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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004945
Receipt No. 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

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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
Institute Tokai University School of Medicine
Institute
Department

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
URL(English) https://upload.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


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