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Clinical Trial
. 2019 Mar;8(1):CNS30.
doi: 10.2217/cns-2018-0013. Epub 2018 Dec 14.

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

Charles Cobbs  1 , Edward McClay  2 , J Paul Duic  3 , L Burt Nabors  4 , Donna Morgan Murray  5 , Santosh Kesari  6
Affiliations
Clinical Trial

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

Charles Cobbs et al. CNS Oncol. 2019 Mar.

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.

Keywords: clinical trials; medical device; novel therapy; recurrent GBM; ultra-low radiofrequency energy; brain tumor.

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Conflict of interest statement

Financial & competing interests disclosure

This study was funded by Nativis, Inc. Portions of the data were presented at the 2017 Society for Neuro-oncology Annual Meeting in San Francisco, CA, USA. C Cobbs and S Kesari are members of the Nativis Scientific Advisory Board. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Figures

<b>Figure 1.</b>
Figure 1.. Nativis Voyager device as worn by a patient.
The Voyager headband is placed on the patient's head and connected to the controller. It is a closed-loop solenoid coil overmolded in a medical-grade silicone designed to generate a nonlinear, oscillating magnetic field. The flexible headband is available in four sizes and includes a two-conductor cable with a latching connector for the Voyager controller. The Voyager controller is clipped to the patient's pocket, belt or armband. It is a software-controlled amplifier powered by a rechargeable lithium-ion battery that delivers a cognate to the patient via the Voyager headband. The small, lightweight, device includes a single recessed power button and an LCD display that enables the user to read the device status. There is no user-programming required and there is no personal health information stored within the device.
<b>Figure 2.</b>
Figure 2.. Examples of MRI responses on study.
All patients were treated continuously with the Voyager. Investigators were given the choice to treat patients with Voyager alone or to treat with Voyager plus anticancer agents of their choice. (A) 55-year-old female with GBM at first recurrence (methylation status unknown) treated with Voyager alone arm. Serial axial and coronal T1 postgadolinium images show PR at cycle 2 and eventual progression at cycle 7. (B) 54-year-old male with GBM at second recurrence (methylation status unknown) treated with Voyager plus temozolomide. Serial axial T1 postgadolinium images show PR at cycle 3 and eventual progression at cycle 6. (C) 55-year-old male with GBM at first recurrence (methylated) treated with Voyager plus lomustine. Serial axial T1 postgadolinium images show PR at cycle 5. GBM: Glioblastoma; PR: Partial response.
<b>Figure 3.</b>
Figure 3.. The relationship between survival and tumor response in Voyager alone and Voyager + standard of care treatment arms.
All patients were treated continuously with the Voyager. Investigators were given the choice to treat patients with Voyager alone or to treat with Voyager plus anticancer agents of their choice. Tumor response was determined via MRI every 2–4 months, according to the modified RANO criteria. This modified waterfall plot illustrates the relationship overall survival (in months) and the best overall tumor response.
See this image and copyright information in PMC

Comment in

  • How far will the Voyager® take us?
    Levin VA. Levin VA. CNS Oncol. 2019 Mar;8(1):CNS26. doi: 10.2217/cns-2018-0019. Epub 2019 Feb 15. CNS Oncol. 2019. PMID: 30767555 Free PMC article. No abstract available.

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