Unique ID issued by UMIN | UMIN000031156 |
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Receipt number | R000034223 |
Scientific Title | Phase II study of photodynamic therapy (PDT) for malignant meningioma |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2020/07/06 12:18:58 |
Phase II study of photodynamic therapy (PDT) for malignant meningioma
PDT for malignant meningioma
Phase II study of photodynamic therapy (PDT) for malignant meningioma
PDT for malignant meningioma
Japan |
malignant/atypical meningioma
Neurosurgery |
Malignancy
NO
The objective of this study is to evaluate the safety and efficacy of photodynamic therapy in the treatment of malignant meningioma.
Safety,Efficacy
Exploratory
Others
Phase II
Progression free time of the laser irradiation site
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Device,equipment |
1) The patient is over 20 year old, who has
grade 2 or 3 recurrent meningioma, or is diagnosed with grade 2 or 3 meningioma in initial surgery and need additional resection.
2) A single intravenous injection of talaporfin sodium (40 mg/m2) was administered 1 day before resection of the tumor. The next day after completion of the tumor removal, the residual lesion and/or resection cavity were irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure was performed 22-27 hours after drug administration. After PDT, the safety and efficacy of the PDT is evaluated by serial MRI study.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Hospital inpatients over the age of 20 years
(2) Patients who are diagnosed as primary or recurrent malignant meningioma (WHO grade 2 or 3), which needs resection.
(3) The tumor will be able to be subtotally removed.
(4) Residual tumor region will be able to be irradiated by laser.
(5) Laser irradiation site do not include large cerebral arteries.
(6) KPS>=60%
(7) Organ Function:
1. WBC>= 3,000 /micro L
2. Hb>=8.0 g/dL
3. Plt>=100,000 /micro L
4. AST (GOT) <=100 IU/L
5. ALT (GPT) <=100 IU/L
6. serum Cr <= 1.5 mg/dL
(8) Patients willing to participate in the trial and sign written informed consent
(1) Subject is known, suspected or has history of intolerance or allergy to Talaporfin Sodium.
(2) Subjects with porphyria.
(3) Severe liver and renal dysfunction.
(4) Subject with allergies such as a drug hypersensitivity constitution.
(5) Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study, as risks of fetal and teratogenic adverse effects of Talaporfin Sodiumare not known.
35
1st name | |
Middle name | |
Last name | KOHMURA EIJI |
Kobe Graduate School of Medicine
Neurosurgery
Kusunoki-Cho 7-5-2 Chuou-ku
0783825966
ekohmura@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | SASAYAMA TAKASHI |
Kobe University Hospital
Neurosurgery
Kusunoki-Cho 7-5-2 Chuou-ku
0783825966
takasasa@med.kobe-u.ac.jp
Kobe University Hospital
none
Self funding
NO
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Open public recruiting
2017 | Year | 11 | Month | 22 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 04 | Month | 01 | Day |
2028 | Year | 03 | Month | 31 | Day |
2018 | Year | 02 | Month | 05 | Day |
2020 | Year | 07 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034223
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