RecruitingNot ApplicableNCT05954858

Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

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


Sponsor

Northwell Health

Enrollment

32 participants

Start Date

Jun 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical approach in patients with glioblastoma (an aggressive brain tumor) that involves placing a specialized tissue flap during surgery to help chemotherapy bypass the blood-brain barrier — the natural shield around the brain that often blocks cancer drugs from reaching tumors effectively. **You may be eligible if...** - You are 18 or older and are scheduled for surgery to remove a known or suspected glioblastoma - Your tumor can likely be removed by at least 80% - Your overall performance level (Karnofsky score ≥70%) and organ function are adequate - Your expected survival is at least 6 months **You may NOT be eligible if...** - You have already started chemotherapy or radiation for glioblastoma - You are planning to use a specific biodegradable chemotherapy wafer (Gliadel) during surgery - You have an active infection - You have cancer that has spread to multiple sites in the brain or spinal fluid - You have had another cancer and are not cancer-free for at least 5 years (with some exceptions) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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


Locations(1)

Lenox Hill Brain Tumor Center

New York, New York, United States

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NCT05954858


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