UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002907 |
|---|---|
| Receipt number | R000003471 |
| Scientific Title | Phase II clinical trial of personalized peptide vaccination for Biliary cancer (Cholangiocell carcinoma,Gallbladder cancer and Biliary tract cancer) patients |
| Date of disclosure of the study information | 2009/12/16 |
| Last modified on | 2019/12/06 13:27:32 |
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Basic information
Public title
Phase II clinical trial of personalized peptide vaccination for 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 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
YES
Objectives
Narrative objectives1
Up to 4 from the 31 candidate peptides, to which peptide specific IgG are detected before vaccination,are administered to malignant Biliary cancer patients. The aim of the study is to investigate immune response and also analyze a relationship between the immune response and overall survival.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluation of immune responses (anti-peptide IgG) before and after personalized peptide vaccination.
Key secondary outcomes
1. Evaluation of long-term prognosis (progression free survival and overall survival).
2. Adverse events of peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.
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 | Vaccine |
Interventions/Control_1
<1st treatment: total 8 times, which include weekly injection for 4 times followed by bi-weekly injection for 4 times>
Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).
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 be satisfactory the following conditions.
1) patients must be diagnosed as grade III or IV Biliary cancer. Presence of target legion, former treatment, and disease stage are 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 900 per mm3
Hb is more than 8.0 g per dL
Platelet is more than 50000 per mm3
Serum creatinine is less than 2.0 mg per dL
Total bilirubin is less than 2.5 mg per dL
6) patients must be more than 18 year old.
7) written informed consent must be obtained from patients.
8) patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.
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) (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.
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, Fukuoka 830-0011
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 | 12 | Month | 16 | 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 | 11 | Month | 19 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | 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 | 12 | Month | 16 | Day |
Last modified on
| 2019 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003471
