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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002153
Receipt No. R000002610
Scientific Title CHP-MAGE-A4 cancer vaccine study for refractory MAGE-A4-expressing cancer
Date of disclosure of the study information 2009/07/02
Last modified on 2014/07/31

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Basic information
Public title CHP-MAGE-A4 cancer vaccine study for refractory MAGE-A4-expressing cancer
Acronym CHP-MAGE-A4 cancer vaccine study
Scientific Title CHP-MAGE-A4 cancer vaccine study for refractory MAGE-A4-expressing cancer
Scientific Title:Acronym CHP-MAGE-A4 cancer vaccine study
Region
Japan

Condition
Condition MAGE-A4-expressing refractory cancer patients (non origin-limited)
or patients who refuse standard therapy
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Breast surgery Obsterics and gynecology
Oto-rhino-laryngology Urology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To see maximum tolerated dose and give biological recommended dose by evaluating safety profiles and immune responses with repeated doses of CHP-MAGE-A4 vaccine in a dose-escalation study of 100 or 300 microgram
Basic objectives2 Others
Basic objectives -Others To evaluate tumor responses, progression-free survival, overall survival, response duration time, and time to progression
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Safety: maximum tolerated dose, dose-limiting toxicity, profiles of adverse events
Efficacy: MAGE-A4-specific immune responses
Key secondary outcomes Efficacy: tumor responses, progression-free survival, overall survival, response duration time, and time to progression

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 2
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Subcutaneous injection of 100 microgram CHP-MAGE-A4 protein complex vaccine, every two weeks, repeated at least six cycles
Interventions/Control_2 Subcutaneous injection of 300 microgram CHP-MAGE-A4 protein complex vaccine, every two weeks, repeated at least six cycles
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. Refractory MAGE-A4-expressing cancer, with clinical stage III or IV, recurrent, metastatic disease, or at high-risk of recurrence
2.Histologically comfirmed malignant tumor
3.MAGE-A4 antigen expressing
4.Performance status (ECOG) 0 to 2
5.Aged twenty or more, male or female
6.At least four-month life expectancy
7.Normal major organ function and meeting the criteria below
White cell counts: 2000/uL or more
Hemoglobin: 8.0 g/dL or more
Platelets: 75000/uL or more
Serum bilirubin: within 1.5 times of normal upper level (within 3 times in case of liver metastasis)
AST/ALT: within 2.5 times of normal upper level (within 3 times in case of liver metastasis)
Serum creatinine: within 1.5 times of normal upper level
8.Not willing to be pregnant (both sexes)
9. Having written informed consent
Key exclusion criteria 1.HIV-positives
2.Double cancers
3.Autoimmune disease
4.History of serious hypersensitivity
5.Active CNS metastasis
6.Lasting less than four weeks from the previous chemotherapy, systemic corticosteroid, immuno-suppresive or stimulating agents, radiotherapy, or operation for primary tumors
7.Pregnant or lactating
8.Inappropriate for study entry judged by an attending physician
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shugo Ueda
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name Department of Gastroenterological Surgery and Oncology
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
TEL 06-6312-8831
Email shu-ueda@kitano-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shugo Ueda
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name Department of Gastroenterological Surgery and Oncology
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
TEL 06-6312-8831
Homepage URL
Email shu-ueda@kitano-hp.or.jp

Sponsor
Institute The Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research by The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Cancer Vaccine
Mie University Graduate School of Medicine
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 07 Month 02 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
2008 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 01 Day
Last modified on
2014 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002610

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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