TRLS-02. FEASIBILITY OF EVALUATING ABEMACICLIB NEUROPHARMACOKINETICS OF DIFFUSE MIDLINE GLIOMA USING INTRATUMORAL MICRODIALYSIS

Abstract BACKGROUND Diffuse midline gliomas (DMG) are the most aggressive brain tumors of childhood and young adults, with documented 2-year survival rates <10%. Treatment failure is due in part to function BBB. Intratumoral microdialysis sampling an effective tool determine entry varied agents could help provide a better understanding relationship drug permeability DMG treatment response. METHODS This non-randomized, single-center, phase 1 clinical trial. Up seven adult (18-39 years) patients recurrent high-grade or diffuse glioma will be enrolled goal 5 completing trial over anticipated 24 months. All take abemaciclib pre-operatively for 4.5 days at twice daily dosing. Patients undergo resection biopsy, placement catheter, 48 hours dialysate coupled timed plasma collections. If intratumoral tumor concentrations >10nmol/L, tissue studies demonstrate CDK inhibition, then restart therapy along temozolomide administered maintenance discontinued evidence radiologic disease progression. DISCUSSION The poor associated underscore need improved means evaluate efficacy delivery peritumoral tissue. findings this novel study, real-time measurements BBB which have potential influence future prognostic diagnostic decisions such lethal limited options. TRIAL REGISTRATION: Clinicaltrials.gov, NCT05413304. Registered June 10, 2022, Abemaciclib Neuropharmacokinetics Midline Glioma Using Microdialysis; https://clinicaltrials.gov/ct2/show/NCT05413304?term=22c0003&draw=2&rank=1