Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme

Inclusion criteria

• Male or female, aged between 18 and 65 years;
• Radiographic evidence on cranial MRI of a single contrast-enhancing unilateral supratentorial cerebral tumor;
• Karnofsky Performance Score of 60 or higher;
• Willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery;

Exclusion criteria

• More than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial MRI scan;
• Prior radiotherapy to the brain;
• Prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents;
• Known hypersensitivity to nitrosoureas;
• Participation in any other investigational protocol in the previous 6 months for any type of malignancy;