UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011636
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

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Basic information

Public title

A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive olfactory neuroblastoma

Acronym

A clinical study of G47delta oncolytic virus therapy for progressive olfactory neuroblastoma

Scientific Title

A clinical study of a replication-competent, recombinant herpes simplex virus type 1 (G47delta) in patients with progressive olfactory neuroblastoma

Scientific Title:Acronym

A clinical study of G47delta oncolytic virus therapy for progressive olfactory neuroblastoma

Region

Japan


Condition

Condition

Recurrent olfactory neuroblastoma

Classification by specialty

Oto-rhino-laryngology Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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.

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 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.

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 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

Key exclusion criteria

-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

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Tomoki
Middle name
Last name Todo

Organization

IMSUT Hospital, The University of Tokyo

Division name

Department of Surgical Neuro-oncology

Zip code

1088639

Address

4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan

TEL

0364092145

Email

mntanaka-nsu@umin.ac.jp


Public contact

Name of contact person

1st name Division of Clinical Trial Safety Management
Middle name
Last name Division of Clinical Trial Safety Management

Organization

IMSUT Hospital, The University of Tokyo

Division name

Division of Clinical Trial Safety Management

Zip code

1120011

Address

Bunkyo-ku

TEL

09035151961

Homepage URL


Email

mntanaka-nsu@umin.ac.jp


Sponsor or person

Institute

IMSUT Hospital, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Science, Sports and Culture
IMSUT Hospital, The University of Tokyo

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

The University of Tokyo, Clinical Research Review Board

Address

7-3-1, Hongo,Bunkyo-ku,Tokyo, Tokyo

Tel

03-5841-0818

Email

mgr-ohrs@m.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

2013 Year 09 Month 04 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

Open public recruiting

Date of protocol fixation

2013 Year 06 Month 28 Day

Date of IRB

2013 Year 05 Month 31 Day

Anticipated trial start date

2013 Year 09 Month 06 Day

Last follow-up date

2028 Year 06 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 03 Day

Last modified on

2020 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013555


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name