UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001884 |
|---|---|
| Receipt number | R000002273 |
| Scientific Title | Phase II clinical trial of personalized peptide vaccination for standard therapy failed Biliary cancer(Cholangiocell carcinoma,Gallbladder cancer and Biliary tract cancer) patients |
| Date of disclosure of the study information | 2009/04/14 |
| Last modified on | 2019/10/30 13:12:06 |
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Basic information
Public title
Phase II clinical trial of personalized peptide vaccination for standard therapy failed Biliary cancer(Cholangiocell carcinoma,Gallbladder cancer and Biliary tract cancer) patients
Acronym
Peptide vaccination for Biliary cancer patients
Scientific Title
Phase II clinical trial of personalized peptide vaccination for standard therapy failed Biliary cancer(Cholangiocell carcinoma,Gallbladder cancer and Biliary tract cancer) patients
Scientific Title:Acronym
Peptide vaccination for Biliary cancer patients
Region
| Japan |
Condition
Condition
Biliary cancer (Cholangiocell carcinoma,Gallbladder cancer and Biliary tract cancer)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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 immunological responses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
Key secondary outcomes
1.Evaluation of long-term prognosis (progression free survival and total survival).
2.Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(1st treatment: total 6 times, every weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).
Day 8, 15, 22, 29, 36: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 45: Final evaluation.
The 1st treatment (total 6 times, every weeks) is finished
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1) Patients must be diagnosed as standard therapy failed Biliary cancer.(Cholangiocell carcinoma,Gallbladder cancer and Biliary tract cancer)
The patients must be suffering from standerd therapy as Oreration and Chemotherapy
2) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type.
3) Patients must have IgG reactive to at least two of candidate peptides.
4) Patients must be at a score level
0~1 of performance status (PS) (ECOG).
5) Patients must be expected to survive more than 3 months.
6) Patients must satisfy the followings:
WBC >= 2,500/mm3
Lymphocyte >= 900/mm3
Hb >= 8.0g/dl
Platelet >= 50,000/mm3
Serum Creatinine <= 2.0mg/dl
Total Bilirubin <= 2.5mg/dl
7) Patients must be more 18 year-old.
8) Written informed consent must be obtained from patients.
Key exclusion criteria
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) 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL
0942-27-5210
yutani@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University
Division name
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Zip code
Address
Asahi-machi 67, Kurume,
TEL
0942-31-7744
Homepage URL
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Cancer Vaccine Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 14 | 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 | 03 | Month | 30 | Day |
Date of IRB
| 2009 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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 | 04 | Month | 14 | Day |
Last modified on
| 2019 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002273
