UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031156
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

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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 or person

Institute

Kobe University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034223


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name