UMIN-CTR Clinical Trial

Basic information
Public title	Cancer specific vaccine therapy using HLA-A24 restricted epitope-peptide for patients with advanced metastatic colorectal cancer.PhaseI/II clinical trial.
Acronym	Cancer peptide vaccine for advanced metastatic cancer.
Scientific Title	Cancer specific vaccine therapy using HLA-A24 restricted epitope-peptide for patients with advanced metastatic colorectal cancer.PhaseI/II clinical trial.
Scientific Title:Acronym	Cancer peptide vaccine for advanced metastatic cancer.
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To detemine the safety and responsiveness of peptide vaccines cocktail(FOXM1,MELK,HJURP) for HLA-A24 positive patients with advanced colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety Overall survival
Key secondary outcomes	Immunological responce(in vitro CTL induction) Responsiveness(tumor size)

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	Subctaneus injection of cancer peptide vaccine(three 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Standard therapies failured 2 Performance status 0-1 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 =>50000, GOT, GPT =<150, Cr =< 3.0 TB =< 3.0 7 HLA-A24 positive 8 Written informed consent
Key exclusion criteria	1 Expectant 2 During lactation 3 possible expectant women 4 Active infectious diseases 5 Systemic use of steroid hormones or immunosuppressive drugs 6 Others (Doctors judges)
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Takahashi
Organization	Hokkaido Cancer Center
Division name	Gatroenterology
Zip code
Address	Sapporo City, Hokkaido
TEL	011-811-9111
Email

Public contact
Name of contact person	1st name Middle name Last name Yasuo Takahashi
Organization	Hokkaido Cancer Center
Division name	Gastroenterology
Zip code
Address	Sapporo City, Hokkaido
TEL	011-811-9111
Homepage URL
Email	takahasi@sap-cc.go.jp

Sponsor
Institute	Hokkaido Cancer Center
Institute
Department

Funding Source
Organization	Hokkaido Cancer Center
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	北海道がんセンター（北海道）

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 10 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	2010 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date	2011 Year 02 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 01 Day
Last modified on	2012 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005938

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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