Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients

Neoplasms Clinical Trial

Official title: An Open Label, Prospective, Pilot Study to Evaluate the Efficacy and Safety of Best Physician's Choice of Standard of Care Combined With NaviFUS System in Patients With Recurrent Glioblastoma Multiforme

Status Completed

Clinical Trial Summary

This is a prospective, single-arm, two stages, open-label, pilot study to investigate the efficacy and safety of FUS add-on bevacizumab (BEV) in rGBM patients. The BEV is the best physician's choice of standard of care for rGBM after prior radiotherapy and temozolomide chemotherapy in the LinKou Chang Gung Memorial Hospital. Eligible patients will be enrolled through the process of informed consent.

Clinical Trial Description

This trial will be divided into two stages. The study design and procedures will be as follows:

Stage 1:

Eligible patients will first be administered with BEV 10 mg/kg intravenous (IV) infusion. After 30-60 minutes, patients will receive microbubbles (MB) (SonoVue®) 0.1 mL/kg and optimal ultrasound exposure doses (based on the acoustic emission feedback FUS power control algorithm) generated from the NaviFUS System single exposure unit for up to two minutes every 2 weeks to transiently open the BBB.

After 4 weeks of treatment with BEV and single unit FUS-MB treatment, if the patient experienced BBB opening using FUS treatment and BEV IV infusion without any serious adverse effects (such as brain significant bleeding), then the patient may proceed to stage 2.

Stage 2:

Patients who complete stage 1 will enter stage 2 to receive the BEV with MB-mediated multiple units of FUS treatment for up to five minutes (but the maximum exposure time per single unit is two minutes) every 2 weeks for up to 30 weeks or until evidence of progressive disease, unacceptable toxicity, non-compliance with study follow-up, or withdrawal of consent.

After completion of study treatment, patients will be followed up for 28 days. ;

Related Conditions & MeSH terms

• Brain Tumor
• Glioblastoma
• Glioblastoma Multiforme
• Glioma
• Neoplasms
• Neoplasms, Nerve Tissue

• NCT number: NCT04446416
• Study type: Interventional
• Source: NaviFUS Corporation
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Completion date: August 4, 2023