The purpose of this study is to test Y90 glass microspheres for people with recurrent brain cancer. Participation in this study will help researchers find the best dose for the treatment of the disease. The study will look at the safety of the Y90 glass microsphere device and if it works to help stop the growth of the tumor.
In this study, the device is delivered directly to the tumor through the blood vessels/arteries using a catheter(s) (a specialized tubing). The device (very small glass beads) gives radiation directly to the tumor and nearby area.
Although radiation is a standard treatment for most types of brain cancer, the delivery of radiation using the Y90 glass microsphere device differs and is an investigational procedure. To deliver the device a catheter(s) will be inserted through a blood vessel/artery in the forearm or groin, followed by an in-hospital stay after the treatment of up-to 36 hours. Participants will have regular follow-up visits with the study doctor to monitor their health and assess how the tumor responds to treatment. These visits will take place weekly during the first month, monthly for the next five months, and then approximately every two months until one year after treatment.
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 leptomeningeal disease or other primary malignancy metastatic to the brain
Target lesion located in or involving the infratentorial space, thalamus, hypothalamus, internal capsule, or optic chiasma
Have received more than 1 course of prior cerebral radiotherapy (EBRT)
Prior cranial radiation dose ≥ 66 Gy
Single group
Device: TheraSphere GBM treatment of TheraSphere GBM device
DeviceAll patients participating in the study will receive the same device. The study is evaluating the safety and efficacy of the device when it is used to deliver radiation to the area of the brain containing the tumor. The amount of radiation a patient receives depends on the dose group (cohort) to which they are assigned. Patients will be treated in groups of three at each dose level. If a dose level is considered safe, the next group of patients will receive a higher dose
Maximum tolerated radiation absorbed dose (MTRAD) of the Y90 microspheres device to the perfused volume (PV) corresponding to a DLT of smaller equals 33%
The MTRAD of Y-90 microspheres to the PV corresponding to a Dose Limiting Toxicity (DLT) rate of ≤33% through 30 days observation period from the index procedure. A DLT is defined as any device-related ≥Grade 3 adverse event, excluding radiographic-only cerebral edema and symptomatic cerebral edema if symptoms improve within 7 days of initiation of medical management.
Rate of Adverse Events (AEs) throughout follow up period (any causality, severity, and duration):
Rate of radiation-related neurotoxicity throughout follow up period (any causality, severity, and duration)
Rate of Serious AEs throughout follow up period (any causality, severity, and duration)
Rate of procedure-related AEs throughout follow up period (any causality, severity, and duration)
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Boston Scientific Corporation
Lead sponsor
IQVIA RDS Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
