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

Malignant Glioma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919737
• Other study ID #: NPC-08-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 10, 2009
• Last updated: October 29, 2013
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: October 2013
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Malignant Glioma

Intervention

Drug:
• NPC-08
Polifeprosan 20 with Carmustine 3.85%

Locations

Country	Name	City	State
Japan	The Tazuke Kofukai Foundation Medical Research Kitano Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival to 12 months		12 months	Yes
Secondary	Progression-free survival		12 months	Yes