Study of Therapy With TransMID™ Compared to Best Standard of Care in Patients With Glioblastoma Multiforme

Exclusion Criteria

• •1\) Anticipated life expectancy of less than 3 months 2 Infratentorial or intraventricular tumors 3) Presence of satellite tumors 4) Chemotherapy within 30 days prior to study entry or nitrosoureas or Mitomycin-C containing therapy within 42 days prior to study entry 5) External Beam irradiation within 60 days prior to study entry or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry 6) Tumor surgery, tumor debulking or other neurosurgery within 5 days prior to study entry 7) Previous administration of TransMID™ 8) Previous enrollment in this study 9) Regional therapy including administration of biodegradable polymer wafers containing carmustine within 90 days prior to study entry or brachytherapy within 12 calendar months prior to study entry 10) Significant liver function impairment - AST or ALT \> 2 times the upper limit of normal, total bilirubin \> upper limit of normal 11) Hepatitis B surface antigen positive or positive Anti-Hepatitis C antibodies, or previous history of infectious Hepatitis (except previous Hepatitis A infection) 12) Significant renal impairment (serum creatinine \> 1.7 mg/dL or 150 µmol/L) 13) Coagulopathy (prothrombin time \[PT\] or activated partial thromboplastin time \[APTT\] \>1.5 times control) 14) Thrombocytopenia (platelet count \< 100 x 103/μL or 100 x 109/L) 15) Granulocytopenia (absolute neutrophil count (ANC), \< 1 x 103/μL or 1.0 x 109/L) 16) Severe acute infection 17) Medical condition that is considered an unacceptable anesthetic risk 18) Evidence of a mass effect on CT or MRI with more than a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness or clinically significant papilledema 19) Nursing or pregnant females. A pregnancy test will be performed on all females who are of child-bearing potential 20) Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry