Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT05954858
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Jun 29, 2023
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lenox Hill Brain Tumor CenterNew YorkNew York10075
John Boockvar, MD
[email protected]
212-434-3900
Tamika Wong, MPH
[email protected]
212-434-4836
David Langer, MD (SUB_INVESTIGATOR)
Netanel Ben-Shalom, MD (SUB_INVESTIGATOR)
Randy D'Amico, MD (SUB_INVESTIGATOR)
Deborah Gruber, MD (SUB_INVESTIGATOR)
Avraham Zlochower, MD (SUB_INVESTIGATOR)
Vadim Zhigin, PA (SUB_INVESTIGATOR)
Olivia Albers, NP (SUB_INVESTIGATOR)
Amy McKewon, NP (SUB_INVESTIGATOR)
Tamika Wong, MPH (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Lenox Hill Brain Tumor Center· New York, NY

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