UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015995 |
|---|---|
| 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 |
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Basic information
Public title
A phase 2 clinical trial of a replication-competent, recombinant herpes simplex virus type 1 in patients with glioblastoma
Acronym
A phase 2 clinical trial of HSV-1 oncolytic virus therapy for glioblastoma
Scientific Title
A phase 2 clinical trial of a replication-competent, recombinant herpes simplex virus type 1 in patients with glioblastoma
Scientific Title:Acronym
A phase 2 clinical trial of HSV-1 oncolytic virus therapy for glioblastoma
Region
| Japan |
Condition
Condition
Residual or recurrent glioblastoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
- One year survival ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-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
Key exclusion criteria
-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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Todo |
Organization
The IMSUT Hospital
Division name
Department of Surgical Neuro-oncology
Zip code
108-8639
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 | Center for Translational Research |
| Middle name | |
| Last name | Center for Translational Research |
Organization
The IMSUT Hospital
Division name
Center for Translational Research
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL
03-5449-5462
Homepage URL
http://www.ims.u-tokyo.ac.jp/glioma/research/form3/
dctsm@ims.u-tokyo.ac.jp
Sponsor or person
Institute
The IMSUT Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Science, Sports and Culture
The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IMSUT hospital, Institutional Revew Boad
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
Tel
03-3443-8111
ken-jo@ims.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）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 18 | 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
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
| 2014 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 18 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018598
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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