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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.


Phase 1/Phase 2
18 Years
64 Years
Open (Enrolling)
Both
Malignant Glioma

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Trial Information

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.


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;

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival to 12 months

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Saitama International Medical Center, Saitama Medical University

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

NPC-08-1

NCT ID:

NCT00919737

Start Date:

June 2009

Completion Date:

September 2013

Related Keywords:

  • Malignant Glioma
  • NPC-08
  • carmustine
  • nitrosourea
  • safety
  • Glioblastoma
  • Glioma

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