Low-dose Intra-arterial Bevacizumab for Edema and Radiation Necrosis Therapeutic Intervention (LIBERTI)

NCT02819479 ↗

Phase 2 Completed 10 enrolled Norton Healthcare University of Kentucky · collab

NaSingle-groupOpen-labelTreatment

Summary

To assess the overall safety and efficacy of intra-arterial (IA) bevacizumab for the treatment of radiation necrosis. A single 2.5 mg/kg dose of bevacizumab will be given intra-arterially after osmotic blood-brain-barrier disruption.

Timeline

Start: 2016-11-23
Primary completion: 2019-06-06
Completion: 2019-06-06

Outcome

Mixed primary results

paper RN volume decreased by 74% (median [range] 76% [53%-96%], p = 0.012) PMID 35426830 ↗

paper edema volume decreased by 50% (median [range] 70% [-11% to 83%], p = 0.086) PMID 35426830 ↗

Publications

Results Dashti SR, Kadner RJ, Folley BS, Sheehan JP, Han DY, Kryscio RJ, Carter MB, Shields LBE, Plato BM, La Rocca RV, Spalding AC, Yao TL, Fraser JF. Single low-dose targeted bevacizumab infusion in adult patients with steroid-refractory radiation necrosis of the brain: a phase II open-label prospective clinical trial. J Neurosurg. 2022 Apr 15;137(6):1676-1686. doi: 10.3171/2022.2.JNS212006. Print 2022 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	2.5 mg/kg	Other
Background	Mannitol	Diagnostic / imaging agent	25 %	Other