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

A Phase 1/2, Multicenter, Non-Randomized, Open Label Clinical Trial of NPC-08 Implant in Patients Undergoing Surgery for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme.

The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the treatment of 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;