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

Authors

Garni Barkhoudarian, Saint John's Cancer Institute & Pacific Neuroscience Institute at Providence St. John's Health Center, Santa Monica, CA 90404, USA.Follow
Michael Badruddoja
Nicholas Blondin
Sajeel Chowdhary
Charles Cobbs, Swedish Medical Center, Ben and Catherine Ivy Center For Advanced Brain Tumor Treatment, Seattle, WA 98122, USA.Follow
Julius Paul Duic
John Paul Flores
Ekokobe Fonkem
Edward McClay
Louis Burt Nabors
Michael Salacz
Lynn Taylor
Brian Vaillant
Jaya Gill, Saint John's Cancer Institute & Pacific Neuroscience Institute at Providence St. John's Health Center, Santa Monica, CA 90404, USA.Follow
Santosh Kesari, Saint John's Cancer Institute & Pacific Neuroscience Institute at Providence St. John's Health Center, Santa Monica, CA 90404, USA.Follow

Document Type

Article

Publication Date

9-1-2023

Publication Title

CNS Oncol

Keywords

santa monica; california; swedish; washington

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).

Clinical Institute

Cancer

Department

Oncology

Recommended Citation

Barkhoudarian, Garni; Badruddoja, Michael; Blondin, Nicholas; Chowdhary, Sajeel; Cobbs, Charles; Duic, Julius Paul; Flores, John Paul; Fonkem, Ekokobe; McClay, Edward; Nabors, Louis Burt; Salacz, Michael; Taylor, Lynn; Vaillant, Brian; Gill, Jaya; and Kesari, Santosh, "An expanded safety/feasibility study of the EMulate Therapeutics Voyager™ System in patients with recurrent glioblastoma." (2023). Articles, Abstracts, and Reports. 7775.
https://digitalcommons.providence.org/publications/7775