Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry

Author:

Lillehei Kevin O1,Kalkanis Steven N2,Liau Linda M3,Mydland Dellann Elliott4,Olson Jeffrey5,Paleologos Nina A6,Ryken Timothy7,Johnson Tania8,Scullin Evan8

Affiliation:

1. Department of Neurosurgery, University of Colorado School of Medicine, Denver, CO, 80045, USA

2. Department of Neurosurgery, Henry Ford Hospital, Detroit, MI, 48202, USA

3. Department of Neurosurgery, David Geffen School of Medicine, UCLA, Los Angeles, 90095, CA, USA

4. EndBrainCancer Initiative, Redmond, WA, 98052, USA

5. Department of Neurosurgery, Emory University, Atlanta, GA, 30322, USA

6. Department of Neurology, Advocate Healthcare, Chicago, IL, 60515, USA

7. Department of Neurosurgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, 03756, USA

8. Arbor Pharmaceuticals, LLC, Atlanta, GA, 30328, USA

Abstract

Implantation of biodegradable wafers impregnated with carmustine (BCNU) is one of the few chemotherapeutic modalities that have been evaluated in Phase III trials and approved by the US FDA for treatment of newly diagnosed high-grade glioma and recurrent glioblastoma. Enrolling up to 500 patients for 3-year follow-up at over 30 sites, the prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) registry (NCT02684838) will evaluate BCNU wafers for treatment of CNS malignancies in contemporary practice and in the new era of molecular tumor analysis. Subgroup analyses will include tumor type, molecular marker status, and treatment combinations. Interim analyses from the VIGILANT registry will be reported until complete results are available in 2024.

Publisher

Future Medicine Ltd

Subject

General Medicine

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