A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM

NCT05303467 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: S2478
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Glioblastoma Multiforme; Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (6)

• The number of grade 3-5 non-hematological toxicities

  30 days post index procedure

• The number of ≥ grade 3 CNS toxicities related to non-target embolization

  30 days post index procedure

• Occurrence of symptomatic brain radiation necrosis requiring medical or surgical intervention and confirmed by pathology

  30 days post index procedure

• The number of Grade 4 neutropenia events persisting for longer than 5 days

  30 days post index procedure

• The number of grade 4 febrile neutropenia

  30 days post index procedure

• The number of grade 4 thrombocytopenia or grade 3 thrombocytopenia with hemorrhage

  30 days post index procedure

Secondary Outcomes (7)

• 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.

  Enrollment through 6 months post index procedure

• Change in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS).

  Enrollment through 6 months post index procedure

• Change in post-treatment neurological function as assessed by the modified Rankin Scale (mRS).

  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.

  Pre-screening through post-device delivery PET-CT/MRI.

• Objective Response Rate* (ORR) from first patient enrolled through study completion

  Enrollment through 6 months post index procedure

Study Arms (4)

Treatment Group A

EXPERIMENTAL

Subjects in which the perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Device: TheraSphere GBM

Treatment Group B

EXPERIMENTAL

Subjects in which the perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Device: TheraSphere GBM

Treatment Group C

EXPERIMENTAL

Subjects in which the perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Device: TheraSphere GBM

Treatment Group D

EXPERIMENTAL

Subjects in which the perfused volume encompasses the dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Device: TheraSphere GBM

Interventions

TheraSphere GBM DEVICE

Single treatment of TheraSphere GBM device

Also known as: TheraSphere™ GBM Y-90 Glass Microspheres (TheraSphere GBM)

Treatment Group A; Treatment Group B; Treatment Group C; Treatment Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
• Life expectancy ≥ 12 weeks
• Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule
• History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
• Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria
• Prior surgery and treatment with combination of radiotherapy and chemotherapy ± Tumor Treating Fields (Optune®)
• Prior cranial radiation dose \< 66 Gy
• WHO performance status ≤ 2
• The interval since completion of cranial radiotherapy must be \> 6 months, unless there is tissue confirmation of tumor recurrence/progression outside the previous radiation treatment field, in which case the interval since completion of cranial radiation must be at least 12 weeks
• Interval since last systemic therapy until presumed date of intervention ≥ 1 cycle or ≥ 2 biological half-lives, i.e.
• ≥ 4 weeks since last dose of temozolomide
• ≥ 6 weeks since last dose of lomustine or other nitrosourea
• ≥ 2 weeks since last dose of a small molecule targeted agent (Tyrosine Kinase Inhibitor or similar)
• ≥ 6 weeks from last dose of last intravenous bevacizumab infusion, or other antibody-based VEGF therapy
• If receiving steroids, patient should be on a stable or decreasing dose equivalent to dexamethasone ≤ 6 mg/d, for at least 7 days prior to registration

You may not qualify if:

• Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain, brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor approximating or invading the brainstem and/or optic chiasma, leptomeningeal disease, or extracranial metastatic disease
• Have received more than 1 course of prior cranial radiotherapy (EBRT)
• Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy
• Have received more than 2 systemic treatment protocols (lines of treatment), not including maintenance temozolomide
• Have received prior intra-arterial cerebral infusion therapy
• Have received more than 2 surgical GBM-related procedures
• Have received prior thoracic radiation therapy
• Are at increased risk of wound dehiscence by the discretion of the investigators (e.g. brain surgery within the last 3 months, poor skin condition, and/or previously infected surgical field or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)
• Have uncontrolled epilepsy
• Have severe and/or insufficiently controlled intercurrent illness; patients with the following are not eligible:
• Hypertension grade 3 or higher without adequate control on medications
• Symptomatic or unstable cardiac disease, known to have right-to-left shunts, or severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg)
• Pulmonary insufficiency (arterial oxygen pressure (Pa,O2) of \< 60 mmHg, or oxygen saturation (Sa,O2) of \< 90%) as measured by fingertip pulse oximeter
• Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)
• Pneumonitis

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (9)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

WITHDRAWN

University of California San Diego

San Diego, California, 92103, United States

NOT YET RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Mayo Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Northwestern Univerity

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins Interventional Radiology Center

Baltimore, Maryland, 21287, United States

WITHDRAWN

Washington University School of Medicine

St Louis, Missouri, 63130, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 41276366 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Riad Salem, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Roger Stupp, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Linda

CONTACT

952-201-3102; Sally.Linda@bsci.com

Lilian Liu Pan

CONTACT

858-888-5682; Lilian.LiuPan@bsci.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The TheraSphere GBM Y-90 Glass Microsphere System (TheraSphere GBM) is an yttrium-90 (Y-90) glass microsphere therapy for selective internal radiation therapy (endovascular radiotherapy) in recurrent GBM patients. Up to 36 evaluable subjects will be enrolled in Groups A, B, C and D.

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 31, 2022
• Study Start: July 30, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)