Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
- Registration Number
- NCT00919737
- Lead Sponsor
- Nobelpharma
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NPC-08 NPC-08 -
- Primary Outcome Measures
Name Time Method Overall survival to 12 months 12 months
- Secondary Outcome Measures
Name Time Method Progression-free survival 12 months
Trial Locations
- Locations (1)
The Tazuke Kofukai Foundation Medical Research Kitano Hospital
🇯🇵Osaka, Japan