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Last update:2019-03-18
 
|Essential information|
An open-label study of photodynamic therapy with ME2906 and PNL6405CNS in patients with malignant brain tumor 
Trial status Completed 
JMACCT ID JMA-IIA00026  Date JMACCT ID assigned 2009-03-19 
Recruitment status Completed  Trial phas 2 
Trial Type INTERVENTIONAL / SAFETY, EFFICACY  Trial Design Open-label, multicenter study 
Condition or Problem  Malignant brain tumor  Countries of Recruitment Japan 
 

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●Trial Title
Public title An open-label study of photodynamic therapy with ME2906 and PNL6405CNS in patients with malignant brain tumor 
Scientific title An open-label study of photodynamic therapy with ME2906 and PNL6405CNS in patients with malignant brain tumor 
Title acronym ME2906-BT-1 
 

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●Brief Description of Study
Brief summary  
 

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●Purpose
Primary objective To evaluate the efficacy and safety of photodynamic therapy (PDT) using a PDT photosensitizer (ME2906) and semiconductor laser equipment (PNL6405CNS) in patients with malignant brain tumor 
Secondary objective(s)  
 

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●Trial Design
Description of trial design Open-label, multicenter study 
Number of treatment arms 1  Type of control NONE 
Trial blinding schema OPEN LABEL  Randomized NO 
Randomization unit   Stratified randomization  
Dynamic randomization   Blocked randomization   
Method of allocation concealment  
 

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●Trial Phase
Trial phase 2 
 

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●Trial Type
Nature of investigation INTERVENTIONAL 
Type of trial SAFETY, EFFICACY 
Clinical trial for drug device development  
 

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●Health Condition(s) or Problem(s) Studied
Trial indication(s) Malignant brain tumor 
Background information For the past 20-odd years since photodynamic therapy (PDT) for brain tumors was first clinically studied in 1980, numerous studies have been conducted worldwide and produced favorable results. However, the combined use of a photosensitizer and laser equipment for brain tumors is yet to be approved by any regulatory authorities. Against this background, past study results of PDT with various photosensitizers and laser equipment, as well as the preliminary study results of ME2906 and PNL6405CNS have suggested great significance of pursuing the development of PDT employing ME2906 and PNL6405CNS as a new therapy for malignant brain tumors that show very poor response to current standard treatment. As part of the multidisciplinary treatment of malignant brain tumors, PDT offers high potential in improving treatment outcomes. This clinical trial was planned as an investigator-initiated trial intended to expand the application of PDT with ME2906 and PNL6405CNS to malignant brain tumors 
Does this study involve oncology? YES  Therapeutic area under study Neurosurgery 
Does this study involve collection of genetic information NO     
 

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●Interventions
Trial indication type TREATMENT  Intervention type DRUG 
      Study Intervention(s):
Name of intervention ME2906  Dose form / Japanese Medical Device Nomenclature INJECTION 
Route of administration / Site of application INTRAVENOUS BOLUS 
Dose per administration   
Dosing frequency / Frequency of use ONCE 
Planned duration of intervention  
Intended dose regimen 40 mg/m2 intravenous administration before surgery 
detailes of teratment arms  
Name of intervention   Dose form / Japanese Medical Device Nomenclature OTHER 
Route of administration / Site of application NOT APPLICABLE  
Dose per administration   
Dosing frequency / Frequency of use  
Planned duration of intervention  
Intended dose regimen After removal of the bulk of the tumor, the surgical cavity was irradiated by a 664 nm laser beam. 
detailes of teratment arms  
       Control Intervention(s):
Comparative
intervention name
  Dose form / Japanese Medical Device Nomenclature  
Route of administration / Site of application  
Dose per administration   
Dosing frequency / Frequency of use  
Planned duration of intervention  
Intended dose regimen  
 

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●Study Timeline
Date of protocol finalization 2008-12-15  Date of first ethics committee meeting 2009-01-09 
Date of first enrollment 2009-03-23  Study start date 2009-03-21 
Date of last follow-up 2012-02-28  Date of data entry closure 2012-05-14 
Data lock date 2012-05-14  Completion of data analysis 2012-05-22 
Study end date 2012-09-11     
 

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●Target sample size
Planned number of subjects  25 
Performed number of subjects   
 

