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Clinical Trial
. 2023 Sep 1;12(3):CNS102.
doi: 10.2217/cns-2022-0016. Epub 2023 Jul 18.

An expanded safety/feasibility study of the EMulate Therapeutics Voyager™ System in patients with recurrent glioblastoma

Garni Barkhoudarian  1 , Michael Badruddoja  2 , Nicholas Blondin  3 , Sajeel Chowdhary  4 , Charles Cobbs  5 , Julius Paul Duic  6 , John Paul Flores  7 , Ekokobe Fonkem  8 , Edward McClay  9 , Louis Burt Nabors  10 , Michael Salacz  11 , Lynn Taylor  12 , Brian Vaillant  13 , Jaya Gill  1 , Santosh Kesari  1
Affiliations
Clinical Trial

An expanded safety/feasibility study of the EMulate Therapeutics Voyager™ System in patients with recurrent glioblastoma

Garni Barkhoudarian et al. CNS Oncol. .

Abstract

Aim: The EMulate Therapeutics Voyager™ is a simple, wearable, home-use device that uses an alternating electromagnetic field to alter biologic signaling within cells. Objective: To assess the safety/feasibility of the Voyager in the treatment of recurrent glioblastoma (rGBM). Methods: In this study, patients with rGBM were treated with Voyager as monotherapy or in combination with standard chemotherapy at the Investigator's discretion. Safety was assessed by incidence of adverse events associated with the Voyager. Patients were followed until death. Results: A total of 75 patients were enrolled and treated for at least one day with the Voyager (safety population). Device-related adverse events were uncommon and generally did not result in interruption or withdrawal from treatment. There were no serious adverse events associated with Voyager. A total of 60 patients were treated for at least one month (clinical utility population). The median progression-free survival (PFS) was 17 weeks (4.3 months) in the Voyager only group (n = 24) and 21 weeks (5.3 months) in the Voyager + concurrent therapy group (n = 36). The median overall survival (OS) was 7 months in the Voyager only group and 9 months in the Voyager + concurrent therapy group. In patients treated with Voyager + concurrent therapy, the median OS for patients enrolled with their 1st or 2nd recurrence (n = 26) was 10 months, while in patients enrolled with their 3rd or 4th recurrence (n = 10) OS was 7 months. Conclusion: The data support the safety and feasibility of the Voyager for the treatment of rGBM. Further prospective study of the device is warranted. Trial Registration Number: NCT02296580 (ClinicalTrials.gov).

Keywords: GBM; brain tumor; clinical trial; electromagnetic field; medical device; novel therapy; recurrent glioblastoma.

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Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.. CONSORT flow diagram.
Pt: Patient; SoC: Standard of care.
Figure 2.
Figure 2.. Relationship of survival and tumor response (treated population).
Patients received continuous Voyager therapy. The protocol allowed for investigators to treat patients with Voyager alone or to treat with Voyager plus anticancer agents of their choice. Tumor response was assessed via MRI every 42 days. This modified waterfall plot illustrates the relationship between overall survival (in months) and the best overall tumor response. (A) All treated patients (n = 75). (B) Patients who entered the study with their first or second recurrence (n = 32).
See this image and copyright information in PMC

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