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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001999
Receipt No. 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

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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
Obsterics 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
Email

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
Email

Sponsor
Institute Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002369

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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