Status:
COMPLETED
Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
Lead Sponsor:
Nobelpharma
Conditions:
Malignant Glioma
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00919737
Start Date
June 1 2009
End Date
April 1 2011
Last Update
October 30 2013
Active Locations (1)
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1
The Tazuke Kofukai Foundation Medical Research Kitano Hospital
Osaka, Osaka, Japan