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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034063
Receipt No. R000038588
Scientific Title A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive malignant pleural mesothelioma
Date of disclosure of the study information 2018/09/07
Last modified on 2019/09/08

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Basic information
Public title A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive malignant pleural mesothelioma
Acronym A clinical study of G47delta oncolytic virus therapy for progressive malignant pleural mesothelioma
Scientific Title A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive malignant pleural mesothelioma
Scientific Title:Acronym A clinical study of G47delta oncolytic virus therapy for progressive malignant pleural mesothelioma
Region
Japan

Condition
Condition Malignant pleural mesothelioma
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Primary: To assess the safety of G47delta administered into the pleural cavity in subjects with progressive malignant pleural mesothelioma.
Secondary: To assess the efficacy of G47delta by tumor size on CT, etc.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety
-Spectrum and frequency of adverse events
Key secondary outcomes Efficacy
-Change in tumor size on CT scan
-Progression free survival
-Overall survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This clinical study is an open-label, single-armed, phase I study. A replication-competent, recombinant herpes simplex virus type 1 (G47delta) will be administered into the pleural cavity of patients with inoperable, recurrent or progressive malignant pleural mesothelioma. A fixed dose of G47delta will be administered into the pleural cavity every 4 weeks, maximum 6 times.
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 -Histologically confirmed malignant pleural mesothelioma that is inoperable, recurrent or progressive.
-No prior thoracotomy or thoracoscopic surgery, except for biopsy.
-History of chemotherapy or radiotherapy is irrelative.
-Presence of one or more evaluable lesions on contrast-enhanced CT scan within 14 days of G47delta administration
-Interval of 4 weeks or more from prior chemotherapy
- Performance Scale (PS) = 0 to 1
-Age >= 20 years
-Willing to use effective barrier birth control for at least 6 months after G47delta administration
-Expected survival >= 3 months
-Sufficient major organ functions
-Laboratory test results meet the following criteria
A) White blood cell count>2000/mm3, Absolute neutrophil count (ANC)>1000 /mm3, Platelets>60000 /mm3, Hemoglobin>9.0 g/dL
B) Prothrombin time-international normalized ratio <= 1.3 times the upper limit of facility reference value
C) Serum creatinine<1.7mg/dL
D) AST and ALT <= 4 times the upper limit of facility reference value
E) Total bilirubin<=1.5 mg/dL
Key exclusion criteria -Known HIV seropositivity
-Any contraindication for undergoing iodine contrast enhanced CT scan
-Insufficient space in the pleural cavity to inject G47delta
-Evidence of active herpes infection or requires antiviral therapy for HSV
-Active and uncontrolled infection
-History of myocardial infarction within 3 months
-Uncontrolled or severe medical condition such as heart failure,
angina pectoris, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, and autoimmune disease
-History of alcohol or other drug dependency.
- Active double cancer
-Allergy to anti-HSV drug
-Administration of other clinical study drugs or research treatments within 30 days of G47delta administration
-Prior gene therapy or oncolytic virus therapy other than G47delta
-Pregnant or nursing females
-Conditions considered inadequate for the subject to be enrolled in the study
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Tomoki
Middle name
Last name Todo
Organization IMSUT Hospital, The University of Tokyo
Division name Department of Surgical Neuro-oncology
Zip code 1088639
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL 03-5449-5462
Email dctsm@ims.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Fumitaka
Middle name
Last name Nagamura
Organization IMSUT Hospital, The University of Tokyo
Division name Center for Translational Research
Zip code 1088639
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL 03-5449-5462
Homepage URL http://www.ims.u-tokyo.ac.jp/glioma/research/form_mesothelioma/index.html
Email dctsm@ims.u-tokyo.ac.jp

Sponsor
Institute IMSUT Hospital, The University of Tokyo
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
IMSUT Hospital, The University of Tokyo
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization The University of Tokyo, Clinical Research Review Board
Address 7-3-1, Hongo,Bunkyo-ku,Tokyo, Tokyo
Tel 0358410818
Email mgr-ohrs@m.u-tokyo.ac.jp

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 東京大学医科学研究所附属病院(東京都)IMSUT Hospital, The University of Tokyo (Tokyo)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 07 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
2018 Year 02 Month 15 Day
Date of IRB
2018 Year 07 Month 04 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2023 Year 03 Month 27 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 09 Month 07 Day
Last modified on
2019 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038588

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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