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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00919737
First received: June 10, 2009
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Malignant Glioma
 Drug: NPC-08
 Phase 1
Phase 2

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

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Overall survival to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: June 2009
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC-08 Drug: NPC-08
Polifeprosan 20 with Carmustine 3.85%

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919737

Locations
Japan
The Tazuke Kofukai Foundation Medical Research Kitano Hospital
Osaka, Japan
Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Masao Mastutani, M.D., D.M.Sci. Saitama International Medical Center, Saitama Medical University
  More Information

No publications provided

Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT00919737     History of Changes
Other Study ID Numbers: NPC-08-1
Study First Received: June 10, 2009
Last Updated: April 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nobelpharma:
NPC-08
carmustine
nitrosourea
safety

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 21, 2013