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

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 4 7 8}

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

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

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

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+

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.

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) 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) 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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2009]

3. United States 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. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The versatility of the temporoparietal fascia flap in head and neck reconstruction. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Technique of temporoparietal fascia flap in ear and lateral skull base surgery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Hair-bearing temporoparietal fascial flap reconstruction of upper lip and scalp defects. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Implications of Free Temporoparietal Fascial Flap Reconstruction in the Pediatric Population. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Temporoparietal Fascial Free Flap: A Systematic Review. [2023]