TheraSphere for Recurrent Brain Cancer

(FRONTIER Trial)

Recruiting at 4 trial locations

Overseen By Lilian Liu Pan

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boston Scientific Corporation

Disqualifiers: Uncontrolled epilepsy, Hypertension, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

36 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

Who Is on the Research Team?

Riad Salem, M.D.

Principal Investigator

Northwestern University

Roger Stupp, M.D.

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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

My organs and bone marrow are functioning well.

Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule

My scans show my tumor has grown and is 1 to 5 cm in size.

Exclusion Criteria

I have serious blood vessel issues that make certain medical procedures unsafe for me.

Subject has received any other investigational agents within 4 weeks of treatment, or 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)

Known history of hypersensitivity reactions to iodinated and/or gadolinium-based contrast

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TheraSphere GBM Y-90 Glass Microsphere therapy via intra-arterial delivery for selective internal radiation therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neurological function

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TheraSphere GBM

Trial Overview The FRONTIER Study is testing TheraSphere GBM's safety and feasibility in patients with recurrent glioblastoma. It's an interventional study where participants receive this device to see if it's safe and technically possible to use as a treatment option.

How Is the Trial Designed?

Group I: Treatment Group D Experimental Treatment 1 Intervention

Subjects in which the perfused volume encompasses the dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Group II: Treatment Group C Experimental Treatment 1 Intervention

Subjects in which the perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Group III: Treatment Group B Experimental Treatment 1 Intervention

Subjects in which the perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Group IV: Treatment Group A Experimental Treatment 1 Intervention

Subjects in which the perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

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

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

CT-guided interstitial HDR brachytherapy for recurrent glioblastoma multiforme. Long-term results. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Surviving Over a Decade With Glioblastoma: A Clinical Course Characterized by Multiple Recurrences, Numerous Salvage Treatments, and Novel Use of Cesium-131 Tiles. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Combined salvage therapies for recurrent glioblastoma multiforme: evaluation of an interdisciplinary treatment algorithm. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Radiosurgery for primary malignant brain tumors. [2019]

5. Sweden pubmed.ncbi.nlm.nih.gov

Gamma knife radiosurgery for local recurrence of glioblastoma. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Glioblastoma-initiating cells: relationship with neural stem cells and the micro-environment. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Large-scale assessment of the gliomasphere model system. [2022]

8. Belgium pubmed.ncbi.nlm.nih.gov

[Glioblastoma, an example of translational research?]. [2015]

9. Japan pubmed.ncbi.nlm.nih.gov

Brain tumor stem cells as research and treatment targets. [2008]