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

Phase 1

Recruiting

• Conditions: Glioblastoma Multiforme; Recurrent Glioblastoma

• Registration Number: NCT05303467
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-3-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Subject is 18 years or older and has signed and dated the trial informed consent<br> form (ICF)<br><br> 2. Life expectancy = 12 weeks<br><br> 3. Subject is willing and able to comply with the trial testing, procedures, and<br> follow-up schedule<br><br> 4. History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO<br> criteria<br><br> 5. Have radiographic evidence of tumor progression/recurrence with measurable disease<br> (= 1 cm to = 5cm bidirectional diameters) by contrast-enhancement on MRI, according<br> to RANO criteria<br><br> 6. Prior surgery and treatment with combination of radiotherapy and chemotherapy ±<br> Tumor Treating Fields (Optune®)<br><br> 7. Prior cranial radiation dose < 66 Gy<br><br> 8. WHO performance status = 2<br><br> 9. The interval since completion of cranial radiotherapy must be > 6 months, unless<br> there is tissue confirmation of tumor recurrence/progression outside the previous<br> radiation treatment field, in which case the interval since completion of cranial<br> radiation must be at least 12 weeks<br><br> 10. Interval since last cytotoxic therapy until presumed date of intervention = 1 cycle<br> or = 2 biological half-lives, i.e.<br><br> 1. = 4 weeks since last dose of temozolomide<br><br> 2. = 6 weeks since last dose of lomustine or other nitrosourea<br><br> 3. = 2 weeks since last dose of a small molecule targeted agent (Tyrosine Kinase<br> Inhibitor or similar)<br><br> 4. = 12 weeks from last dose of last intravenous bevacizumab infusion, or other<br> antibody-based VEGF therapy<br><br> 11. If receiving steroids, patient should be on a stable or decreasing dose equivalent<br> to dexamethasone = 6 mg/d, for at least 7 days prior to registration<br><br> 12. Have adequate organ and bone marrow function within 14 days prior to registration,<br> as defined below:<br><br> 1. INR = 1.2 (in absence of anticoagulation)<br><br> 2. Platelets = 100,000/L<br><br> 3. Creatinine =1.5 mg/dL<br><br> 4. Absolute Neutrophil Count =1.5 x 10^9/L<br><br> 5. Hemoglobin =9.0 g/dL<br><br> 13. Have a negative pregnancy test within 14 days prior to registration on study (for<br> FOCBP, female of child-bearing potential)<br><br> 14. Subject is a male or non-pregnant female. If female of child-bearing potential, and<br> if sexually active must be using, or agree to use, a medically acceptable method of<br> birth control as confirmed by the investigator<br><br> 15. Angiographic Mapping Inclusion Criteria:<br><br> 1. Accessible neurovascular anatomy that allows for safe microcatheter placement<br> (up to two locations) to infuse TheraSphere GBM to treat all of the T1<br> enhancing component of lesion confirmed by neuro-interventional team.<br><br> 2. Total treatment volume is = 150cc in the non-dominant hemisphere and<br> non-eloquent regions as determined by multidisciplinary team. Eloquent regions<br> should be defined as areas of the brain that maintain language, vision, sensory<br> and motor function<br><br>Exclusion Criteria:<br><br> 1. Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa,<br> tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain,<br> brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor<br> approximating or invading the brainstem and/or optic chiasma, leptomeningeal<br> disease, or extracranial metastatic disease<br><br> 2. Have received more than 1 course of prior cranial radiotherapy (EBRT)<br><br> 3. Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy<br><br> 4. Have received more than 2 systemic treatment protocols (lines of treatment), not<br> including maintenance temozolomide<br><br> 5. Have received prior intra-arterial cerebral infusion therapy<br><br> 6. Have received more than 2 surgical GBM-related procedures<br><br> 7. Have received prior thoracic radiation therapy<br><br> 8. Are at increased risk of wound dehiscence by the discretion of the investigators<br> (e.g. brain surgery within the last 3 months, poor skin condition, and/or previously<br> infected surgical field or any other condition that is of increased infectious risk<br> in the opinion of the neurosurgeon)<br><br> 9. Have uncontrolled epilepsy<br><br> 10. Have severe and/or insufficiently controlled intercurrent illness; patients with the<br> following are not eligible:<br><br> 1. Hypertension grade 3 or higher without adequate control on medications<br><br> 2. Symptomatic or unstable cardiac disease, known to have right-to-left shunts, or<br> severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg)<br><br> 3. Pulmonary insufficiency (arterial oxygen pressure (Pa,O2) of < 60 mmHg, or<br> oxygen saturation (Sa,O2) of < 90%) as measured by fingertip pulse oximeter<br><br> 4. Ongoing or active bacterial or viral infection requiring systemic treatment<br> (including HIV)<br><br> 5. Pneumonitis<br><br> 6. Psychiatric illness/social situations that would limit compliance with study<br> requirements<br><br> 7. Peripheral Neuropathy = grade 1<br><br> 8. Any other illness or condition that the treating investigator feels would<br> interfere with study compliance or would compromise the patient's safety, study<br> endpoints or longevity<br><br> 11. Are currently pregnant or breast feeding (unless patient agrees to stop<br> breastfeeding)<br><br> 12. Patients with a history of an active other malignancy within 1 year prior to<br> registration. NOTE: Exceptions to this requirement include adequately treated<br> non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of<br> disease, or recurrent glioblastoma<br><br> 13. Patients with a history of ischemic cerebral disease and/or at risk of cerebral<br> herniation<br><br> 14. Medical contraindication to undergo contrast-enhanced magnetic resonance imaging<br> (MRI)<br><br> 15. Known history of hypersensitivity reactions to iodinated and/or gadolinium-based<br> contrast<br><br> 16. Subject has received any other investigational agents within 4 weeks of treatment,<br> or is currently participating, or plans to participate in, another investigational<br> trial that may confound the results of this trial (unless written approval is<br> received from the Boston Scientific study team)<br><br> 17. Angiographic Mapping Exclusion Criteria: Patients with significant vascular disease,<br> significant AV shunting, or anatomic tortuosity on MR/CT Angiogram precluding safe<br> or feasible vascular access or an eloquent high-risk vascular distribution of the<br> treatment plan

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of grade 3-5 non-hematological toxicities;The number of = grade 3 CNS toxicities related to non-target embolization;Occurrence of symptomatic brain radiation necrosis requiring medical or surgical intervention and confirmed by pathology;The number of Grade 4 neutropenia events persisting for longer than 5 days;The number of grade 4 febrile neutropenia;The number of grade 4 thrombocytopenia or grade 3 thrombocytopenia with hemorrhage

Secondary Outcome Measures

Name	Time	Method
Rate of any treatment-related adverse events and treatment-related serious adverse events (not including predefined Limiting Toxicities) from first patient enrolled through study completion.;Change in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS).;Change in post-treatment neurological function as assessed by the modified Rankin Scale (mRS).;Technical Success/Feasibility of TheraSphere GBM-- ability to deliver the target absorbed dose (+/- 20%) to the perfused volume for all patients treated with the device. Assessed from pre-screening through post-device delivery PET-CT/MRI.;Objective Response Rate* (ORR) from first patient enrolled through study completion;Progression Free Survival* (PFS) from first patient enrolled through study completion;Overall Survival (OS) from first patient enrolled through study completion