite flap. As a free flap, the TPFF has been used as a joint gliding surface with coverage of nerves and tendons, for extremity soft tissue repair, for tracheal and pharyngeal coverage and for defects of the nose, scalp, and auricle. This article focuses on the use of the free TPFF in the pediatric population through systemic review of the medical literature. Current perspectives on the use of this flap and microsurgery in general in pediatric patients are addressed.
Temporoparietal Fascial Free Flap: A Systematic Review. [2023]The temporoparietal fascial flap (TPFF) is a versatile tool used in head and neck reconstructive surgeries as well as distal upper and lower extremity reconstructions. Depending on the anatomical location and characteristics of the recipient site soft tissue defects, harvesting techniques for TPFF retrieval may include elevation as a pedicle or a free flap, inclusion of the temporalis muscle and/or adjacent calvarial bone as a composite flap. The TPFF as a free flap is not only used for soft tissue coverage of various defects, and it can be used as a joint gliding surface with coverage of nerve and tendons after repair or trauma. This article includes a systematic search of the medical literature for indications, historical background, techniques, current perspective, and complications along with the pros and cons of the free TPFF compared with other potential reconstructive options.