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Glioblastoma MultiformePhase 1FRONTIERNCT05303467

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

A Phase 1 study testing TheraSphere GBM in people with Glioblastoma Multiforme and Recurrent Glioblastoma, run by Boston Scientific Corporation at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TheraSphere GBM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
9 sitesUnited States
Study dates
30 Jul 2022to 30 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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®)
Show all 31Show fewer
  • 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
  • Have adequate organ and bone marrow function within 14 days prior to registration, as defined below:
  • INR ≤ 1.2 (in absence of anticoagulation)
  • Platelets ≥ 100,000/L
  • Creatinine ≤1.5 mg/dL
  • Absolute Neutrophil Count ≥1.5 x 10^9/L
  • Hemoglobin ≥9.0 g/dL
  • Have a negative pregnancy test within 14 days prior to registration on study (for FOCBP, female of child-bearing potential)
  • Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically acceptable method of birth control as confirmed by the investigator
  • Angiographic Mapping Inclusion Criteria:
  • Accessible neurovascular anatomy that allows for safe microcatheter placement (up to two locations) to infuse TheraSphere GBM to treat all of the T1 enhancing component of target lesion confirmed by neuro-interventional team.
  • Total treatment volume is ≤ 150cc as determined by multidisciplinary team.
  • Additional Inclusion Criteria:
  • Group A: perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain
  • Group B: perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain
  • Group C: perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain
  • Group D: perfused volume encompasses the dominant hemisphere and eloquent regions of the brain

Who cannot join

  • 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
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  • 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
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Peripheral Neuropathy ≥ grade 1
  • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety, study endpoints or longevity
  • Are currently pregnant or breast feeding (unless patient agrees to stop breastfeeding)
  • Patients with a history of an active other malignancy within 1 year prior to registration. NOTE: Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease, or recurrent glioblastoma
  • Patients with a history of ischemic cerebral disease and/or at risk of cerebral herniation
  • Medical contraindication to undergo contrast-enhanced magnetic resonance imaging (MRI)
  • Known history of hypersensitivity reactions to iodinated and/or gadolinium-based contrast
  • Subject has received any other investigational agents within 4 weeks of treatment, or is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team)
  • Angiographic Mapping Exclusion Criteria: Patients with significant vascular disease, significant AV shunting, or anatomic tortuosity on MR/CT Angiogram precluding safe or feasible vascular access

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sally Linda contact

952-201-3102

Sally.Linda@bsci.com

Lilian Liu Pan contact

858-888-5682

Lilian.LiuPan@bsci.com

9 sites in 1 country

United States9 sites, 7 recruiting

  • Johns Hopkins Interventional Radiology Center

    Baltimore, Maryland, 21287

    Withdrawn

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

    Withdrawn

  • Northwestern Univerity

    Chicago, Illinois, 60611

    Roger Stupp, MD, 866-587-4322, roger.stupp@northwestern.edu

    Emily R Powell, 312-926-3872, emily.powell@northwestern.edu

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Summer Stovall, 713-745-4243, SStovall@mdanderson.org

    Stephen Chen, MD

    Recruiting

  • Mayo Jacksonville

    Jacksonville, Florida, 32224

    Aleeshba Basil, 855-776-0015, Basil.aleeshba@mayo.edu

    Alfredo Quinones-Hinojosa, MD

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Tamika Wong, 212-434-4836, twong4@northwell.edu

    John Boockvar, MD

    Recruiting

  • University of California San Diego

    San Diego, California, 92103

    Sheila Medina Torne, 858-822-6100, s4medina@health.ucsd.edu

    Zachary Berman, MD

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94143

    Stephanie Lewis, 415-353-2193, NeuroOncNewPatientCoord@ucsf.edu

    Nicholas Butowski, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63130

    Rachel Reed, Rachel.Reed@wustl.edu

    Arindam Chatterjee, M.D.

    Recruiting

Other trials in United States

About this study

Official title: FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM

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.

Read the 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.

Being tested
TheraSphere GBM
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TheraSphere GBMDevice

    Also called TheraSphere™ GBM Y-90 Glass Microspheres (TheraSphere GBM)

    Single treatment of TheraSphere GBM device

Study groups in NCT05303467
Study groupRoleWhat they receive
Treatment Group AExperimentalSubjects 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%.
Receives: Device: TheraSphere GBM
Treatment Group BExperimentalSubjects 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%.
Receives: Device: TheraSphere GBM
Treatment Group CExperimentalSubjects 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%.
Receives: Device: TheraSphere GBM
Treatment Group DExperimentalSubjects 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%.
Receives: Device: TheraSphere GBM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of grade 3-5 non-hematological toxicities

    Measured: 30 days post index procedure

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

    Measured: 30 days post index procedure

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

    Measured: 30 days post index procedure

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

    Measured: 30 days post index procedure

  5. The number of grade 4 febrile neutropenia

    Measured: 30 days post index procedure

  6. The number of grade 4 thrombocytopenia or grade 3 thrombocytopenia with hemorrhage

    Measured: 30 days post index procedure

Secondary outcomes (7)

  1. 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.

    Measured: Enrollment through 6 months post index procedure

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

    The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.

    Measured: Enrollment through 6 months post index procedure

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

    The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability on a scale from 0 (no symptoms at all) to 6 (death).

    Measured: Enrollment through 6 months post index procedure

  4. 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.

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

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

    Measured: Enrollment through 6 months post index procedure

  6. Progression Free Survival* (PFS) from first patient enrolled through study completion

    Measured: Enrollment through 6 months post index procedure

  7. Overall Survival (OS) from first patient enrolled through study completion

    Measured: Enrollment through 6 months post index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start30 Jul 2022
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05303467
Sponsor's protocol ID
S2478
Acronym
FRONTIER
Status last verified
Sep 2026
First submitted
10 Mar 2022
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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 41276366

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TheraSphere GBM in people with Glioblastoma Multiforme and Recurrent Glioblastoma, run by Boston Scientific Corporation at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sally Linda (952-201-3102, Sally.Linda@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of grade 3-5 non-hematological toxicities (time frame: 30 days post index procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05303467, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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