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

This study has been completed.
Information provided by (Responsible Party):
Nobelpharma Identifier:
First received: June 10, 2009
Last updated: October 29, 2013
Last verified: October 2013
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
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.

Resource links provided by NLM:

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Overall survival to 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ]

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


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00919737

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

Responsible Party: Nobelpharma Identifier: NCT00919737     History of Changes
Other Study ID Numbers: NPC-08-1
Study First Received: June 10, 2009
Last Updated: October 29, 2013

Keywords provided by Nobelpharma:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on June 22, 2017