Actr-26. a Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma (gbm)
Year: 2018
Type: article
Study design: Clinical Trial
Abstract: The Nativis Voyager® system is a non-sterile, non-invasive, non-thermal, portable, investigational medical device that uses a specific, localized ultra-low radio frequency energy (ulRFE®) cognate for the treatment of brain cancer. In this prospective, open-label, multi-center trial, adults newly diagnosed with GBM, following maximal tumor debulking, are eligible for enrollment. The objective of the study is to assess if the Voyager ulRFE therapy is a safe and feasible treatment for newly diagnosed GBM when combined with standard of care (i.e., focal radiotherapy + temozolomide). Patients receive continual therapy with the Voyager, concurrently with radiotherapy + temozolomide. Upon progression, investigators can choose to maintain patients on study with the Voyager and to add second-line therapy. The primary outcome measure is safety, which is assessed by the incidence and evaluation of any adverse events associated with the Voyager through follow-up. The secondary outcome measure is clinical utility, which is assessed by progression-free survival and overall survival. Eleven patients were enrolled at 3 centers into the first (safety) cohort of this study. No device-related adverse events were reported by patients receiving concurrent therapy with Voyager + radiotherapy + temozolomide. All patients remain progression-free and on study as of June 2018. Given the safety profile, enrollment was expanded to 32 patients. Additional interim safety and clinical utility data will be reported. The Nativis Voyager system appears to be safe and feasible for the treatment of GBM. Given that therapy is delivered non-invasively and no device-related adverse events were reported, further prospective study of the investigational device is warranted.
Source: Neuro-Oncology
Institution: St. Vincent's Medical Center
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2900323691