TheraSphere GBM for Glioblastoma
Phase-Based Progress Estimates
Effectiveness
Safety
Glioblastoma+3 More
TheraSphere GBM - DeviceEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new way to treat recurrent brain cancer that is less invasive and has fewer side effects than current methods.
Eligible Conditions
- Glioblastoma Multiforme (GBM)
- Glioblastoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 7 Secondary · Reporting Duration: Enrollment through 6 months post index procedure
Day 30
Operative Surgical Procedures
The number of Grade 4 neutropenia events persisting for longer than 5 days
The number of grade 3-5 non-hematological toxicities
The number of grade 4 febrile neutropenia
The number of grade 4 thrombocytopenia or grade 3 thrombocytopenia with hemorrhage
The number of ≥ grade 3 CNS toxicities related to non-target embolization
Month 6
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).
Objective Response Rate* (ORR) from first patient enrolled through study completion
Overall Survival (OS) from first patient enrolled through study completion
Progression Free Survival* (PFS) from first patient enrolled through study completion
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.
Pre-screening through post-device delivery PET-CT/MRI.
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.
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment
1 of 1
Experimental Treatment
12 Total Participants · 1 Treatment Group
Primary Treatment: TheraSphere GBM · No Placebo Group · Phase < 1
Treatment
Device
Experimental Group · 1 Intervention: TheraSphere GBM · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment through 6 months post index procedure
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
672 Previous Clinical Trials
918,670 Total Patients Enrolled
2 Trials studying Glioblastoma
13 Patients Enrolled for Glioblastoma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a life expectancy ≥ 12 weeks.
You have a history of a histologically confirmed diagnosis of glioblastoma per WHO criteria.
You are willing and able to comply with the trial testing, procedures, and follow-up schedule.
You 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.
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 must be at least 12 weeks.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments