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

NCT ID: NCT00919737

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-04-30

Brief Summary

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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

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Conditions

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Malignant Glioma

Keywords

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NPC-08 carmustine nitrosourea safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NPC-08

Group Type EXPERIMENTAL

NPC-08

Intervention Type DRUG

Polifeprosan 20 with Carmustine 3.85%

Interventions

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NPC-08

Polifeprosan 20 with Carmustine 3.85%

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nobelpharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Masao Mastutani, M.D., D.M.Sci.

Role: STUDY_DIRECTOR

Saitama International Medical Center, Saitama Medical University

Locations

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The Tazuke Kofukai Foundation Medical Research Kitano Hospital

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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NPC-08-1

Identifier Type: -

Identifier Source: org_study_id