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

A Phase 1/2, Multicenter, Non-Randomized, Open Label Clinical Trial of NPC-08 Implant in Patients Undergoing Surgery for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00919737

Enrollment

Registered

2009-06-12

Start date

2009-06-30

Completion date

2011-04-30

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Glioma

Keywords

NPC-08, carmustine, nitrosourea, safety

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.

Interventions

DRUGNPC-08

Polifeprosan 20 with Carmustine 3.85%

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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;

Design outcomes

Primary

Measure	Time frame
Overall survival to 12 months	12 months

Secondary

Measure	Time frame
Progression-free survival	12 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026