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 |
A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive malignant pleural mesothelioma
A clinical study of G47delta oncolytic virus therapy for progressive malignant pleural mesothelioma
A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive malignant pleural mesothelioma
A clinical study of G47delta oncolytic virus therapy for progressive malignant pleural mesothelioma
Japan |
Malignant pleural mesothelioma
Chest surgery |
Malignancy
NO
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.
Safety
Phase I
Safety
-Spectrum and frequency of adverse events
Efficacy
-Change in tumor size on CT scan
-Progression free survival
-Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
-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
-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
6
1st name | Tomoki |
Middle name | |
Last name | Todo |
IMSUT Hospital, The University of Tokyo
Department of Surgical Neuro-oncology
1088639
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
03-5449-5462
dctsm@ims.u-tokyo.ac.jp
1st name | Fumitaka |
Middle name | |
Last name | Nagamura |
IMSUT Hospital, The University of Tokyo
Center for Translational Research
1088639
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
03-5449-5462
http://www.ims.u-tokyo.ac.jp/glioma/research/form_mesothelioma/index.html
dctsm@ims.u-tokyo.ac.jp
IMSUT Hospital, The University of Tokyo
Japan Agency for Medical Research and Development
IMSUT Hospital, The University of Tokyo
Japanese Governmental office
Japan
The University of Tokyo, Clinical Research Review Board
7-3-1, Hongo,Bunkyo-ku,Tokyo, Tokyo
0358410818
mgr-ohrs@m.u-tokyo.ac.jp
NO
東京大学医科学研究所附属病院(東京都)IMSUT Hospital, The University of Tokyo (Tokyo)
2018 | Year | 09 | Month | 07 | Day |
Unpublished
6
Completed
2018 | Year | 02 | Month | 15 | Day |
2018 | Year | 07 | Month | 04 | Day |
2018 | Year | 09 | Month | 01 | Day |
2023 | Year | 03 | Month | 27 | Day |
2024 | Year | 02 | Month | 22 | Day |
2023 | Year | 12 | Month | 12 | Day |
2018 | Year | 09 | Month | 07 | Day |
2024 | Year | 03 | Month | 12 | Day |
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 | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |