An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM (ODYSSEY)

Boston Scientific

Status: Not yet enrolling

Conditions: Recurrent Glioblastoma

Treatments: Device: Device: TheraSphere GBM treatment of TheraSphere GBM device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07867886

CIV-2025-11-055434 (Other Identifier)

S2526

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 measurable tumor progression/recurrence according to RANO 2.0 criteria

• Target lesion volume does not exceed 70 cm^3

• Prior surgery and treatment with combination of radiotherapy and chemotherapy ± Tumor Treating Fields (Optune®)

• ECOG performance status ≤ 2

• The interval since completion of external beam cranial radiotherapy must be > 6 months, unless there is 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 index procedure

  1. ≥ 4 weeks since last dose of temozolomide
  2. ≥ 4 weeks since last dose of lomustine or other nitrosourea
  3. ≥ 2 weeks since last dose of any oral targeted therapy (Tyrosine Kinase inhibitor or similar)
  4. ≥ 6 weeks from last dose of last intravenous bevacizumab infusion, or other antibody-based anti VEGF therapy
  5. ≥ 4 weeks since last dose of investigational agents or patient has on-going < Grade 2 AEs related to investigational agent.

• 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 index procedure

• Have adequate organ and bone marrow function within 14 days prior to index procedure, as defined below:

  1. INR ≤ 1.5 (in absence of anticoagulation)
  2. Platelets ≥ 75,000/L
  3. Creatinine ≤1.5 mg/dL
  4. Absolute Neutrophil Count ≥1.5 x 109/L
  5. Hemoglobin ≥9.0 g/dL

• For female of child-bearing potential:

  1. Have a negative pregnancy test within 14 days prior to index procedure
  2. If sexually active must be using, or agree to use, an acceptable method of birth control as confirmed by the investigator for the duration of their participation in the study
  3. If currently breastfeeding, must agree to stop breastfeeding

• Angiographic Criteria:

The intent of therapy should be to encompass the entire radiographically defined target lesion within the PV b. Each PV is ≤ 150cc, with the total PV not exceeding 400cc

Exclusion criteria

None of the following exclusion criteria can be met:

• 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

• Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy

• Have received more than 2 systemic anti-tumor treatment protocols (lines of treatment), not including neoadjuvant or adjuvant temozolomide (oral or IV)

• Have received more than 2 surgical GBM-related procedures

• Patients with a history of stroke, ischemic cerebral disease, and/or at risk of cerebral herniation

• Are at increased risk of wound dehiscence by the discretion of the investigators (e.g. recent brain surgery, poor skin condition, and/or previously infected surgical field or any other condition that is of increased infectious risk in the opinion of the treatment team)

• Have uncontrolled epilepsy

• Have severe and/or insufficiently controlled intercurrent illness; patients with the following are not eligible:

  1. Hypertension grade 3 or higher without adequate control on medications
  2. Symptomatic or unstable cardiac disease,
  3. Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)
  4. Psychiatric illness/social situations that would limit compliance with study requirements
  5. Peripheral Neuropathy ≥ grade 1
  6. Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints

• Patients with a history of an active other malignancy within 1 year prior to index procedure. NOTE: Exceptions to this requirement include adequately treated non-melanoma skin cancer or carcinoma in situ without evidence of disease

• Medical contraindication to undergo contrast-enhanced magnetic resonance imaging (MRI)

• Known history of severe uncorrectable reactions to iodinated and/or gadolinium-based contrast

• Subject 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 Criteria: Patients with evident AV shunting, vascular disease or tortuosity precluding safe or feasible vascular access, or patient vasculature not conducive to delivery of the therapy on baseline imaging or angiography.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Y90 GBM Device Treatment

Experimental group

Description:

Subjects are eligible if each treatment area supplied by a targeted blood vessel (perfused volume, PV) is 150 cc or less, and the total perfused volume does not exceed 400 cc. This is a dose-escalation study designed to determine the safest and most appropriate radiation dose. The planned radiation dose to the treatment area ranges from 60 Gy to 120 Gy. The study will begin at a dose of 60 Gy, with dose increases of 20 Gy for subsequent patient groups. Patients will be treated in groups of three at each dose level. If a particular dose level is found to be safe, the next group of patients may receive the next higher dose level, stay at the same dose level, or de-escalate the dose level depending on the rate of Dose Limiting Toxicities and Data Monitoring Committee determination.

Treatment:

Device: Device: TheraSphere GBM treatment of TheraSphere GBM device