UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006295
Receipt number R000007425
Scientific Title Phase II clinical trial of combination of personalized peptide vaccination and Juzen-taiho-to for Pancreatic cancer patients who failed standard therapy or unresectable.
Date of disclosure of the study information 2011/09/06
Last modified on 2016/12/26 17:36:48

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Basic information

Public title

Phase II clinical trial of combination of personalized peptide vaccination and Juzen-taiho-to for Pancreatic cancer patients who failed standard therapy or unresectable.

Acronym

Phase II study of peptide vaccination for Pancreatic cancer patients.

Scientific Title

Phase II clinical trial of combination of personalized peptide vaccination and Juzen-taiho-to for Pancreatic cancer patients who failed standard therapy or unresectable.

Scientific Title:Acronym

Phase II study of peptide vaccination for Pancreatic cancer patients.

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of study is to investigate safety , immunity-enhancing , clinical effect of combination of personalized peptide vaccination and Juzen-taiho-to for Pancreatic cancer patients who failed standard therapy or unresectable.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Comparison between two groups of immune-enhancing effects.

Key secondary outcomes

1. Comparison between two groups of long-term prognosis.
2. Comparison between two groups of adverse,safety of peptide vaccination


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


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Vaccine

Interventions/Control_1

arm1:
Start date to the sixth administration of the peptide vaccine, by mouth three times a day Juzentaihoto. The amount of oral once 5g.
Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with adjuvant and subcutaneously inject (3.0 mg/peptide)( total 6 times, every 1 weeks).

Interventions/Control_2

arm2:
Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with adjuvant and subcutaneously inject (3.0 mg/peptide)( total 6 times, every 1 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



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 must be diagnosed as Pancreatic cancer of the standard therapy failed or the unresectable.
Presence of target lesion 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 2,500/mm3
Lymphocyte is more than 1,000/mm3
Hb is more than 8.0g/dl
Platelet is more than 50,000/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) 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)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) Patients with the past history of severe allergic reactions.
4) (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.
5) Patients who are judged inappropriate for the clinical trial by doctors.

Target sample size

60


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

0942-31-7744

Homepage URL


Email

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


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 09 Month 06 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 22 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 09 Month 06 Day

Last modified on

2016 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007425


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name