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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nobelpharma
• Treatments: Carmustine

Criteria

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;