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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008007
Receipt No. 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

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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
Institute Mie University Graduate School of Medicine
Institute
Department

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
URL(English) https://upload.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


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