Unique ID issued by UMIN | UMIN000006249 |
---|---|
Receipt number | R000007367 |
Scientific Title | Randomized Phase II clinical trial of personalized peptide vaccination with low dose of cyclophosphamide for standard therapy failer Biliary cancer patients. |
Date of disclosure of the study information | 2011/08/30 |
Last modified on | 2018/04/11 16:59:53 |
Randomized Phase II clinical trial of
personalized peptide vaccination with low dose of cyclophosphamide for standard therapy failer Biliary cancer patients.
Randomized Phase II clinical of personalized peptide vaccination for standard therapy failed Biliary cancer.
Randomized Phase II clinical trial of
personalized peptide vaccination with low dose of cyclophosphamide for standard therapy failer Biliary cancer patients.
Randomized Phase II clinical of personalized peptide vaccination for standard therapy failed Biliary cancer.
Japan |
Biliary cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
Up to 4 from the 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to standard therapy failed Biliary cancer patients. The aim of the study is to investigate effects of low-dose cyclophosphamide on vaccine-induced, correlativity of overall survival and immuno responses.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Number of immuno-regulatory cells.
1. overall survival
2.Evaluation of immune responses (anti-peptide IgG,CTL).
3.Adverse effects of peptide vaccination safety of the protocol is evaluated based on the NCI-CTCAE.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is not considered as adjustment factor.
2
Treatment
Medicine | Vaccine |
A:Personalized peptide vaccination with low dose of cyclophosphamide treatment.
The cyclophosphamide of the low dosage (100mg / day) is administered for seven days before the day of tha peptide vaccine beginning.
Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination.
1st treatment:total 6 times,every 1 weeks
2nd treatment:total 6 times,eveyr 2 weeks
and if the patient hopes, the treatment can be continued (at 2-6 week intervals ).
B:Personalized peptide vaccine alone
Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination.
1st treatment:total 6 times,every 1 weeks
2nd treatment:total 6 times,eveyr 2 weeks
and if the patient hopes, the treatment can be continued (at 2-6 week intervals ).
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must satisfy the following conditions.
1) Patients with standard therapy failed Biliary cancer.
Presence of target legion is not considered.
2) Patients must be at a score level 0-1 of ECOG performance status.
3) Patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types.
4) Patients must be expected to survive more than 3 months.
5) Patients must satisfy the followings.
WBC is more than 2500 per mm3
Lymphocyte is more than 1000 per mm3
Hb is more than 8.0 g per dL
Platelet is more than 50000 per mm3
Serum creatinine is less than 2.0mg per dL
Total bilirubin is less than 2.5mg per dL
6) Patients must be more than 20 years old.
7) Written informed consent must be obtained from patients.
8) PatientsPatients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.
The following patients must be excluded.
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2) Patients with the past history of severe allergic reactions.
3) (Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility.
(Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination."
4) Patients who are judged inappropriate for the clinical trial by doctors.
5)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
44
1st name | |
Middle name | |
Last name | Shigeru Yutani |
Kurume University
Cancer Vaccine Center
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
0942-27-5210
yutani@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Akira Yamada |
Kurume University
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
0942-31-7572
akiymd@med.kurume-u.ac.jp
Kurume University Cancer Vaccine Center
None
Other
NO
2011 | Year | 08 | Month | 30 | Day |
Unpublished
Completed
2011 | Year | 07 | Month | 15 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 08 | Month | 30 | Day |
2018 | Year | 04 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007367
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |