An early feasibility study of the Nativis Voyager® device in patients with recurrent glioblastoma: first cohort in US
Charles Cobbs,
Edward McClay,
J Paul Duic,
L Burt Nabors,
Donna Morgan Murray,
Santosh Kesari
Affiliations
Charles Cobbs
1Ben and Catherine Ivy Center for Advanced Brain Tumor Treatment, Swedish Medical Center, Seattle, WA 98122, USA
Edward McClay
2Melanoma Research Center, California Cancer Associates for Research & Excellence (cCARE), San Marcos, CA 92024, USA
J Paul Duic
3Department of Neuro-oncology, New York University, Winthrop, Mineola, NY 11501, USA
L Burt Nabors
4Division of Neuro-oncology, University of Alabama, Birmingham, AL 35294, USA
Donna Morgan Murray
5Nativis, Inc., Seattle, WA 98109, USA
Santosh Kesari
6Department of Translational Neuro-Oncology and Neurotherapeutics, John Wayne Cancer Institute & Pacific Neuroscience Institute, Santa Monica, CA 90404, USA
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 (ulRFE®) 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
