TheraSphere for Recurrent Brain Cancer
(FRONTIER Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires a certain period without specific medications before participation. For example, you need to wait at least 4 weeks after the last dose of temozolomide, 6 weeks after lomustine, and 2 weeks after a small molecule targeted agent. If you're on steroids, your dose should be stable or decreasing for at least 7 days before joining.
What data supports the effectiveness of the treatment TheraSphere GBM for recurrent brain cancer?
The research suggests that treatments like stereotactic radiosurgery (SRS) and high-dose-rate brachytherapy (HDR-BRT), which are similar to TheraSphere GBM, have shown improved survival in patients with recurrent glioblastoma by delivering targeted radiation to the tumor while sparing healthy brain tissue.12345
How is the TheraSphere treatment different from other treatments for recurrent brain cancer?
TheraSphere is unique because it involves the use of tiny glass beads filled with a radioactive substance, which are delivered directly to the tumor site, providing targeted radiation therapy. This method is different from traditional treatments like surgery, chemotherapy, or external radiation, as it aims to minimize damage to surrounding healthy brain tissue.16789
What is the purpose of this trial?
This trial is testing a new radiation treatment using tiny radioactive beads for patients with aggressive brain cancer that has come back. The treatment aims to target the tumor more precisely and reduce side effects compared to standard treatments. GammaTile is a device that uses cesium-131 radiation-emitting seeds embedded in a collagen tile to provide targeted radiation therapy for brain tumors.
Research Team
Riad Salem, M.D.
Principal Investigator
Northwestern University
Roger Stupp, M.D.
Principal Investigator
Northwestern University
Eligibility Criteria
This trial is for adults over 18 with recurrent glioblastoma who've had prior treatment but not more than one round of radiotherapy or two surgeries. They must have adequate organ function, a life expectancy of at least 12 weeks, and be able to follow the trial procedures. Pregnant women can't participate, and those who can bear children must use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TheraSphere GBM Y-90 Glass Microsphere therapy via intra-arterial delivery for selective internal radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of neurological function
Treatment Details
Interventions
- TheraSphere GBM
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology