A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Ugonma Chukwueke
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)
Description
This is an open-label, randomized window-of-opportunity study of Troriluzole in participants with surgically accessible, recurrent isocitrate dehydrogenase wild-type (IDH WT) glioblastoma (GBM). Surgical window-of-opportunity clinical trials test how active the investigational drug is on tumors. "Investigational" means that the drug is being studied. Participants will be randomized using a 2:1 ratio into one of two study treatment groups: Group A versus Group B. Randomization means a participant is placed into a study group by chance. Group A will receive Troriluzole prior to and after standa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTroriluzole
Tripeptide prodrug of Riluzole, 100 mg capsule, taken orally per protocol.
Locations (3)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts