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Tests treatment safety and results for Glioblastoma Multiforme
Official title A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
ClinicalTrials.gov ID: NCT05303467
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures...
- 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
See the full eligibility criteria
Who can 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®)
- 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...
- 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
- 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-treatment team.
- Total treatment volume is ≤ 150cc as determined by multidisciplinary team.
- Additional
- 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
What rules you out
- Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain, brainstem, corticospinal tract, internal capsule...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Diego, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Diego, California, United States; San Francisco, California, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.