Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of microtubule-targeted agent BAL101553 (BAL101553) in combination with standard radiation in patients with newly diagnosed MGMT promoter unmethylated GBM. SECONDARY OBJECTIVES: I. To estimate safety and tolerability of the combination of BAL101553 in combination with standard radiation in patients with newly diagnosed MGMT promoter unmethylated GBM. II. To determine overall and progression-free survival. OUTLINE: This was a dose escalation study of the microtubule-targeted agent BAL101553. Patients received BAL101553 orally (PO) once daily (QD) for 6 weeks, concurrent with standard radiation therapy (RT) 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. This treatment period was followed by a 4-week no-treatment period. The duration of study treatment was defined as these 6 weeks of treatment plus the 4 weeks of rest. The safety evaluation period was the 10 weeks from start of treatment After completion of study treatment, patients were followed up at 30 days, and then every 2 months for 2 years and then every 6 months thereafter.