FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM
Summary
The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.
Detailed description
Glioblastoma (GBM) is a highly aggressive brain cancer with a grave prognosis, resulting in \<7% of patients surviving to five years post-diagnosis. External beam radiotherapy (EBRT) is currently a mainstay treatment for GBM; however, the dose delivered is limited by side effects. The targeted radiotherapy of the TheraSphere GBM Y-90 Glass Microsphere System (TheraSphere GBM) has promising potential to provide GBM patients with reduced side effects compared to external beam radiotherapy as well as a more effective treatment for this catastrophic disease. The TheraSphere GBM device utilized in the FRONTIER trial is an yttrium-90 (Y-90) glass microsphere therapy for selective internal radiation therapy (endovascular radiotherapy) in recurrent GBM patients. The TheraSphere GBM treatment utilizes intra-arterial delivery and takes advantage of blood flow and direct tumor delivery. Treatment can be delivered by specific placement of a catheter close to the tumor through known angiographic techniques currently utilized by neuro-endovascular or interventional radiology physicians. Angiographic evaluation prior to treatment allows identification of tumor feeding arteries and definition of the treatment volume. TheraSphere GBM could achieve a high tumor response rate based on delivery of a tumor absorbed dose that is not currently possible with EBRT. In consideration of the potential benefit of a more localized, targeted treatment with a reduced side effect profile compared to other treatment options, and the potential impact on patients' quality of life for this devastating disease, this First-in-Human Early Feasibility Study (EFS) of the TheraSphere GBM Y-90 Glass Microsphere System for the treatment of recurrent GBM is being conducted.
Arms & interventions
- DeviceTheraSphere GBM
Single treatment of TheraSphere GBM device
Outcome measures
Primary
The number of grade 3-5 non-hematological toxicities
Time frame: 30 days post index procedure
The number of ≥ grade 3 CNS toxicities related to non-target embolization
Time frame: 30 days post index procedure
Occurrence of symptomatic brain radiation necrosis requiring medical or surgical intervention and confirmed by pathology
Time frame: 30 days post index procedure
The number of Grade 4 neutropenia events persisting for longer than 5 days
Time frame: 30 days post index procedure
The number of grade 4 febrile neutropenia
Time frame: 30 days post index procedure
The number of grade 4 thrombocytopenia or grade 3 thrombocytopenia with hemorrhage
Time frame: 30 days post index procedure
Secondary
Rate of any treatment-related adverse events and treatment-related serious adverse events (not including predefined Limiting Toxicities) from first patient enrolled through study completion.
Time frame: Enrollment through 6 months post index procedure
Change in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS).
Time frame: Enrollment through 6 months post index procedure
Change in post-treatment neurological function as assessed by the modified Rankin Scale (mRS).
Time frame: Enrollment through 6 months post index procedure
Technical Success/Feasibility of TheraSphere GBM - ability to deliver the projected radiation absorbed dose (+/- 20%) to the perfused volume for all patients treated with the device. Assessed from pre-screening through post-device delivery PET-CT/MRI.
Time frame: Pre-screening through post-device delivery PET-CT/MRI.
Objective Response Rate* (ORR) from first patient enrolled through study completion
Time frame: Enrollment through 6 months post index procedure
Progression Free Survival* (PFS) from first patient enrolled through study completion
Time frame: Enrollment through 6 months post index procedure
Overall Survival (OS) from first patient enrolled through study completion
Time frame: Enrollment through 6 months post index procedure
Eligibility criteria
Study locations (9)
University of Alabama Birmingham
Birmingham, Alabama, 35294
University of California San Diego
San Diego, California, 92103
University of California San Francisco
San Francisco, California, 94143
Mayo Jacksonville
Jacksonville, Florida, 32224
Northwestern Univerity
Chicago, Illinois, 60611
Johns Hopkins Interventional Radiology Center
Baltimore, Maryland, 21287
Washington University School of Medicine
St Louis, Missouri, 63130
Lenox Hill Hospital
New York, New York, 10075
MD Anderson Cancer Center
Houston, Texas, 77030
References
- Meiselman S, Thomas MA, Giardina JD, Zheleznyak A, Thorek DLJ, Malone CD. Advances in Radioembolization for Liver Cancer. J Vasc Interv Radiol. 2025 Dec;36(12):1876-1881. doi: 10.1016/j.jvir.2025.07.018.(PubMed)