Actively Recruiting
A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Led by Ugonma Chukwueke · Updated on 2025-09-11
27
Participants Needed
3
Research Sites
127 weeks
Total Duration
On this page
Sponsors
U
Ugonma Chukwueke
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histopathologically confirmed IDH-wildtype glioblastoma, WHO Grade 4, including gliosarcoma variants
- Prior treatment with radiotherapy with or without chemotherapy
- Recurrent or progressive disease with no more than 2 prior relapses
- Measurable disease confirmed per RANO 2.0 criteria for glioblastoma
- Tumor documented as IDH1/2 wildtype by DNA sequencing in a certified laboratory
- Availability of archival tumor tissue or slides for mutation testing
- Karnofsky Performance Status of 60 or higher
- Candidate for surgical tumor resection
- Tumor extends to cortical gray matter based on MRI
- Participants with prior or concurrent malignancy that does not interfere with study assessments are eligible
- Participants with cardiac history classified as New York Heart Association class 2B or better
- Women of child-bearing potential must use highly effective contraception during and for 1 month after treatment
- Male participants must use highly effective contraception during treatment and for 3 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- ANC count less than 1,500/mm3 or recent growth-factor support
- Platelets less than 100,000/mm3
- Hemoglobin less than 9 g/dL
- Total bilirubin more than twice the upper limit of normal, except Gilbert's Syndrome cases
- AST or ALT more than 1.5 times upper limit of normal
- Serum creatinine above 1.5 mg/dL or creatinine clearance below 60 mL/min
- Positive serum beta-hCG test in females of childbearing potential
- Presence of diffuse leptomeningeal or extracranial disease
- Prior treatment with troriluzole or riluzole
- Recent treatments with temozolomide, CCNU, BCNU, anti-VEGF therapy, or systemic cancer therapy within specified timeframes
- Use of investigational agents within 28 days before study start
- Radiotherapy within 12 weeks prior to registration unless specific conditions apply
- Significant allergy or toxicity from prior therapy not resolved to Grade 1 or baseline
- Major surgery within 28 days before study drug initiation
- Active or unstable infection requiring systemic therapy
- Contraindications to MRI
- Use of medications that strongly affect CYP1A2 enzymes or cause hepatotoxicity without proper washout
- Pregnant or lactating females
- History of interstitial lung disease
- Known hepatitis B, HIV, or active hepatitis C infection requiring treatment
- Any severe medical or psychiatric condition that increases risk or interferes with study participation
- Difficulty swallowing or malabsorption syndrome affecting drug absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
U
Ugonma Chukwueke, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here