UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005634
Receipt number R000006657
Scientific Title Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.
Date of disclosure of the study information 2011/05/24
Last modified on 2014/06/24 14:24:49

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to standard therapy failed liver cancer patients (except HCV positive patients in stage IV). 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.


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

personalized peptide vaccine plus best supportive care (BSC)
( 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: Final evaluation.
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, corticosteroids, and transfusion) during the vaccination.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects must satisfy 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 performance status (PS) (ECOG).
3) Patients must have IgG reactive to at least two of candidate peptides.
4)Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33).
6) Patients must satisfy the followings:
WBC is more than 2,000/mm3
Lymphocyte is more than 900/mm3
Hb is more than 8.0g/dl
Platelet is more than 40,000/mm3
Serum Creatinine is less than 2.0mg/dl
Total Bilirubin is less than 2.5mg/dl
6) Patients must be more 20 year-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)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.
3) Patient who has doubt of immune deficiency disease or opportunistic infection.
4) Patients with the past history of severe allergic reactions.
2) Women during pregnancy or breast-feeding.
6) Patient of hepatic encephalopathy two degrees or more
7) Patients with brain metastasis.
8) Patients who are judged inappropriate for the clinical trial by doctors.

Target sample size

41


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

0942-31-7551

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

TEL

0942-31-7572

Homepage URL


Email

akiymd@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division

Institute

Department

Personal name



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

2011 Year 05 Month 24 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 02 Month 22 Day

Date of IRB


Anticipated trial start date

2011 Year 05 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 05 Month 24 Day

Last modified on

2014 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name