Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) With Concomitant Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM)

Inclusion Criteria:

• Aged at least 18 years of age; male or female. A patient who is 70 years of age or older may be considered for enrollment after review of patient clinical and laboratory data by the Protocol Medical Monitor.
• Histologically confirmed diagnosis of GBM.
• Contrast enhancing disease on MRI within 21 days prior to Screening.
• Karnofsky score (KPS) of ≥ 60 at Screening.
• No prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
• Within 2 weeks of Baseline visit, hematologic and renal functions as specified: Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.0g/dL, creatinine ≤ 1.7mg/dl, total bilirubin ≤ 1.5mg/dL, blood urea nitrogen (BUN) within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm.
• Sexually active patients must use an acceptable method of contraception while receiving doses of study medication.
• Females of childbearing potential must have a negative serum or urine pregnancy test at Screening and have additional pregnancy tests during study.

Exclusion Criteria:

• Pt. who cannot undergo MRI.
• Pregnant or lactating.
• Serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety.
• Pt. receiving concurrent chemotherapeutics or investigational agents within 30 days of Baseline assessments, including gliadel wafers or gliasite application.