Troriluzole for Recurrent Brain Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Eudocia Q Lee, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Eudocia Quant Lee, MD

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

Disqualifiers: Leptomeningeal disease, Hepatitis, HIV, others

No Placebo Group

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)

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 am 18 years old or older.

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.

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Brigham and Women's Hospital Boston, MA

Massachusetts General Hospital Cancer Center Boston, MA

Dana-Farber Cancer Institute Boston, MA

Who Is Running the Clinical Trial?

Eudocia Quant Lee, MD Lead Sponsor

National Institutes of Health (NIH) Collaborator

Biohaven Pharmaceuticals, Inc. Industry Sponsor

References