Unique ID issued by UMIN | UMIN000005127 |
---|---|
Receipt number | R000006096 |
Scientific Title | Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer |
Date of disclosure of the study information | 2011/02/23 |
Last modified on | 2015/06/25 12:52:40 |
Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer
Peptide vaccination with CpG for unresectable biliary tract cancer
Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer
Peptide vaccination with CpG for unresectable biliary tract cancer
Japan |
biliary tract cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
The aim of this study is to assess the safety and specific immune responses on peptide vaccination with CpG in patients with unresectable biliary tract cancer.
Safety
Phase I
Assessment of safety
Assessment of specific immune response
Interventional
Parallel
Non-randomized
Open -no one is blinded
Dose comparison
2
Treatment
Vaccine |
Patients will be vaccinated once a week for eight weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted FOXM1 peptide(2mg), MELK peptide(2mg), HJURP peptide(2mg), VEGFR1 peptide(2mg), VEGFR2 peptide(2mg) mixed with Montanide ISA-51 will be administered by subcutaneous injection.
Patients will be vaccinated once a week for eight weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted FOXM1 peptide(2mg), MELK peptide(2mg), HJURP peptide(2mg), VEGFR1 peptide(2mg), VEGFR2 peptide(2mg) mixed with CpG (1mg) plus Montanide ISA-51 will be administered by subcutaneous injection.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1.Clinically or pathologically diagnosed biliary tract cancer
2.Age between 20 to 80
3.Life expectancy > 3 months
4.No severe organ function impairment
5.Patients who have unresectable tumors to be refractory to chemotherapy
6.Written informed consent of the patient
7.Performance Status 0-2
1.Pregnancy or lactation
2.Decision of unsuitableness by principal investigator
3.Patient with severe underlying disease
4.Patient with severe allergy disease
10
1st name | |
Middle name | |
Last name | Masakazu Yamamoto |
Tokyo Women's Medical University
Department of Gastroenterological Surgery
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
yamamoto@ige.twmu.ac.jp
1st name | |
Middle name | |
Last name | Atsushi Aruga |
Tokyo Women's Medical University
Institute of Advanced Biomedial Engineering and Science
8-1 Kawada-cho, Shinjuku-ku. Tokyo
03-3353-8111
aruga.atsushi@twmu.ac.jp
Tokyo Women's Medical University
Department of Gastroenterological Surgery, Tokyo Women's Medical University
Self funding
Human Genome Center, Institute of Medical Science, The University of Tokyo
NO
東京女子医科大学病院(東京都)
2011 | Year | 02 | Month | 23 | Day |
Unpublished
Completed
2011 | Year | 01 | Month | 11 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 02 | Month | 23 | Day |
2015 | Year | 06 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006096
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |