Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM

NCT03630289 | Completed

• 1 other identifier: 18-0498
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses the safety of using tissue autograft of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients. The objective of the study is to demonstrate that this surgical technique is safe in a small human cohort of patients with resected newly diagnosed GBM and may improve progression-free survival (PFS).

Conditions

Glioblastoma; Glioblastoma Multiforme; GBM; Brain Cancer

Keywords

tissue autograft; blood brain barrier

Outcome Measures

Primary Outcomes (2)

• Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria

  Increase in tumor size relative to baseline will be measured using RANO and assessed by MRI throughout study at 24 hours, 7 days, 30 days, 60 days, 90 days, 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.

  Study Day 1-180

• Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection

  Increase in seizures (defined as 15% relative to baseline), occurrence of a stroke, or occurrence of a severe infection will be determined throughout study at 24 hours, 7 days, 30 days, 60 days, 90 days, 180 days.

  Study Day 1-180

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  6 months

• Overall Survival (OS)

  2 years

Study Arms (1)

Surgical tissue autograft: TPF flap/pericranial flap

EXPERIMENTAL

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

Procedure: Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)

Interventions

Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB) PROCEDURE

Surgical tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.

Also known as: surgical tissue flap, tissue autograft

Surgical tissue autograft: TPF flap/pericranial flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a male or female 18 years of age or older.
• Subject is undergoing planned resection of known or suspected GBM.
• Subject has a Karnofsky Performance Status (KPS) 70% or greater.
• Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
• Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
• Subject must be able to undergo MRI evaluation.
• Subject meets the following laboratory criteria:
• White blood count ≥ 3,000/µL
• Absolute neutrophil count ≥ 1,500/µL
• Platelets ≥ 100,000/µL
• Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed)
• Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN
• Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
• Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.

You may not qualify if:

• Subject, if female, is pregnant or is breast feeding.
• Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.
• Subject intends to participate in another clinical trial.
• Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
• Subject has an active infection requiring treatment.
• Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
• Subject has a history of other malignancy, unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment.
• Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
• Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Brain Tumor Center

New York, New York, 10075, United States

Location

Related Publications (1)

• Doron O, Wong T, Ablyazova F, Singha S, Cavallaro J, Ben-Shalom N, D'Amico RS, Harshan M, McKeown A, Zlochower A, Langer DJ, Boockvar JA. Results from a first-in-human phase I safety trial to evaluate the use of a vascularized pericranial/temporoparietal fascial flap to line the resection cavity following resection of newly diagnosed glioblastoma. J Neurooncol. 2024 Jun;168(2):225-235. doi: 10.1007/s11060-024-04647-w. Epub 2024 Apr 26.

  PMID: 38664311 DERIVED

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John Boockvar, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 14, 2018
• Study Start: July 27, 2018
• Primary Completion: May 15, 2023
• Study Completion: March 26, 2024
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)