UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001999 |
|---|---|
| Receipt number | R000002369 |
| Scientific Title | The phase I,II clinical study of cancer vaccine for intractable malignant tumor expressing MAGE-A4-antigen |
| Date of disclosure of the study information | 2009/05/22 |
| Last modified on | 2015/11/30 15:40:51 |
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Basic information
Public title
The phase I,II clinical study of cancer vaccine for intractable malignant tumor expressing MAGE-A4-antigen
Acronym
The clinical study of cancer vaccine for intractable malignant tumor
Scientific Title
The phase I,II clinical study of cancer vaccine for intractable malignant tumor expressing MAGE-A4-antigen
Scientific Title:Acronym
The clinical study of cancer vaccine for intractable malignant tumor
Region
| Japan |
Condition
Condition
Intractable malignant tumors expressing MAGE-A4 antigen
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of CHP-MAGE-A4 cancer vaccine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
the adverse events and the ability to induce antigen specific immune responses
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
CHP-MAGE-A4 injection of 100 µg
Interventions/Control_2
CHP-MAGE-A4 injection of 300 µg
Interventions/Control_3
CHP-MAGE-A4 injection of 300 µg and concomittant injection of OK-432 as an adjuvant
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
Cancer patients expressing MAGE-A4 antigen
Key exclusion criteria
HIV positive, autoimmune diseases,pregnancy,breast feeding
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kondo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
Kita-15,Nishi-7,kita-ku,Sapporo,Hokkaido,Japan
TEL
011-706-7714
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tsuchikawa |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 22 | 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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 22 | Day |
Last modified on
| 2015 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002369
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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