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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003029
Receipt No. R000003673
Scientific Title Phase II clinical trial of personalized peptide vaccination for liver cancer patients
Date of disclosure of the study information 2010/01/13
Last modified on 2019/01/07

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Basic information
Public title Phase II clinical trial of personalized peptide vaccination for liver cancer patients

Acronym Peptide vaccination for liver cancer patients

Scientific Title Phase II clinical trial of personalized peptide vaccination for liver cancer patients

Scientific Title:Acronym Peptide vaccination for liver cancer patients

Region
Japan

Condition
Condition liver 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 liver 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 personalized 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 liver 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 years 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
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
TEL 0942-31-7744
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
2010 Year 01 Month 13 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 No longer recruiting
Date of protocol fixation
2009 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 01 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
2010 Year 01 Month 13 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003673

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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