A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.
• There is pathological evidence of GBM using World Health Organization (WHO) classification.
• Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
• Subject must have at least one measurable lesion per RANO.
• Subject is at least 18 years of age.
• Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
• Subject has life expectancy \> 3 months.
• Subject has adequate organ and marrow function; see note 1.
• Subject able to start treatment at least 28 days from tumor resection surgery.
• Subject has provided signed informed consent.