UMIN-CTR Clinical Trial

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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