Results from a first-in-human phase i safety trial to evaluate the use of a vascularized pericranial/temporoparietal fascial flap to line the resection cavity following resection of newly diagnosed glioblastoma

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Summary of Clinical Trial Findings

Purpose

• Glioblastoma (GBM) treatment limitations due to systemic toxicity and blood-brain barrier (BBB) permeability
• Use of vascularized flaps to bypass BBB and improve access of immune cells to tumor microenvironment

Methods

• 12 patients with newly diagnosed GBM underwent surgical resection followed by lining of the cavity with autologous TPFF or PCF
• Safety and efficacy assessed through monitoring adverse events, progression-free disease (PFS), and overall survival (OS)

Results

• Median age of patients: 57 years
• All patients were Isocitrate dehydrogenase (IDH) wildtype
• 70% of patients had 6-month PFS
• Median PFS: 9.10 months; OS: 17.6 months
• 33% of patients have been alive for more than two years

Conclusions

• Insertion of autologous TPFF/PCF along GBM resection cavity is safe and feasible
• Encouraging response rate warrants larger phase II studies to assess safety, feasibility, and efficacy

Trial Registration

• ClinicalTrials.gov ID NCT03630289, dated: 08/02/2018

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Full Clinical Trial Report Results from a first-in-human phase i safety trial to evaluate the use of a vascularized pericranial/temporoparietal fascial flap to line the resection cavity following resection of newly diagnosed glioblastoma: https://pubmed.ncbi.nlm.nih.gov/38664311/?utm_source=Feedly&utm_medium=rss&utm_campaign=None&utm_content=1B1L42DK3a-JWCV4P_PtHHBmWjwBLFNcDXsYJkbqjQD0Ca7UQh&fc=None&ff=20240426043029&v=2.18.0.post9+e462414