UMIN-CTR Clinical Trial

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

Non-CNS malignant solid tumor

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

MTD, DLT and adverse effects.

Key secondary outcomes

Anti-tumor activity

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

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

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

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

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

Institute

Mie University Graduate School of Medicine

Institute

Department

Personal name

Organization

Mie University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

TAKARA BIO INC

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

Date of disclosure of the study information

2012

Year

02

Month

10

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

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 related 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