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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Malignant pleural mesothelioma | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 6 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
Registered date |
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Last modified on |
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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 |