Overview

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;