A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM

Eligibility Criteria

• 1. Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme.
• 2. Treatment plan includes 60 Gy of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
• 3. 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).
• 4. Aged 18 years and older.
• 5. Karnofsky Performance Status ≥ 70
• 6. Life expectancy of at least 3 months.
• 7. Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
• 8. Baseline MRI performed within 7 days before starting study treatment while on a stable or decreasing glucocorticoid dose for at least 7 days before and during the imaging study.
• 9. Adequate hematologic, renal and hepatic function, as defined by:
• 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• 2. Platelet count ≥ 75 x 109/L
• 3. Hemoglobin ≥ 10.0 g/dl
• 4. Serum creatinine \< 1.5 x ULN
• 5. Total bilirubin within normal limits (≤ 2.5 x ULN if Gilbert's syndrome)
• 6. Aspartate transaminase (AST) and Alanine transaminase (ALT) \< 2.5 x ULN
• 10. Women of childbearing potential or men with child-bearing potential partners (unless vasectomized) must agree to use a highly-effective method of birth control from study entry until 4 months after completing study therapy.
• 11. Ability to understand and the willingness to sign a written informed consent document.
• 1. Recurrent Glioblastoma
• 2. Prior treatment for glioblastoma apart from surgical resection.
• 3. Presence of multi-focal glioblastoma disease that cannot be encompassed into a radiation treatment field that would be safely treated to the prescribed radiation dose.
• 4. Presence of leptomeningeal disease that cannot be encompassed within a feasible and safe radiation field.
• 5. Intracranial bleeding, except for stable grade 1 hemorrhage or a post-operative bleed that is clearing.
• 6. Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
• 7. Subjects who have received any other investigational agent within 4 weeks before enrollment
• 8. Stroke or transient ischemic attack requiring hospitalization within 6 months before enrollment.
• 9. Myocardial infarction (MI) within 6 months before enrolment, unstable angina, New York Heart Association (NYHA) class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP \> 160 mmHg and/or diastolic BP \> 100 mmHg).
• 10. Known History of Congenital long QT syndrome (12-lead EKG is not required).
• 11. Clinically significant chronic obstructive pulmonary disease or asthma.
• 12. Active major infection requiring treatment.
• 13. A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancers or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
• 14. Known infection with human immunodeficiency virus or hepatitis B or C virus (testing is not required).
• 15. Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins, low-dose aspirin, rivaroxaban (Xarelto®), apixaban (Eliquis®), or dabigatran (Pradaxa®).
• 16. History of allergic reactions attributed to compounds of similar chemical composition to NanO2.
• 17. Women who are pregnant or breast feeding.
• 18. Inability to comply with study procedures.
• 19. History or evidence of any other clinically significant condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with study procedures, evaluation or completion.
• 20. Known hypersensitivity to any temozolomide component or to dacarbazine (DTIC).