UMIN-CTR Clinical Trial

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

Recurrent glioblastoma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Safety
-Spectrum and frequency of adverse events

Key secondary outcomes

Efficacy
-Change in tumor size on MRI
-Progression free survival
-Overall survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

(1) The University of Tokyo Hospital
(2) The IMSUT Hospital

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2009

Year

10

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2009

Year

10

Month

23

Day

Last modified on

2019

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003240