UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of photodynamic therapy (PDT) for malignant meningioma
Acronym	PDT for malignant meningioma
Scientific Title	Phase II study of photodynamic therapy (PDT) for malignant meningioma
Scientific Title:Acronym	PDT for malignant meningioma
Region	Japan

Condition
Condition	malignant/atypical meningioma
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the safety and efficacy of photodynamic therapy in the treatment of malignant meningioma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free time of the laser irradiation site
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(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
Key exclusion criteria	(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.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name KOHMURA EIJI
Organization	Kobe Graduate School of Medicine
Division name	Neurosurgery
Zip code
Address	Kusunoki-Cho 7-5-2 Chuou-ku
TEL	0783825966
Email	ekohmura@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name SASAYAMA TAKASHI
Organization	Kobe University Hospital
Division name	Neurosurgery
Zip code
Address	Kusunoki-Cho 7-5-2 Chuou-ku
TEL	0783825966
Homepage URL
Email	takasasa@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 22 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 05 Day
Last modified on	2020 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034223