UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034063 |
|---|---|
| Receipt number | 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 | 2024/03/12 09:38:37 |
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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
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
dctsm@ims.u-tokyo.ac.jp
Sponsor or person
Institute
IMSUT Hospital, The University of Tokyo
Institute
Department
Personal name
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
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
6
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
Completed
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
| 2024 | Year | 02 | Month | 22 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038588
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
