Surgical Tissue Flap for Glioblastoma
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for side effects and progression-free survival at specified intervals
Long-term Follow-up
Participants are monitored for overall survival
Treatment Details
Interventions
- Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap
Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap is already approved in United States for the following indications:
- Glioblastoma Multiforme (GBM)
- Anaplastic Astrocytoma (AA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor