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Troriluzole for Recurrent Brain Cancer

Phase < 1

Waitlist Available

Led By Eudocia Lee, MD, MPH

Research Sponsored by Eudocia Quant Lee, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor documented as IDH1/2 wildtype by direct DNA sequencing in a CLIA/CAP-certified laboratory

Tumor tissue extending to cortical gray matter based on MRI

Must not have

Major surgery within 28 days prior to initiation of study drug

Presence of diffuse leptomeningeal disease or extracranial disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from tumor tissue resected at surgery

Awards & highlights

Summary

This trial is investigating troriluzole as a potential treatment for recurrent glioblastoma, a type of brain cancer. Troriluzole is a medication that is related to another drug

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Troriluzole may include dizziness, gastrointestinal discomfort, fatigue, and changes in liver enzymes. Specific side effect profiles will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

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My diagnosis is Grade 4 glioblastoma, not caused by IDH mutation.

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I have had radiotherapy, with or without chemotherapy.

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My condition has worsened or returned no more than twice.

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

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I am eligible for surgery to remove my cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My cancer has spread to the lining of my brain or outside the brain.

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I have previously been treated with troriluzole or riluzole.

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I have recently undergone radiotherapy.

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I have had a severe allergy or bad reaction to previous treatments.

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I do not have any serious infections needing treatment.

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I am currently pregnant or breastfeeding.

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I have a history of lung scarring or fibrosis.

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I have a history of hepatitis B, HIV, or active hepatitis C needing treatment.

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I have issues swallowing, constant nausea, or have had major bowel surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from tumor tissue resected at surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from tumor tissue resected at surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from tumor tissue resected at surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The effect of troriluzole on high-gamma band power (a measure of neuronal activity) via electrocorticography during surgical resection

Secondary study objectives

Concentrations of Extracellular Glutamate in Resected Tissue by MALDI-MSI

Grade 3-5 Treatment Related Adverse Event

Proliferation Rate (Ki-67) in Resected Tissue

+3 more

Side effects data

From 2020 Phase 3 trial • 881 Patients • NCT03829241

Nausea

Fatigue

Upper respiratory tract infection

Headache

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

Troriluzole - Randomization Phase

Placebo - Randomization Phase

Troriluzole - Randomization Phase/Troriluzole - Extension Phase

Placebo - Randomization Phase/Troriluzole - Extension Phase

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: Surgery + TroriluzoleExperimental Treatment1 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 TroriluzoleExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Troriluzole

2019

Completed Phase 3

~890

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,765 Previous Clinical Trials

8,133,484 Total Patients Enrolled

12 Trials studying Glioblastoma

620 Patients Enrolled for Glioblastoma

Biohaven Pharmaceuticals, Inc.Industry Sponsor

48 Previous Clinical Trials

37,296 Total Patients Enrolled

1 Trials studying Glioblastoma

1,030 Patients Enrolled for Glioblastoma

Eudocia Quant Lee, MDLead Sponsor

1 Previous Clinical Trials

81 Total Patients Enrolled

~18 spots leftby Aug 2026

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