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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006249
Receipt No. 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

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Basic information
Public title Randomized Phase II clinical trial of
personalized peptide vaccination with low dose of cyclophosphamide for standard therapy failer Biliary cancer patients.
Acronym Randomized Phase II clinical of personalized peptide vaccination for standard therapy failed Biliary cancer.
Scientific Title Randomized Phase II clinical trial of
personalized peptide vaccination with low dose of cyclophosphamide for standard therapy failer Biliary cancer patients.
Scientific Title:Acronym Randomized Phase II clinical of personalized peptide vaccination for standard therapy failed Biliary cancer.
Region
Japan

Condition
Condition Biliary 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 effects of low-dose cyclophosphamide on vaccine-induced, correlativity of overall survival and immuno responses.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Number of immuno-regulatory cells.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 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 ).
Interventions/Control_2 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 ).
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
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.
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.
Target sample size 44

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
Email 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, Japan
TEL 0942-31-7572
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
Institute
Department

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
Email

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
2011 Year 08 Month 30 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
2011 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 08 Month 30 Day
Last modified on
2018 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.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


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