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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00919737
First received: June 10, 2009
Last updated: October 29, 2013
Last verified: October 2013
  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.

Resource links provided by NLM:


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 ]

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%

  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
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 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: October 29, 2013
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 July 31, 2014