Unique ID issued by UMIN | UMIN000015995 |
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Receipt number | R000018598 |
Scientific Title | A phase 2 clinical trial of a replication-competent, recombinant herpes simplex virus type 1 in patients with glioblastoma |
Date of disclosure of the study information | 2014/12/18 |
Last modified on | 2020/06/26 15:57:00 |
A phase 2 clinical trial of a replication-competent, recombinant herpes simplex virus type 1 in patients with glioblastoma
A phase 2 clinical trial of HSV-1 oncolytic virus therapy for glioblastoma
A phase 2 clinical trial of a replication-competent, recombinant herpes simplex virus type 1 in patients with glioblastoma
A phase 2 clinical trial of HSV-1 oncolytic virus therapy for glioblastoma
Japan |
Residual or recurrent glioblastoma
Neurosurgery |
Malignancy
NO
To assess the efficacy and safety of G47delta administered into the tumor of the brain in subjects with residual or recurrent glioblastoma despite previous radiation therapy and TMZ chemotherapy.
Safety,Efficacy
Efficacy
- One year survival ratio
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Test drug will be administered stereotactically into the tumor of patients with residual or recurrent glioblastoma. The assigned dose will be repeatedly inoculated into the tumor no more than 6 times, with an interval of 7 (5 - 14) days between the 1st and 2nd administration, and every 4 weeks thereafter.
18 | years-old | <= |
Not applicable |
Male and Female
-Histologically confirmed residual or recurrent glioblastoma despite previous radiation therapy and TMZ chemotherapy.
-Enhancing lesion measures 1.0 cm or larger in diameter on contrast-enhanced MRI within 14 days of eligibility evaluation.
-Karnofsky Performance Scale(KPS) >= 60%
-Age >= 18 years
-Steroids regimen stable for at least 1 week prior to eligibility evaluation.
-Willing to use effective barrier birth control until at least 6 months after final G47delta administration
-Expected survival >= 3 months
-Previous history of encephalitis, multiple sclerosis or other CNS infection
-Known HIV seropositivity
-Any contraindication for undergoing gadolinium contrast enhanced MRI such as: individuals with pacemakers, infusion pumps, or allergy to MRI contrast media
-Documented extracranial metastases
-Multiple intracranial malignant glioma lesions
-Tumor in ventricular system, brainstem, or posterior fossa
-Subependymal or subarachnoidal dissemination
-Evidence of active herpes infection
-Requires antiviral therapy for HSV
-Active uncontrolled infection that precludes surgery
-Uncontrolled or severe medical condition such as heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, and autoimmune disease
-Alcohol or other drug abuse
-Blood test results outside protocol specified limits
-Current diagnosis of active cancers
-Allergy to anti-HSV drug (acyclovir)
-Administration of other clinical study drugs within 30 days of G47delta administration
-Brain tumor resection within 30 days of G47delta administration
-Prior gene therapy or oncolytic virus therapy other than G47delta
-Use of bevacizumab within 30 days of G47delta administration
-Pregnant or nursing females
-Conditions considered inadequate for the subject to be enrolled in the study
30
1st name | Tomoki |
Middle name | |
Last name | Todo |
The IMSUT Hospital
Department of Surgical Neuro-oncology
108-8639
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
03-5449-5462
dctsm@ims.u-tokyo.ac.jp
1st name | Center for Translational Research |
Middle name | |
Last name | Center for Translational Research |
The IMSUT Hospital
Center for Translational Research
108-8639
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
03-5449-5462
http://www.ims.u-tokyo.ac.jp/glioma/research/form3/
dctsm@ims.u-tokyo.ac.jp
The IMSUT Hospital
The Ministry of Education, Science, Sports and Culture
The Ministry of Health, Labour and Welfare
Japanese Governmental office
IMSUT hospital, Institutional Revew Boad
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
03-3443-8111
ken-jo@ims.u-tokyo.ac.jp
NO
東京大学医科学研究所附属病院(東京都)
2014 | Year | 12 | Month | 18 | Day |
Unpublished
Completed
2014 | Year | 08 | Month | 18 | Day |
2014 | Year | 08 | Month | 29 | Day |
2014 | Year | 12 | Month | 18 | Day |
2020 | Year | 04 | Month | 06 | Day |
2014 | Year | 12 | Month | 18 | Day |
2020 | Year | 06 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018598
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