An interventional study of Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB) in Glioblastoma, Glioblastoma Multiforme and GBM, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Northwell Health · Not applicable, Interventional, and Treatment
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).
Glioblastoma (GBM) is the most common primary central nervous system malignancy in adults, and accounts for over half of all malignant brain tumors. The prognosis for newly diagnosed GBM is extremely poor even with Stupp protocol consisting of surgery followed by temozolomide and radiotherapy. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months and treatment for GBM remains a significant unmet clinical need in oncology.
All subjects included in the study will initially undergo standard surgical resection for newly diagnosed GBM. Following the resection, the surgical cavity will be lined with a long pedicled, autologous piece of tissue called a temporoparietal fascial flap or pericranium. The patient's dura, bone and scalp will be closed as is customary. The permeability of the blood vessels of the TPF or pericranial flap should allow for improved delivery of therapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular space and microenvironment of the resected tumor cavity including the brain adjacent to the GBM. The TPF or pericranial flap would easily conform to many resected GBM cavities in our human patients with acceptable risk. The TPF and pericranial flap with its predictable and rich vascular anatomy have been shown to be an ideal flap for cases of previously irradiated and/or infected wound beds.
The investigators hypothesize that a TPF or pericranial flap that is harvested in our patients with resected GBM may be used as a readily available and accessible means of circumventing the blood brain barrier selectively and focally. The investigators aim to prove 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).
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
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Inclusion Criteria:
Subject meets the following laboratory criteria:
Inclusion criteria considered during surgery:
Exclusion Criteria:
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)
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
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.
Time frame: 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.
Time frame: Study Day 1-180
Progression Free Survival (PFS)
The proportion of patients who are alive at 6 months from flap implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval. All patients will be followed for a minimum of six months from the time of implantation. For this analysis, patients who are lost to follow-up prior to 6 months will be (conservatively) assumed as treatment failures at 6 months. The investigators will also estimate PFS using the Kaplan-Meier Product Limit Method. For this analysis, subjects who are alive and have not progressed as of the date of last follow-up will be considered censored.
Time frame: 6 months
Overall Survival (OS)
OS will be calculated as the time from treatment initiation (TPF implantation) to the time of death. Subjects who are alive as of the date of last follow-up will be considered censored for survival. OS will be analyzed using the Kaplan-Meier Product Limit Method.
Time frame: 2 years
Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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