UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007263
Receipt number R000008523
Scientific Title Phase I study of intratumoral injection of HF10, naturally occurring mutant of herpes simplex virus type 1
Date of disclosure of the study information 2012/02/10
Last modified on 2015/08/12 07:47:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase I study of intratumoral injection of HF10, naturally occurring mutant of herpes simplex virus type 1

Acronym

Intratumoral injection of naturally occurring mutant of HSV-1

Scientific Title

Phase I study of intratumoral injection of HF10, naturally occurring mutant of herpes simplex virus type 1

Scientific Title:Acronym

Intratumoral injection of naturally occurring mutant of HSV-1

Region

Japan


Condition

Condition

Non-CNS malignant solid tumor

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety, tolerability, anti-tumor activity, immune response and viral kinetics in patients with refractory solid tumor with an easily accessible and adequate for intratumoral injection lesion.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

MTD, DLT and adverse effects.

Key secondary outcomes

Anti-tumor activity


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

HF10

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Cytologically and/or histologically confirmed Non-CNS malignant solid tumor.
2) Refractory to standard therapies.
3) Life expectancy: >= 3 months from the date of consent.
4) Lesion to be treated: Measurable, easily accessible, and adequate for intratumoral injection.
5) Sero-positive to HSV-1.
6) Age: >= 20 years old.
7) Performance status (PS, ECOG scale): 0-2.
8) Adequate organ functions, measured as follows:
White blood cells: >= 2,000/mm3
Lymphocyte cell: >= 800/mm3
Hemoglobin: >= 8.0g/dl
Platelet: >= 50,000/mm3
Total birilbin: <= 1.5xULN
AST (GOT): <= 3.0xULN
ALT (GPT): <= 3.0xULN
Serum creatinine: <= 1.5xULN
PT INR: <= 1.5xULN
9) >= 4 weeks from prior therapy at start of HF10 injection.
10) Written informed consent.

Key exclusion criteria

1) Past history of severe hypersensitivity.
2) Positive for HBs antigen, HCV antibody or HIV antibody.
3) Experience of autoimmune disease requiring treatment during 6 months prior to consent.
4) Active multiple primary malignancy.
5) With lesions, such as visceral metastases or bone metastases, which need emergent therapies.
6) Use of anti-HSV drugs.
7) Use of steroids or immune-suppressive drugs.
8) Patients with severe complications.
9) Presence of central nervous system metastasis.
10) Lesion to be treated: high risk of bleeding.
11) Lesion to be treated: high risk of penetration or perforation.
12) Use of anti-platelet drugs or difficult to cessation of them.
13) Use of anticoagulant which is unsafe for intratumoral injection.
14) Pregnant or breastfeeding.
15) Patients who deny contraception during this study.
16) Any other cases that the attending doctor judges not appropriate to enroll to this study.

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Shiku

Organization

Mie University Graduate School of Medicine

Division name

Dep. of Cancer Vaccine / Immuno-Gene Therapy

Zip code


Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

+81-59-231-5187

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Mie University Graduate School of Medicine

Division name

Dep. of Cancer Vaccine / Immuno-Gene Therapy Study Secretariat

Zip code


Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

+81-59-231-5684

Homepage URL

http://www.shikuken.jp/

Email

cv-adm@doc.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Mie University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

TAKARA BIO INC

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



Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 10 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

Terminated

Date of protocol fixation

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 02 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

2012 Year 02 Month 10 Day

Last modified on

2015 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008523


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name