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

Nobelpharma Co., Ltd.

Status and phase

Completed

Phase 2

Phase 1

Conditions

Malignant Glioma

Treatments

Drug: NPC-08

Study type

Interventional

Funder types

Industry

Identifiers

NCT00919737

NPC-08-1

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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;