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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003188
Receipt No. R000003864
Scientific Title A phase I study of cancer vaccine with CHP-MAGE-A4 in patients with advanced cancers expressing MAGE-A4 antigen
Date of disclosure of the study information 2010/02/15
Last modified on 2015/02/15

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Basic information
Public title A phase I study of cancer vaccine with CHP-MAGE-A4 in patients with advanced cancers expressing MAGE-A4 antigen
Acronym CHP-MAGE-A4 cancer vaccine
Scientific Title A phase I study of cancer vaccine with CHP-MAGE-A4 in patients with advanced cancers expressing MAGE-A4 antigen
Scientific Title:Acronym CHP-MAGE-A4 cancer vaccine
Region
Japan

Condition
Condition Advanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), colon cancer.
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Surgery in general Gastrointestinal surgery
Chest surgery
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 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale. NY-ESO-1 specific immunity.
Key secondary outcomes Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).

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 CHP-MAGE-A4 300microgram
Every 2 weeks x 6 times
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.Histological diagnosis of any type of cancers expressing MAGE-A4 antigen.
2.Advanced cancer patient.
3.Performance status of 0-2.
4.Age over 20 years.
5.At least 4 weeks since radiotherapy, biological therapy, chemotherapy or surgery prior to first dosing of study agent.
6.Life expectancy > 4 months.
7.Laboratory values within the following limits:
WBC > 2000/mm3
Hemoglobin> 8.0 g/dL
Platelet count > 75,000/mm3
Serum bilirubin < 2.0 mg/dl
AST,ALT < 150 IU/l
Serum creatmine < 2.5 mg/dL
9.Able and willing to give witnessed, written informed consent for participation in the trial
Key exclusion criteria 1.Other serious illnesses.
2.History of immunodeficiency disease or autoimmune disease.
3.Metastatic disease to the central nervous system, unless treated and stable.
4.Other malignancy
5.Known HIV, positivity.
6.Concomitant treatment with steroids.
7.Pregnancy or lactation.
8.Lack of availability of the patient for immunological and clinical follow-up assessment.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki
Organization Osaka University Graduate School of Medicine
Division name Department of Surgery
Zip code
Address 2-2 Ymada-oka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3251
Email hwada@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Wada
Organization Osaka University Graduate School of Medicine
Division name Department of Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3251
Homepage URL http://www.med.osaka-u.ac.jp/pub/gesurg/consultation/jyobu_shouka/vaccine/index.html
Email hwada@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Surgery
Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) The Ministry of Education, Culture, Sports, Science and Technology of Japan.

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 大阪大学医学部付属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25218300
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 02 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 15 Day
Last modified on
2015 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003864

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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