Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

NCT05954858 | Recruiting

• 1 other identifier: 23-0385
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Glioma, Malignant; Glioblastoma; Glioblastoma Multiforme; Glioblastoma Multiforme, Adult; High Grade Glioma; GBM; Brain Cancer

Keywords

tissue autograft; blood brain barrier; pedicled temporoparietal fascial; pericranial flap

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as time from surgery until first known disease progression or death from any cause, whichever occurs first.

  6 months

Secondary Outcomes (1)

• 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: No
• 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

RECRUITING

MeSH Terms

Conditions

Glioma; Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• John Boockvar, MD

  Feinstein Institute for Medical Research/Lenox Hill Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Boockvar, MD

CONTACT

212-434-3900; jboockvar@northwell.edu

Tamika Wong, MPH

CONTACT

212-434-4836; twong4@northwell.edu

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: July 13, 2023
• First Posted: July 20, 2023
• Study Start: June 29, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)