ABSTRACT
AIM: Evaluation of the Nativis Voyager®, an investigational medical device, as monotherapy for recurrent glioblastoma (rGBM). MATERIALS & METHODS: A total of 15 patients with rGBM were treated with one of two Voyager ultra-low radio frequency energy cognates: A1A or A2HU. Safety and clinical utility were assessed every 2-4 months. RESULTS: Median overall survival was 8.04 months in the A1A arm and 6.89 months in the A2HU arm. No serious adverse events associated with Voyager were reported. No clinically relevant trends were noted in clinical laboratory parameters or physical exams. CONCLUSION: The data suggest that the Voyager is safe and feasible for the treatment of rGBM.
Subject(s)
Brain Neoplasms/therapy , Glioblastoma/therapy , Magnetic Field Therapy , Neoplasm Recurrence, Local/therapy , Adult , Aged , Australia , Brain Neoplasms/diagnostic imaging , Brain Neoplasms/mortality , Feasibility Studies , Female , Glioblastoma/diagnostic imaging , Glioblastoma/mortality , Humans , Magnetic Field Therapy/instrumentation , Male , Middle Aged , Neoplasm Recurrence, Local/diagnostic imaging , Neoplasm Recurrence, Local/mortality , Treatment OutcomeABSTRACT
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.
