Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 1: TheraSphere GBM for Glioblastoma Multiforme
The FRONTIER Study is a prospective, treatment, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are TheraSphere GBM. The registry lists allocation as randomized. The FRONTIER Study is a prospective, treatment, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.
They plan to enroll about 36 people at 9 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM
Interventions: TheraSphere GBM
Primary outcome (registry wording): The number of grade 3-5 non-hematological toxicities
Who it is for (from inclusion criteria)
Ages 18 Years to any
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
Who the registry excludes
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
This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy.
Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.
Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05303467?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05303467?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.