Last updated on December 2016

Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy Temozolomide and BMX-001


Brief description of study

This is a Phase 1/2 study of newly diagnosed patients with high grade glioma (HGG) undergoing standard radiation therapy and temozolomide treatment. BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against deterioration of cognition and impairment of quality of life. In Phase 1 safety and tolerability of BMX-001 will be assessed using a two-stage Continual Reassessment Method (CRM). BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. In Phase 2 both safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be assessed. Twenty-four patients will be randomized to the treatment arm that will receive BMX-001 while undergoing chemoradiation and 24 patients randomized to receive chemoradiation alone. The investigators hypothesize that BMX-001 when added to standard radiation therapy and temozolomide will be safe at pharmacologically relevant doses in patients with newly diagnosed high grade glioma. The investigators also hypothesize that in Phase 2 of this study, the addition of BMX-001 will positively impact the overall survival and improve objective measures of cognition in newly diagnosed high grade glioma patients.

Clinical Study Identifier: NCT02655601

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Sarah Woodring

Duke Cancer Institute
Durham, NC United States
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