Back to resultsStudy of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
Primary Purpose
Malignant Glioma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
NPC-08
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Glioma focused on measuring NPC-08, carmustine, nitrosourea, safety
Eligibility 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;
Sites / Locations
- The Tazuke Kofukai Foundation Medical Research Kitano Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NPC-08
Arm Description
Outcomes
Primary Outcome Measures
Overall survival to 12 months
Secondary Outcome Measures
Progression-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00919737
Brief Title
Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobelpharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
NPC-08, carmustine, nitrosourea, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPC-08
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NPC-08
Intervention Description
Polifeprosan 20 with Carmustine 3.85%
Primary Outcome Measure Information:
Title
Overall survival to 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masao Mastutani, M.D., D.M.Sci.
Organizational Affiliation
Saitama International Medical Center, Saitama Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Tazuke Kofukai Foundation Medical Research Kitano Hospital
City
Osaka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
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