UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002153 |
|---|---|
| Receipt number | 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 16:07:12 |
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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 | Obstetrics 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
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
shu-ueda@kitano-hp.or.jp
Sponsor or person
Institute
The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002610
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