This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Nativis Voyager Radiofrequency Energy Therapy
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Center for Neurosciences
Tucson, Arizona, United States
cCARE - California Cancer Associates for Research & Excellence
Number of any adverse events associated with the investigational therapy.
Safety Assessment as assessed by adverse events
Time frame: Through one month following investigational treatment
Clinical Utility: PFS
Progression Free Survival as assessed by RANO
Time frame: Six months
Clinical Utility: OS
Overall Survival
Time frame: 18 months
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Encinitas, California, United States
John Wayne Cancer Institute @ Providecne St. Johns Health Center
Santa Monica, California, United States
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
Providence Brain & Spine Institute
Portland, Oregon, United States
Cancer Care Collaborative
Austin, Texas, United States
Baylor Scott & White Health
Temple, Texas, United States
...and 3 more locations