TheraSphere for Recurrent Brain Cancer

(FRONTIER Trial)

Recruiting at 8 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 tests a new treatment called TheraSphere GBM for individuals with glioblastoma, a type of brain cancer that has recurred after treatment. The study aims to determine if this treatment is safe and can be effectively delivered to patients. Participants will be divided into four groups based on the specific area of the brain affected. Those who have experienced a recurrence of glioblastoma after surgery, radiation, and chemotherapy might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that TheraSphere GBM is likely to be safe for humans?

Research shows that TheraSphere GBM is generally safe for patients with recurring glioblastoma, a type of brain cancer. Early results from the FRONTIER study indicated that most patients did not experience serious side effects. This treatment delivers a high dose of radiation directly to the tumor, helping to protect healthy parts of the brain. Although the study remains in its early stages, these findings suggest the treatment is safe for people so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the TheraSphere GBM treatment for recurrent brain cancer because it represents a novel approach compared to standard treatments like surgery, radiation therapy, and chemotherapy. TheraSphere GBM involves using tiny glass beads filled with radioactive material that are delivered directly to the tumor site, offering a targeted radiation dose to the cancer cells while sparing healthy brain tissue. This method allows for high precision in treating tumors located in both dominant and non-dominant hemispheres, as well as eloquent and non-eloquent brain regions. This targeted delivery could lead to fewer side effects and more effective tumor control, making it a promising option for patients with recurrent brain cancer.

What evidence suggests that TheraSphere GBM might be an effective treatment for recurrent brain cancer?

Research has shown that TheraSphere GBM could be a promising treatment for recurrent glioblastoma (GBM), a very aggressive brain cancer. Early results from the FRONTIER study indicated that this treatment can be done safely and is generally well-tolerated by patients, meaning it doesn't cause major side effects. TheraSphere uses tiny glass beads filled with a radioactive substance called Yttrium-90 (Y-90) to directly target cancer cells. In this trial, participants will join one of four treatment groups, each targeting different regions of the brain. Although it's still early, this method aims to deliver high doses of radiation directly to the tumor while reducing exposure to healthy brain tissue. This approach is being explored because the current outlook for GBM is poor, with less than 7% of patients living five years after diagnosis. ^{1 2 5 6 7}

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. jvir.org jvir.org/article/S1051-0443(24)00819-4/fulltext

Safety and Feasibility of Yttrium-90 TheraSphere in ... These preliminary FRONTIER trial's results indicate that TheraSphere GBM is technically feasible and well-tolerated, with no significant toxicities observed ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05303467

Feasibility Study to Evaluate the Safety of the TheraSphere ... Glioblastoma (GBM) is a highly aggressive brain cancer with a grave prognosis, resulting in <7% of patients surviving to five years post-diagnosis.

3. abta.org abta.org/mindmatters/mm-y-90-internal-radiation-trial-recurrent-gbm/

Y-90 Internal Radiation Trial for Recurrent Glioblastoma The purpose of the FRONTIER study is to determine the ability to safely use the Y-90 technology for the treatment of recurrent glioblastoma.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05303467

NCT05303467 | A Feasibility Study to Evaluate the Safety ... Glioblastoma (GBM) is a highly aggressive brain cancer with a grave prognosis, resulting in <7% of patients surviving to five years post-diagnosis.

5. bostonscientific.com bostonscientific.com/en-US/medical-specialties/interventional-radiology/interventional-oncology/therasphere/clinical-data/frontier-study.html

FRONTIER Study The FRONTIER study is an early feasibility study assessing the use of Boston Scientific Y-90 Glass Microspheres in patients with recurrent glioblastoma (GBM).

6. abta.org abta.org/mindmatters/research/frontier-study/

A Feasibility Study to Evaluate the Safety of ... The purpose of the FRONTIER study is to determine the safety of using this technology to treat recurrent GBM patients.

7. braintumorcenter.ucsf.edu braintumorcenter.ucsf.edu/clinical-trial/feasibility-study-evaluate-safety-therasphere-glioblastoma-gbm-device-patients

A Feasibility Study to Evaluate the Safety of ... By delivering a high dose of radiation to the recurrent tumor and sparing normal tissue, Y90 may offer better tumor control in recurrent GBM patients. Inclusion ...