A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Gliobla… (NCT06552260) | Clinical Trial Compass
RecruitingEarly Phase 1
A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
United States27 participantsStarted 2025-02-19
Plain-language summary
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)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥18 years
* Histopathologically confirmed IDH-wildtype glioblastoma, WHO Grade 4, and variants including gliosarcoma as per WHO 2021 criteria (38).
* Prior treatment with radiotherapy with or without chemotherapy.
* Recurrent or progressive disease with no more than 2 prior relapses.
* Confirmed measurable disease per RANO 2.0 for GBM.
* Tumor is documented as IDH1/2 wildtype by direct DNA sequencing, provided that it is performed in a CLIA/CAP-certified laboratory.
* Availability of archival formalin fixed paraffin-embedded (FFPE) tumor tissue block or 20 unstained FFPE slides (5 μm thick) from any prior surgery for mutation testing and additional sequencing.
* Karnofsky Performance Status of ≥ 60.
* Candidate for surgical resection.
* Tumor tissue extending to cortical gray matter based on MRI.
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
* Women of child-bearing potential (WOCBP), defined as any individual assigned female at birth physiologically capabl…
What they're measuring
1
The effect of troriluzole on high-gamma band power (a measure of neuronal activity) via electrocorticography during surgical resection