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●Primary Outcome(s)
Primary outcome(s) Overall survival 
Timepoint(s)  
Primary outcome measure  
 

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●Key Secondary Outcome(s)
Secondary outcome(s) Progression-free survival, Response rate, etc. 
Timepoint(s)  
Secondary outcome measure  
 

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●Key Inclusion and Exclusion Criteria
Minimum age ≧20 YEARS  Maximum age ≦69 YEARS 
Sex of participants BOTH  Accepts healthy volunteers NO 
Inclusion criteria 1)Preoperative diagnostic imaging reveals the possibility of a primary malignant brain tumor
2)Patients suitable for tumor resection
3)Pretreatment MRI revealing that 50% or more of tumor mass is in supratentorial region
4)Pretreatment MRI revealing no tumor on optic nerve, olfactory nerve or pituitary gland
5)Pretreatment MRI revealing no dissemination
6)Patients themselves providing written consent to participation in the study
etc.
 
Exclusion criteria 1)Severe cardiovascular, blood, hepatic, gastrointestinal, renal, respiratory, endocrine, neurologic or psychiatric disorder
2)Serious bleeding or shock
3)Prone to bleeding
4)Serious infection
5)Pregnant or possibly pregnant women, or lactating women
6)Other patients judged by investigator or sub-investigator as inappropriate for the study
etc.
 
 

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●Trial Status
Recruitment status Completed 
Trial status Completed 
Reason for study stop  
 

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●Countries of Recruitment
Countrie(s) of recruitment Japan 
 

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●Sponsor
Primary sponsor Faculty of Advanced Techno-Surgery,Institute of Advanced Biomedical Engineering and Science,Tokyo Women's Medical University 
Secondary sponsor(s)  
 

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●Sources of Funding
Sources of funding Japan Medical Association 
Type of funding organization PUBLIC-INTEREST CORPORATION 
Country of funding sourc Japan 
 

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●Trial Institutions
Number of study sites 2 
Type of medical institution SPECIALTY CARE HOSPITAL or CLINIC 
Countrie(s) of Study Site(s) Japan 
Prefecture(s) of Study Site(s) Tokyo 
 

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●Contact for Public Queries
Contact name Hiroshi Iseki 
Contact organization Institute of Advanced Biomedical Engineering and Science,Tokyo Women's Medical University 
Department Faculty of Advanced Techno-Surgery 
Address 8-1, Kawadacho, Shinjuku, Tokyo 
TEL +81-3-5367-9945  FAX +81-3-5312-1844 
E-mail hiseki@abmes.twmu.ac.jp 
Study website http://www.twmu.ac.jp/LAB/FATS/index2.html 
 

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●Contact for Scientific Queries
Investigator name Hiroshi Iseki 
Investigator organization Institute of Advanced Biomedical Engineering and Science,Tokyo Women's Medical University 
Department Faculty of Advanced Techno-Surgery 
Address 8-1, Kawadacho, Shinjuku, Tokyo 
TEL +81-3-5367-9945  FAX +81-3-5312-1844 
E-mail  
 

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●Secondary IDs and Issuers
Secondary study ID   Issuer name  
 

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●Clinical Trial Notification (CTN) Reference Number
First CTN reference number 20-3824  Date of first CTN 2009-02-18 
 

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●Ethics Review
Approved by Ethics Committee YES 
Name of ethics committee  
Date of approved  
Address  
TEL  
FAX  
E-mail  
Website  
Committee approval number  
Reason for unapproval  
 

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●Publication of Study Results
Are the results published? YES 
Posted date  
Date of first publication  
Baseline characteristics  
Participant flow  
Protocol links  
Overall study design - description  
Efficacy conclusions  
Safety conclusions  
Discussion and overall conclusions  
Results links  
 

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●Sharing of Individual clinical trial participant-level data(IPD)
Results IPD Plan  
Results IPD Description  
 

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●Other Information
Other Information Muragaki Y, Akimoto J, Maruyama T, Iseki H, Ikuta S, Nitta M, et al. Phase II clinical study on intraoperative photodynamic therapy with talaporfin sodium and semiconductor laser in patients with malignant brain tumors. J Neurosurg 2013; 119(4): 845-52. 

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