Phase I Study of Oral Abexinostat PCI-24781 Combined with Metronomic Temozolomide for Adults with Recurrent High Grade Glioma

What this Trial Is About

Researchers are studying recurrent high grade glioma, including glioblastoma and other grade III or IV gliomas, which are aggressive brain tumors with poor survival even after standard treatments like radiation and temozolomide chemotherapy. This study aims to find the recommended dose and assess side effects of combining PCI-24781Abexinostat with low-dose continuous temozolomide for these recurrent tumors, which currently have limited treatment options and low progression-free survival rates. Participants will be assigned to one of four PCI-24781Abexinostat dose levels, taken orally twice daily on specific days within each 28-day cycle, alongside metronomic temozolomide at 50 mgm2 twice daily continuously. The study uses a dose escalation design to find the optimal dose based on early toxicities. Treatment continues until the disease progresses or side effects become intolerable. During the study, participants will undergo assessments including monitoring for adverse events, blood tests to measure drug effects on histone acetylation, tumor response evaluations, and quality of life questionnaires. Researchers will also study pharmacokinetics and molecular markers related to tumor response. Follow-up for progression-free and overall survival will continue for up to 36 months, with safety monitoring lasting up to 25 months.

A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma