Table 4:
Innovative surgical clinical trials for glioma
PI | Jian Campian | Michael Vogelbaum | Josh Rubin | John Boockvar | John Boockvar | Adam Sonabend |
Identifier | NCT02311582 | NCT04608812 | NCT02372409 | NCT04222309 | NCT03630289 | NCT04528680 |
Beginning Year | 2014 | 2020 | 2015 | 2020 | 2018 | 2020 |
Estimated Completion | 2021 | 2021 | 2028 | 2021 | 2021 | 2024 |
Trial Phase | Phase I/II | Phase I | Phase II | Phase I | Phase I | Phase I/II |
Age Range | 18+ | 18+ | 3–21 | 18+ | 18+ | 18+ |
Trial N | 58 | 24 | 12 | 10 | 10 | 39 |
Primary Outcome Measure | Maximal Tolerated Dose of MK-3475 when combined with MRI guided laser ablation | Treatment emergent adverse events or dose limiting toxicities | Progression Free Survival | Proportion of patients reporting rapidly progressing disease | Proportion of patients reporting rapidly progressing disease | Dose limiting toxicity |
Surgical Intervention | MRI guided laser ablation for BBB disruption to administer MK-3475 | Convection Enhanced Delivery for OS2966 | MRI guided laser ablation for BBB disruption and administration of doxorubicin or etoposide | Omental Free Tissue Autograft to Bypass BBB | Tissue Autograft of pericranial flap to bypass BBB | Sonication for opening of BBB to deliver paclitaxel |