UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008007
Receipt number R000009417
Scientific Title Phase I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.
Date of disclosure of the study information 2012/05/21
Last modified on 2017/09/27 09:10:29

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Basic information

Public title

Phase I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.

Acronym

Phase I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.

Scientific Title

Phase I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.

Scientific Title:Acronym

Phase I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.

Region

Japan


Condition

Condition

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, and immune response in patients with NY-ESO-1-expressing malignant solid tumor treated with the IMF-001 and the immunological adjuvant MIS416.

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

Immune response


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

Vaccine

Interventions/Control_1

IMF-001, MIS416

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) Pathologically confirmed malignant solid tumor.
2) Refractory to standard therapies.
3) NY-ESO-1 expression in tumor confirmed by immunohistochemistry or RT-PCR.
4) Life expectancy: >= 3 months from the date of consent.
5) Age: >= 20 years old.
6) Performance status (PS, ECOG scale): 0-2.
7) Adequate organ functions, measured as follows:
White blood cells: >= 2,000/mm3
Hemoglobin: >= 8.0g/dl
Platelet: >= 75,000/mm3
Total birilbin: <= 1.5 x ULN
AST (GOT): <= 3.0 x ULN
ALT (GPT): <= 3.0 x ULN
Serum creatinine: <= 1.5 x ULN
8) >= 4 weeks from prior therapy at start of this treatment.
9) 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) Patient with disease requiring emergent radiotherapy.
6) Use of steroids (PSL >= 20mg / day) or immune-suppressive drugs.
7) Patients with severe complications.
8) History of other NY-ESO-1 related immunotherapy.
9) Pregnant or breastfeeding.
10) Patients who deny contraception during this study.
11) Any other cases that the attending doctor judges not appropriate to enroll to this study.

Target sample size

12


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

059-231-5187

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

059-231-5684

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

Foundation

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



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

三重大学医学部附属病院(三重県)


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 21 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

2012 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 06 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 05 Month 21 Day

Last modified on

2017 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009417


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name