UMIN-CTR Clinical Trial

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

Condition
Condition	MAGE-A4-expressing therapy-resistant cancer (non origin-limited)
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic 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-tolerable dose and give biological recommended dose by evaluating safety profiles and immune responses with repeated doses of CHP-MAGE-A4 vaccine in a dose-escalating study of 100 or 300 microgram.
Basic objectives2	Others
Basic objectives -Others	To evaulate tumor response, progression-free time, 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-tolerable dose, dose-limting toxicity, profiles of adverse events. Efficacy: MAGE-A4-specific immune responses
Key secondary outcomes	Efficacy:tumor responses, progression-free time, overall survival, response-duration time and time-to-progression

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	Medicine Vaccine
Interventions/Control_1	Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 100 microgram or 300 microgram,every two weeks, repeated at least six cycles
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.MAGE-A4-expressing therapy-resistant cancer, with clinical stage III or IV, recurrent, metastatic disease, or at high-risk if reccurrence. 2.histoligically confirmed 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 2,000/uL or more. Hemoglobin 8.0 g/dl or more. Platelets 75,000/uL or more. Serum bilirubin: within 1.5 times of normal upper level(within 3 times in case of liver damage). AST(GOT)/ALT(GPT): within 2.5 times of normal upper level(within 5 times in case of liver damage). 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 corticostoroid, immuno-suppressive or -stimulating agents, radiotherapy, or surgery to 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 Hiroshi Shiku
Organization	Mie University Graduate School of Medicine
Division name	Immuno-Gene Therapy
Zip code
Address	2-174, Edobashi, Tsu, Mie, 514-8507 Japan
TEL	059-231-5187
Email	kageyama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinichi Kageyama
Organization	CHP-MAGE-A4 clinical trial registry
Division name	Cancer vaccine, Mie Universituy
Zip code
Address	2-174, Edobashi, Tsu, Mie, 514-8507 Japan
TEL	059-231-5280
Homepage URL
Email	kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute	CHP-MAGE-A4 cancer vaccine study at Mie University
Institute
Department

Funding Source
Organization	Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
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Address
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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	2008 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.oncotarget.com/index.php?journal=oncotarget&page=article&op=view&path%5B%5D=26323&path%5B
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 10 Month 30 Day
Date of IRB
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date	2012 Year 03 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	2008 Year 12 Month 25 Day
Last modified on	2018 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001877

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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