Abstract
2023 Background: Glioblastoma multiforme (GBM) is the most common brain cancer. Front-line systemic therapy with temozolomide is often ineffective due to O6-methylguanine-DNA-methyltransferase (MGMT)-mediated resistance. Dianhydrogalactitol (VAL-083) is a bi-functional DNA alkylating agent that crosses the blood-brain barrier and overcomes resistance to MGMT in vitro. The goal of this clinical trial is to determine an appropriate dose for phase III trials in refractory GBM. Methods: Open-label, single-arm phase I/II dose-escalation study in patients with histologically-confirmed GBM, previously treated with radiation and must have failed both bevacizumab and temozolomide, unless contraindicated. The study utilizes a 3+3 dose-escalation design. Patients receive VAL-083 IV on days 1, 2, and 3 of a 21-day cycle. Tumor response is assessed according to RANO criteria prior to every other 21-day treatment cycle. Results: 25 patients have been enrolled across 8 dose cohorts ranging from 1.5 to 50mg/m2/d. A dose ...
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