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Recruitment status Completed
Unique ID issued by UMIN UMIN000003520
Receipt No. R000004272
Scientific Title Randomized Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.
Date of disclosure of the study information 2010/04/22
Last modified on 2014/06/24

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Basic information
Public title Randomized Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.

Acronym Randomized Phase II study of peptide vaccination in HCV positive patients with advanced liver cancer.

Scientific Title Randomized Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.

Scientific Title:Acronym Randomized Phase II study of peptide vaccination in HCV positive patients with advanced liver cancer.

Region
Japan

Condition
Condition liver cancer

Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Up to 4 from the 32 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to HCV positive patients with standard therapy failed stage VI liver cancer. The aim of the study is to investigate the safety, immunological responses and antitumor activity.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Evaluation of antitumor activity (overall survival) of peptide vaccination.

Key secondary outcomes 1.Evaluation of response rate and long-term prognosis (overall survival).
2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0).
3.Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Arm 1: personalized peptide vaccine plus best supportive care (BSC)
(1st treatment: total 8 times, every 1 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, 43, 50: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 50: First evaluation.
(2nd treatment: total 8 times, every 2 weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides.
Day 15, 29, 43, 57, 71, 85, 99 : Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 99: Second evaluation.
(3rd treatment: total times, every 2 weeks)
Day 15, 29, 43, 57, 71, 85, 99 : Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 99: Third evaluation.
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, corticosteroids, and transfusion) during the vaccination.
Interventions/Control_2 Arm 2: Best supportive care (BSC) BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, orticosteroids, and transfusion) for 40 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects must be satisfactory the following conditions.
1) HCV positive patients with standard therapy failed stage VI liver cancer.
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 in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33).
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 80000 per mm3
Serum creatinine is less than 2.0 mg/dl
Total bilirubin is less than 2.5 mg/dl
6) patients must be more than 20 years old.
7) Patients must be expected to survive more than 3 months.
8) Written informed consent must be obtained from patients.
9) Prior treatment are allowed and must complete before random assignment with full recovery of related toxicity.
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 who are during pregnancy, lactation expectant, and desiring future fertility.
4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 84

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Yutani
Organization Kurume University

Division name Department of Immunology and Immunotherapy
Zip code
Address Asahi-machi 67, Kurume, Fukuoka 830-0011
TEL
Email

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 Research Center for Innovative Cancer Therapy, Clinical Research Division




Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization The Ministry of Education, Culture, Sports, Science, and Technology, Japan

Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Hirosaki University , Fukusima prefectural medical University, Showa University, Kinki University

Name of secondary funder(s) Kurume University


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 久留米大学病院(福岡県)、弘前大学病院(青森県)、福島県立医科大学病院(福島県)、昭和大学病院(東京都)、近畿大学病院(大阪府)
Kurume University Hosipital, Hirosaki University Hospital, Fukusima prefectural medical University Hospital, Showa University Hospital, Kinki University Hosipital

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 22 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
2010 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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 04 Month 22 Day
Last modified on
2014 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004272


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