TheraSphere GBM for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioblastoma+3 More
TheraSphere GBM - Device
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

1 of 3

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

1 of 3

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: Device

Trial 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 preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

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.