Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.

⁃ Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).

• Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).

• TPFF and/or pericranial flap is technically feasible.

Locations
United States
New York
Lenox Hill Brain Tumor Center
RECRUITING
New York
Contact Information
Primary
John Boockvar, MD
jboockvar@northwell.edu
212-434-3900
Backup
Tamika Wong, MPH
twong4@northwell.edu
212-434-4836
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 32
Treatments
Experimental: Surgical tissue autograft: TPF flap/pericranial flap
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
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov

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