UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005127
Receipt number R000006096
Scientific Title Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer
Date of disclosure of the study information 2011/02/23
Last modified on 2015/06/25 12:52:40

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Basic information

Public title

Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer

Acronym

Peptide vaccination with CpG for unresectable biliary tract cancer

Scientific Title

Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer

Scientific Title:Acronym

Peptide vaccination with CpG for unresectable biliary tract cancer

Region

Japan


Condition

Condition

biliary tract cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to assess the safety and specific immune responses on peptide vaccination with CpG in patients with unresectable biliary tract cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Assessment of safety

Key secondary outcomes

Assessment of specific immune response


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

Patients will be vaccinated once a week for eight weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted FOXM1 peptide(2mg), MELK peptide(2mg), HJURP peptide(2mg), VEGFR1 peptide(2mg), VEGFR2 peptide(2mg) mixed with Montanide ISA-51 will be administered by subcutaneous injection.

Interventions/Control_2

Patients will be vaccinated once a week for eight weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted FOXM1 peptide(2mg), MELK peptide(2mg), HJURP peptide(2mg), VEGFR1 peptide(2mg), VEGFR2 peptide(2mg) mixed with CpG (1mg) plus Montanide ISA-51 will be administered by subcutaneous injection.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1.Clinically or pathologically diagnosed biliary tract cancer
2.Age between 20 to 80
3.Life expectancy > 3 months
4.No severe organ function impairment
5.Patients who have unresectable tumors to be refractory to chemotherapy
6.Written informed consent of the patient
7.Performance Status 0-2

Key exclusion criteria

1.Pregnancy or lactation
2.Decision of unsuitableness by principal investigator
3.Patient with severe underlying disease
4.Patient with severe allergy disease

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakazu Yamamoto

Organization

Tokyo Women's Medical University

Division name

Department of Gastroenterological Surgery

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email

yamamoto@ige.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Aruga

Organization

Tokyo Women's Medical University

Division name

Institute of Advanced Biomedial Engineering and Science

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku. Tokyo

TEL

03-3353-8111

Homepage URL


Email

aruga.atsushi@twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterological Surgery, Tokyo Women's Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Human Genome Center, Institute of Medical Science, The University of Tokyo

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

東京女子医科大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 23 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 01 Month 11 Day

Date of IRB


Anticipated trial start date

2011 Year 03 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 02 Month 23 Day

Last modified on

2015 Year 06 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name