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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002392
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Institute of Medical Science, The university of Tokyo.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002892

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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