Unique ID issued by UMIN | UMIN000011636 |
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Receipt number | R000013555 |
Scientific Title | A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive olfactory neuroblastoma |
Date of disclosure of the study information | 2013/09/04 |
Last modified on | 2020/08/27 18:37:38 |
A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive olfactory neuroblastoma
A clinical study of G47delta oncolytic virus therapy for progressive olfactory neuroblastoma
A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive olfactory neuroblastoma
A clinical study of G47delta oncolytic virus therapy for progressive olfactory neuroblastoma
Japan |
Recurrent olfactory neuroblastoma
Oto-rhino-laryngology | Neurosurgery |
Malignancy
NO
Primary: To assess the safety of G47delta administered into the tumor in subjects with recurrent or progressive olfactory neuroblastoma.
Secondary: To assess the efficacy of G47delta by tumor size on MRI, etc.
Safety
Safety
-Spectrum and frequency of adverse events
Efficacy
-Change in tumor size on MRI
-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 study. A replication-competent, recombinant herpes simplex virus type 1 (G47delta) will be administered into the tumor of patients with recurrent or progressive olfactory neuroblastoma. The assigned dose will be administered to 10 subjects. The same dose of G47delta will be inoculated to the remaining tumor every 4 weeks.
18 | years-old | <= |
Not applicable |
Male and Female
-Histologically confirmed recurrent olfactory neuroblastoma that is progressive despite previous or ongoing radiation therapy. Subjects with and without distant metastases will be included.
-Enhancing lesion measures 1.0 cm or larger in diameter on contrast-enhanced MRI within 14 of G47delta administration
-Performance Status(PS) = 0 to 2
-Age >= 18 years
-Steroids regimen stable for at least 1 week prior to G47delta administration
-Willing to use effective barrier birth control for at least 6 months after G47delta administration
-Expected survival >= 3 months
-Ability to give informed consent
-Known HIV seropositivity
-History of alcohol or other drug abuse
-Any contraindication for undergoing gadolinium contrast enhanced MRI such as: individuals with pacemakers, infusion pumps, or allergy to MRI contrast media
-History or current diagnosis of any medical or psychological condition that might interfere with the subject's ability to participate
-Evidence of active herpes infection
-Requires antiviral therapy for HSV at baseline
-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
-Blood test results outside protocol specified limits
-Allergy to anti-HSV drug (acyclovir)
-Administration of other clinical study drugs within 30 days of G47delta administration
-Any vaccination within 30 days of G47delta administration
-Tumor resection 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
10
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
0364092145
mntanaka-nsu@umin.ac.jp
1st name | Division of Clinical Trial Safety Management |
Middle name | |
Last name | Division of Clinical Trial Safety Management |
IMSUT Hospital, The University of Tokyo
Division of Clinical Trial Safety Management
1120011
Bunkyo-ku
09035151961
mntanaka-nsu@umin.ac.jp
IMSUT Hospital, The University of Tokyo
The Ministry of Education, Science, Sports and Culture
IMSUT Hospital, The University of Tokyo
Japanese Governmental office
The University of Tokyo, Clinical Research Review Board
7-3-1, Hongo,Bunkyo-ku,Tokyo, Tokyo
03-5841-0818
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)
2013 | Year | 09 | Month | 04 | Day |
Unpublished
Open public recruiting
2013 | Year | 06 | Month | 28 | Day |
2013 | Year | 05 | Month | 31 | Day |
2013 | Year | 09 | Month | 06 | Day |
2028 | Year | 06 | Month | 27 | Day |
2013 | Year | 09 | Month | 03 | Day |
2020 | Year | 08 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013555
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