RecruitingPhase 1NCT05303467

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

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

Sponsor

Boston Scientific Corporation

Enrollment

36 participants

Start Date

Jul 30, 2022

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Multiforme Recurrent Glioblastoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria29

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
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
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.
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

Exclusion Criteria24

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
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)

Interventions

DEVICETheraSphere GBM

Single treatment of TheraSphere GBM device

Locations(9)

University of Alabama Birmingham

Birmingham, Alabama, United States

University of California San Diego

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Mayo Jacksonville

Jacksonville, Florida, United States

Northwestern Univerity

Chicago, Illinois, United States

Johns Hopkins Interventional Radiology Center

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Lenox Hill Hospital

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05303467

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