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

Inclusion Criteria:

• Subjects must have histologically confirmed diagnosis of World Health Organization (WHO) grade III or IV malignant glioma

• Subjects must be planning to start standard of care radiation therapy andchemotherapy

• Subjects must be within 12 weeks of last major neurosurgical procedure for thehigh-grade glioma (craniotomy, open biopsy, or stereotactic biopsy)

• Subjects must have had a definitive resection with residual radiographic contrastenhancement on post-resection CT or MRI of less than or equal to 3 cm in any twoperpendicular planes on any images

• Age * 18 years

• Karnofsky Performance Status (KPS) ≥ 70%

• Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,500 cells/µl, platelets ≥ 125,000 cells/µl

• Serum creatinine ≤ 1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) andbilirubin ≤ 1.5 times upper limit of normal

• Signed informed consent approved by the Institutional Review Board

• If sexually active, patients must agree to use appropriate contraceptive measuresfor the duration of the study and for 12 months afterwards as stated in the informedconsent

• Stable and/or decreasing dose of corticosteroids for greater than or equal to 7days.

Exclusion Criteria:

• Pregnancy or breast-feeding

• Active infection requiring IV antibiotics 7 days before enrollment

• Signs of wound-healing problems or infection at the craniotomy/biopsy site.

• Prior, unrelated malignancy requiring current active treatment with the exception ofcervical carcinoma in situ and adequately treated basal cell or squamous cellcarcinoma of the skin

• Co-medication that may interfere with study results; e.g. immuno-suppressive agentsother than corticosteroids

• Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective ofthe grade of the tumor

• Evidence of > grade 1 CNS hemorrhage on baseline MRI on CT scan

• Systemic treatment with inducers or strong inhibitors of cytochrome P450 within fourdays before enrollment or planned treatment during the time period of the study.

• Metal in the body (except dental fillings) e.g., pacemaker, infusion pump, metalaneurysm clip, metal prosthesis, joint, rod or plate.

• Severe allergy to contrast agent.

• Inadequately controlled hypertension

• Active or history of postural hypotension and autonomic dysfunction

• Clinically significant (i.e. active) cardiovascular disease or cerebrovasculardisease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment,myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, NewYork Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), orserious cardiac arrhythmia uncontrolled by medication or potentially interferingwith protocol treatment

• History or evidence upon physical/neurological examination of central nervous systemdisease (e.g. seizures) unrelated to cancer unless adequately controlled bymedication or potentially interfering with protocol treatment

• Significant vascular disease (e.g., aortic aneurysm requiring surgical repair orrecent arterial thrombosis) within 6 months prior to start of study treatment

• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of aQTc interval >480 milliseconds (ms) (CTCAE grade 1)

• A known history of additional risk factors for Torsades de Pointes (TdP) (e.g.,congestive heart failure, hypokalemia, known family history of Long QT Syndrome).