UMIN ID: UMIN000002392
Registered date:28/08/2009
Phase 1/2 study of Multiple-Vaccine with CpG-ODN Therapy in Patient with Refractory Colon Cancer to Chemotherapy.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Colon Cancer |
Date of first enrollment | 2009/08/01 |
Target sample size | 25 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | RNF43,TOMM34,VEGFR1,VEGFR2 peptides restricted to HLA-A*2402 (3.0mg for each) are administered four times once a week. 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. |
Outcome(s)
Primary Outcome | Evaluation of safety and specific immune response |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 85years-old |
Gender | Male and Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Institute of Medical Science, The university of Tokyo. |
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Secondary Sponsor | |
Source(s) of Monetary Support | New Energy and Industrial Technology Development Organization |
Secondary ID(s) |
Contact
public contact | |
Name | |
Address | Japan |
Telephone | |
Affiliation | Institute of Medical Science, The university of Tokyo Human genome center |
scientific contact | |
Name | Atsushi Aruga |
Address | 8-1, Kawada-chou, Shinjuku-ku, Tokyo Japan |
Telephone | |
Affiliation | Tokyo Women's Medical University Surgery |