MBM-02 (Tempol) for the Treatment of Glioblastoma Multiforme (GBM)

Inclusion Criteria

• •1. Be \> 35 and ≤ 75 years of age;
• •2. Be newly diagnosed with glioblastoma multiforme within 4 weeks of open biopsy/resection;
• •3. Be histologically confirmed to have definitive GBM by partial or complete surgical resection (i.e. not by biopsy only) within 4 weeks prior to MBM-02 administration;
• •4. Have recovered from the effects of surgery, post-operative infection, and other complications before study registration;
• •5. Have a diagnostic contrast-enhanced MRI or CT scan of the brain performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days prior to MBM-02 administration;
• •6. If female and of child bearing potential, must be using an effective birth-control method as described in section 3.5;
• •7. If a male with a female partner of child bearing potential, adequate methods of contraception must be employed as described in section 3.5.
• •8. If male, no sperm donation for 90 days until after the conclusion of the study;
• •9. Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
• •10. Be able to participate for the full term of the clinical investigation;
• •11. Have a Karnofsky performance status of \>70;
• •12. Have a life expectancy ≥ 6 months; and
• •13. Have adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
• •Hematology:
• •Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood
• •Hepatic:
• •Total bilirubin ≤ 2 x ULN Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2 x ULN
• •Renal:
• •creatinine clearance (CrCl) ≥ 60 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CrCl female = 0.85 x (CrCl male)