A Phase I Study of Metronomic Temozolomide with PCI-24781 for Patients with Recurrent High Grade Glioma
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: Shonka, Nicole
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05698524?term=NCT05698524&rank=1
Summary
1.1 Primary Objectives
1.1.1 To evaluate the toxicities and determine the recommended dose of PCI-24781 with metronomic temozolomide in subjects with recurrent high grade glioma, [grade III or IV glioma (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma)].
1.2 Secondary Objectives
1.2.1 To evaluate changes in the acetylation of peripheral blood mononuclear cell (PBMC) histones H3 and H4 during treatment
1.2.2 To evaluate for acetylation of histones H3 and H4 using peripheral blood exosomes
1.2.3 To evaluate progression-free and overall survival of subjects with recurrent high grade glioma treated with therapy with PCI-24781 with metronomic temozolomide. Subjects with stable or responsive disease after every 2 cycles will continue on therapy until intolerance or progressive disease.
1.2.4 To descriptively examine quality of life (QOL) using EORTC QLQ-C30, QLQ-BN20 (Appendix A) during treatment.
1.2.5 To characterize the pharmacokinetics (PK) of PCI-24781, temozolomide, and the combination of the 2 drugs.
1.2.6 To measure tumor response.
1.2.7 To correlate molecular profiles with tumor response.