UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003188 |
|---|---|
| Receipt number | 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 09:14:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hwada@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Surgery
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003864
