UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002022
Receipt number R000002468
Scientific Title Phase I / II clinical trial of peptide vaccination therapy for unresectable / recurrent pancreatic cancer to be refractory to chemotherapy by using new tumor antigen KIF20A and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization
Date of disclosure of the study information 2009/05/31
Last modified on 2015/06/01 14:09:03

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Basic information

Public title

Phase I / II clinical trial of peptide vaccination therapy for unresectable / recurrent pancreatic cancer to be refractory to chemotherapy by using new tumor antigen KIF20A and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization

Acronym

Phase I / II clinical trial of peptide vaccination therapy for pancreatic cancer

Scientific Title

Phase I / II clinical trial of peptide vaccination therapy for unresectable / recurrent pancreatic cancer to be refractory to chemotherapy by using new tumor antigen KIF20A and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization

Scientific Title:Acronym

Phase I / II clinical trial of peptide vaccination therapy for pancreatic cancer

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The aim of the study is to investigate safety and overall survival time about cancer vaccination therapy by using new tumor antigen KIF20A and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization against patients who have unresectable / recurrent pancreatic cancer to be refractory to chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

safety

Key secondary outcomes

immunologicaresponse and clinocal efficacy


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

Cancer vaccination therapy by using new tumor antigen KIF20A and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization against patients who have unresectable / recurrent pancreatic cancer to be refractory to chemotherapy.

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients who have unresectable / recurrent pancreatic cancer to be refractory to chemotherapy
2. Performance status (ECOG) of the patients are 0-2.
3. more than 20, less than 85 years of age.
4. The presence or absence of measurable or evaluable lesions by RECIST was not taken into account.
5. Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment.
6. Patients who can expect the survival of three months or more.
7. WBC count more than 3000/mm3, less than 15000/mm3. Plt count more than 75000/mm3. AST and ALT less than 150IU/L. T-Bil less than 3.0mg/dl. Creatinine less than 2.0mg/dl.
8. All patients gave written informed consent.

Key exclusion criteria

1. Patients have uncontrollable associated cancer.
2. Patients have uncontrollable severe infectional diseases.
3. Patients have severe trauma.
4. Patients who are treated with steroid or immunotherapy during clinical trial.
5. Pregnancy or lactation.
6. Patients who have non-recovered injury.
7. Patients judged inappropriated by doctors.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sumio Watanabe

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code


Address

2-1-1 Hongo Bunkyo-ku Tokyo

TEL

03-3813-3111

Email

sumio@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junko Kato

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code


Address

Department of Gastroenterology, Juntendo University School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tok

TEL

03-3813-3111

Homepage URL


Email

jun-kato@juntendo.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Juntendo University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

2009 Year 05 Month 31 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2009 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 05 Month 01 Day

Last follow-up date

2013 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 05 Month 31 Day

Last modified on

2015 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002468


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name