ACTR-41. A PHASE II, SINGLE ARM STUDY OF OPTUNE® IN BEVACIZUMAB-NAIVE SUBJECTS WITH RECURRENT WHO GRADE III MALIGNANT GLIOMA

Abstract

There is an unmet clinical need for the treatment of progressive or recurrent anaplastic glioma (World Health Organization [WHO] grade III) with poor median survival despite available chemotherapy. Published literature indicates that targeting mitosis via tumor treating fields (TTF) in rapidly dividing cancer cells by disrupting both spindle formation and normal cytokinesis selectively kills or arrests growth in glioma cell lines. The Optune® system is a novel anti-mitotic cancer therapy approved by the FDA in 2011 for the treatment of recurrent (supratentorial) glioblastoma (GB) (WHO grade IV) based on the results of a phase 3 clinical trial comparing TTF monotherapy with physician’s choice chemotherapy in patients with recurrent GB demonstrating comparable overall survival and improved quality of life. No data is currently available on the response of WHO grade III malignant glioma to this technology. In addition, no biomarker is yet available in order to predict which patients will have a better response to the Optune® technology. This is a phase 2, single arm study in patients with WHO grade III malignant glioma who have had progressive disease during first-line treatment with radiation, temozolomide (TMZ) and/or procarbazine/lomustine/vincristine (PCV) and who have not previously received bevacizumab (BEV) or any experimental agents. All patients are provided with the Optune® device. Frequency titration experiments are conducted in vitro. This is a prospective, open label study. The primary objective will be to determine the efficacy of Optune® in recurrent malignant glioma patients (6-month progression-free survival). The secondary objectives will be to evaluate the safety and efficacy of Optune® in the subject population and to see if the presence of 1p19q LOH, and/or IDH1 mutation, confers a better response to Optune®.