UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive glioblastoma
Acronym	A clinical study of G47delta oncolytic virus therapy for progressive glioblastoma
Scientific Title	A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive glioblastoma
Scientific Title:Acronym	A clinical study of G47delta oncolytic virus therapy for progressive glioblastoma
Region	Japan

Condition
Condition	Recurrent glioblastoma
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Primary: To assess the safety of G47delta administered into the tumor of the brain in subjects with recurrent or progressive glioblastoma. Secondary: To assess the efficacy of G47delta by tumor size on MRI, etc.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety -Spectrum and frequency of adverse events
Key secondary outcomes	Efficacy -Change in tumor size on MRI -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	Medicine
Interventions/Control_1	This clinical study is an open-label, single-armed, phase I-II study. Three cohorts of 3 subjects each are planned in a dose escalation phase, and 12 additional subjects will be treated at the highest safe dose. A replication-competent, recombinant herpes simplex virus type 1 (G47delta) will be administered stereotactically into the tumor of patients with recurrent or progressive glioblastoma. The assigned dose will be equally divided and inoculated into 2 to 5 different coordinates. Five to 14 days later, the same dose of G47delta will be inoculated stereotactically into the same coordinates.
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 recurrent glioblastoma that is progressive despite previous or ongoing radiation therapy -Enhancing lesion measures 1.0 cm or larger in diameter on contrast-enhanced MRI within 14 days of G47delta administration -Karnofsky Performance Scale(KPS) >= 70% -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
Key exclusion criteria	-Previous history or current diagnosis of other cancer except curative cervical cancer in-situ or basal or squamous cell carcinoma of the skin -Previous history of encephalitis, multiple sclerosis or other CNS infection -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 -Documented extracranial metastases -Multiple intracranial malignant glioma lesions -Tumor involvement that would require ventricular, brainstem, or posterior fossa inoculation or access through a ventricle in order to deliver the study drug -Subependymal or subarachnoidal dissemination -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 -Immunotherapy (e.g., interferon) within 6 weeks of G47delta administration -Any vaccination 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 -Prior history of G47delta treatment or registration to G47delta clinical study -Pregnant or nursing females -Conditions considered inadequate for the subject to be enrolled in the study
Target sample size	21

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Tomoki Todo
Organization	(1) The University of Tokyo Hospital (2) The IMSUT Hospital
Division name	(1) Department of Neurosurgery (2) Department of Surgical Neuro-oncology
Zip code
Address	(1) 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan (2) 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name
Organization	(1) The University of Tokyo Hospital (2) The IMSUT Hospital
Division name	(1) Translational Research Center (2) Division of Clinical Trial Safety Management
Zip code
Address	(1) 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan (2) 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL	(1)03-5800-9072(2)03-5449-5462
Homepage URL	http://trac.umin.jp/hospital/ct/G47Delta.html
Email	TRC@h.u-tokyo.ac.jp

Sponsor
Institute	(1) The University of Tokyo Hospital (2) The IMSUT Hospital
Institute
Department

Funding Source
Organization	The Ministry of Education, Science, Sports and Culture The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	東京大学医学部附属病院（東京都） 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	2009 Year 10 Month 23 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	2009 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date	2009 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 10 Month 23 Day
Last modified on	2019 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003240