Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma

PRIMARY OBJECTIVES: I. Determine the lowest dose of dexamethasone that needs to be co-administered with azeliragon for treatment of post-resection cerebral edema in patients with glioblastoma. II. Assess the safety of administering azeliragon peri-operatively to patients with glioblastoma. SECONDARY OBJECTIVES: I. Describe post-operative changes in levels of cytokines and chemokines in brain interstitium and peripheral blood in study participants. II. Quantitatively assess changes in the volume of cerebral edema post-operatively in study participants. III. Determine brain concentrations of azeliragon in resected tumor tissue from Arm 1 participants. EXPLORATORY OBJECTIVES: I. Describe post-operative changes in levels of RAGE ligands in brain interstitium, peripheral blood, and resection cavity fluid (when possible to obtain) in study participants. II. Describe changes in levels of cytokines, chemokines, and immune cell populations in resection cavity fluid (when possible to obtain). III. Describe differences in levels of cytokines, chemokines and RAGE ligands between patients in Arm 1 and Arm 2. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive azeliragon orally (PO) and dexamethasone PO or intravenously (IV) throughout the study. Patients also undergo collection of cavity fluid and blood samples, computed tomography (CT) scan, and brain magnetic resonance imaging (MRI) with or without contrast throughout the study. ARM II: Patients receive dexamethasone PO or IV throughout the study. Patients also undergo collection of cavity fluid and blood samples, CT scan, and brain MRI with or without contrast throughout the study.