The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma

Inclusion Criteria

• •1. Histologically-confirmed newly-diagnosed glioblastoma multiforme.
• •2. No prior treatment for glioblastoma apart from surgical resection.
• •3. No prior treatment for glioblastoma apart from surgical resection.
• •4. Planned for 60 Gray of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
• •5. Manageable risks associated with potential radiation necrosis in the radiation field, based on size of the field and proximity to eloquent brain regions (as assessed by the investigator).
• •6. Aged 18-70 years.
• •7. ECOG performance status 0-2.
• •8. Life expectancy of at least 3 months.
• •9. If receiving glucocorticoid therapy, the dose must be stable over at least 7 days prior to study enrollment.
• •10. Archived tumor tissue available for central review.
• •11. Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
• •12. Baseline MRI performed within 14 days before starting study treatment, while on a stable glucocorticoid dose for at least 5 days before and during the imaging study.
• •13. Adequate hematologic, renal and hepatic function, as defined by:
• •Absolute neutrophil count (ANC) ≥ 1.5 109/L Platelet count ≥ 100 109/L Hemoglobin ≥ 90 g/L International normalized ratio (INR) and activated partial thromboplastin time (APTT) \< 1.5 upper limit of normal (ULN) Plasma creatinine\< 1.5 ULN Total bilirubin within normal limits (\< 2.5 ULN if Gilbert's syndrome) AST and ALT \< 2.5 ULN
• •14. Patients who are women of childbearing potential or men (unless vasectomised) must agree to use a highly-effective method of birth control, such as hormonal contraceptive implants, combined oral contraceptives, an intrauterine device, a double-barrier method (eg. condom with a diaphragm) or abstinence, from study entry until 4 months after completing study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• •15. Ability to understand and the willingness to sign a written informed consent document.