An early feasibility study of the Nativis Voyager® device in patients with recurrent glioblastoma: first cohort in US. (14th December 2018)

• Record Type: Journal Article
• Authors: Cobbs, Charles; McClay, Edward; Duic, J Paul; Nabors, L Burt; Morgan Murray, Donna; Kesari, Santosh
• Is Part Of: CNS oncology. Volume 8:Number 1(2019)
• Publication Date: 2018-12-14
• Subjects: brain tumor -- clinical trials -- Glioblastoma multiforme -- medical device -- novel therapy -- recurrent GBM -- ultra-low radiofrequency energy; Central nervous system -- Tumors -- Periodicals; 616.99481
• DOI: 10.2217/cns-2018-0013
• Languages: English
• ISSNs: 2045-0907

Abstract

Aim: Evaluation of the Nativis Voyager ® device in patients with recurrent glioblastoma (rGBM).Materials & methods: Voyager is a noninvasive, nonthermal, nonionizing and portable investigational device which delivers ultra-low radio frequency energy ( ul RFE ® ) that uses a magnetic field to penetrate tissues to alter specific biologic functions within cells. Patients with rGBM were treated with Voyager alone (V) or Voyager in combination with standard of care (V + SoC). Safety and clinical utility were assessed every 2–4 months.Results: Data from the first 11 patients treated are reported here. Median progression-free survival was 10 weeks in the V arm and 16 weeks in the V + SoC arm. Median overall survival was 16 months in V arm and 11 months in the V + SoC arm. No serious adverse events associated with the device were reported.Conclusion: These data suggest that the Voyager is safe and feasible for the treatment of rGBM