Troriluzole for Recurrent Brain Cancer

Recruiting at 2 trial locations

Overseen By Eudocia Lee, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Eudocia Quant Lee, MD

Must not be taking: CYP1A2 inhibitors, Anti-glutamergic agents

Disqualifiers: Leptomeningeal disease, Hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: 13

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying troriluzole as a possible treatment for recurrent glioblastoma. The name of the study drug involved in this research study is: -Troriluzole (a tripeptide prodrug of riluzole)

Research Team

Eudocia Q Lee, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for individuals with recurrent glioblastoma, which is a type of brain tumor that has returned after treatment. Participants should not have any mutations in the IDH gene.

Inclusion Criteria

My tumor does not have IDH1/2 mutations, confirmed by DNA testing.

My MRI shows the tumor has reached the brain's surface layer.

I can care for myself but may not be able to do active work.

Exclusion Criteria

Laboratory values at the Screening Visit outside specified ranges

I have recently been treated with cancer medications.

I have not had major surgery in the last 28 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-surgical Treatment

Participants in Group A receive Troriluzole prior to standard-of-care tumor resection surgery

6 days

Daily visits for drug administration

Surgery

Standard-of-care tumor resection surgery with pre-op and post-op MRI

1 day

1 visit (in-person)

Post-surgical Treatment

Participants receive Troriluzole in 28-day cycles

Ongoing cycles

Daily visits for drug administration, MRIs every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Every 3 months for 1 year, then every 6 months for 3 years

Treatment Details

Interventions

• Troriluzole

Trial Overview The study is testing Troriluzole, a drug designed to treat recurrent glioblastoma. It's given before surgery to see if it can help control the growth of the tumor.

Participant Groups

Group I: Group B: Surgery + Troriluzole Experimental Treatment 1 Intervention

9 participants will be randomly assigned to this group and with complete: * Baseline visit with assessments and MRI * Day 0: pre-op MRI * Day 0: standard of care surgical resection of tumor * Day 0: post-op MRI * Cycle 1 through Cycle 3: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * Cycle 3 through End of Treatment: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * MRIs every 8 weeks while on treatment. * End of study visit with MRI * Follow up every 3 months for 1 year, and then every 6 months for the next 3 years.

Group II: Group A: Presurgical Troriluzole Experimental Treatment 1 Intervention

18 participants will be randomly assigned to this group and with complete: * Baseline visit with assessments and MRI. * Cycle 0: * Day -6 through Day 0: Predetermined dose of Troriluzole 2x daily. * Day 0: pre-op MRI * Day 0: standard of care surgical resection of tumor * Day 0: post-op MRI * Cycle 1 through Cycle 3: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * Cycle 3 through End of Treatment: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * MRIs every 8 weeks while on treatment. * End of study visit with MRI * Follow up every 3 months for 1 year, and then every 6 months for the next 3 years.

Who Is Running the Clinical Trial?

Eudocia Quant Lee, MD

Lead Sponsor

Trials

2

Recruited

110+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Biohaven Pharmaceuticals, Inc.

Industry Sponsor

Trials

49

Recruited

30,100+