UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004945
Receipt number R000005887
Scientific Title Cancer peptide vaccine therapy for patients with advanced metastatic colorectal cancer. Phase I/II clinical trial.
Date of disclosure of the study information 2011/01/25
Last modified on 2015/08/21 14:50:30

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Basic information

Public title

Cancer peptide vaccine therapy for patients with advanced metastatic colorectal cancer. Phase I/II clinical trial.

Acronym

Cancer peptide vaccine for advanced metastatic colorectal cancer.

Scientific Title

Cancer peptide vaccine therapy for patients with advanced metastatic colorectal cancer. Phase I/II clinical trial.

Scientific Title:Acronym

Cancer peptide vaccine for advanced metastatic colorectal cancer.

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the safety and responsiveness of peptide vaccines cocktail (RNF43, TOMM34, KOC1, VEGFR1, VEGFR2) for HLA-A24 positive patients with advanced metastatic colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Safety
Responsiveness (tumor size)

Key secondary outcomes

Immunological response
(in vitro CTL induction)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is 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

Subcutaneous injection of cancer peptide vaccines (five peptides)

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1 Standard therapies failured
2 Performance status 0-2
3 Lesions identifiable with images
4 More than 4 weeks after previous therapy
5 Prognosis no less than 3 months
6 WBC 2000 -15000, Platelet =>75000, GOT, GPT =< 3 times, Cr =< 2.0
7 HLA-A24 positive
8 Written informed consent

Key exclusion criteria

1 Cardiac diseases necessitating treatments
2 Myocardial infarction less than 6 months
3 Expectant or possible expectant women During lactation
4 Active infectious diseases
5 Systemic use of steroid hormones or immunosuppressive drugs
6 Allergy to peptides or IFA
7 Others (Doctors judges)

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyasu Makuuchi

Organization

Tokai University School of Medicine

Division name

Department of Surgery

Zip code


Address

Isehara City, Kanagawa

TEL

0463-93-1121

Email

yasuda@is.icc.u-tokai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiei Yasuda

Organization

Tokai University School of Medicine

Division name

Department of Surgery

Zip code


Address

Isehara City, Kanagawa

TEL

0463-93-1121

Homepage URL


Email

yasuda@is.icc.u-tokai.ac.jp


Sponsor or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

NEDO
(New Energy Development Organization)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

The 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

東海大学医学部付属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2011 Year 01 Month 25 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

2008 Year 09 Month 08 Day

Date of IRB


Anticipated trial start date

2008 Year 12 Month 01 Day

Last follow-up date

2015 Year 01 Month 30 Day

Date of closure to data entry

2015 Year 01 Month 30 Day

Date trial data considered complete

2015 Year 01 Month 30 Day

Date analysis concluded

2015 Year 01 Month 30 Day


Other

Other related information



Management information

Registered date

2011 Year 01 Month 25 Day

Last modified on

2015 Year 08 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005887


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name