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
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/
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
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
