UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002392 |
|---|---|
| Receipt number | R000002892 |
| Scientific Title | Phase 1/2 study of Multiple-Vaccine with CpG-ODN Therapy in Patient with Refractory Colon Cancer to Chemotherapy. |
| Date of disclosure of the study information | 2009/08/28 |
| Last modified on | 2015/08/21 11:04:36 |
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Basic information
Public title
Phase 1/2 study of Multiple-Vaccine with CpG-ODN Therapy in Patient with Refractory Colon Cancer to Chemotherapy.
Acronym
Phase 1/2 study of Multiple-Vaccine with CpG-ODN Therapy in Patient with Refractory Colon Cancer to Chemotherapy.
Scientific Title
Phase 1/2 study of Multiple-Vaccine with CpG-ODN Therapy in Patient with Refractory Colon Cancer to Chemotherapy.
Scientific Title:Acronym
Phase 1/2 study of Multiple-Vaccine with CpG-ODN Therapy in Patient with Refractory Colon Cancer to Chemotherapy.
Region
| Japan |
Condition
Condition
Colon Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate safety and specific immuine responses on cancer vaccination therapy using multi peptides with CpG-ODN in patient with refractory Colon cancer to chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of safety and specific immune response
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
RNF43,TOMM34,VEGFR1,VEGFR2 peptides restricted to HLA-A*2402 (3.0mg for each) are administered four times once a week.
Interventions/Control_2
RNF43,TOMM34,VEGFR1,VEGFR2 peptides restricted to HLA-A*2402 (3.0mg for each) with CpG 7909 (0.02mg/kg) are administered four times once a week.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically and/or cytologically proven Colon Cancer, which is refractory to standard chemotherapy.
2.ECOG performance status 0-1
3.No severe postoperative complications
4.Age between 20 to 85
5.normal funcitons in vital organs
6.Life expectancy > 3 months
7.HLA-A*2402
8.Able and willing to give valid written informed consent
Key exclusion criteria
1.Pregnancy
2.Breastfeeding
3.Concurrent treatment with steroids or immunosuppressing agent
4.No other malignancy requiring treatment
5.No severe cardio-vascular disease
6.Decision of unsuitableness by principal investigator or physician-in-charge
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Aruga |
Organization
Tokyo Women's Medical University
Division name
Surgery
Zip code
Address
8-1, Kawada-chou, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Medical Science, The university of Tokyo
Division name
Human genome center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Institute of Medical Science, The university of Tokyo.
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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 | 08 | Month | 28 | 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
| 2009 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | 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 | 08 | Month | 27 | Day |
Last modified on
| 2015 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002892
