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An early feasibility study of the Nativis Voyager® device in patients with recurrent glioblastoma: first cohort in US.

Al's Comment:

Voyager is an experimental  device that is worn on the head and is used to treat the brain tumor.  This small study shows that the device is safe, but we can't tell if it helps yet.  They have a very impressive list of authors on the paper, so I know the research will be done correctly.


Posted on: 12/15/2018

  CNS Oncol. 2018 Dec 14:CNS. doi: 10.2217/cns-2018-0013. [Epub ahead of print]
An early feasibility study of the Nativis Voyager® device in patients with recurrent glioblastoma: first cohort in US.
Cobbs C1, McClay E2, Duic JP3, Nabors LB4, Morgan Murray D5, Kesari S6.
 
Author information:
1. Ben and Catherine Ivy Center for Advanced Brain Tumor Treatment, Swedish Medical Center, Seattle, WA 98122, USA.
2. Melanoma Research Center, California Cancer Associates for Research & Excellence (cCARE), San Marcos, CA 92024, USA.
3. Department of Neuro-oncology, New York University, Winthrop, Mineola, NY 11501, USA.
4. Division of Neuro-oncology, University of Alabama, Birmingham, AL 35294, USA.
5. Nativis, Inc., Seattle, WA 98109, USA.
6. Department of Translational Neuro-Oncology and Neurotherapeutics, John Wayne Cancer Institute & Pacific Neuroscience Institute, Santa Monica, CA 90404, USA.
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 (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.
PMID: 30547676 

 


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