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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008820
Receipt No. R000010357
Scientific Title Phase I study of peptide vaccination in patients with refractory gastrointestinal cancer
Date of disclosure of the study information 2012/09/03
Last modified on 2014/08/31

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Basic information
Public title Phase I study of peptide vaccination in patients with refractory gastrointestinal cancer
Acronym GI Peptide Vaccination
Scientific Title Phase I study of peptide vaccination in patients with refractory gastrointestinal cancer
Scientific Title:Acronym GI Peptide Vaccination
Region
Japan

Condition
Condition Gastrointestinal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine recommended dose of peptide vaccination in patients with refractory gastrointestinal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes To evaluate dose-limiting toxicity and immune response
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Vaccination of 10 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) refractory gastrointestinal cancer
2) with or without measurable lesion
3) enable to ingestion
4) ECOG PS 0 or 1
5) age 20-80 years
6) preserved organ functions
7) written informed consent
8) more than 3 months of expected survival period
Key exclusion criteria 1) active double cancer
2) active infection
3) pregnancy, the desire to preserve fecundity, or lactating woman
4) mental disorder
5) steroid treatment
6) uncontrolled diabetes mellitus
7) unstable angina or myocardial infarction within 6 months
8) other severe complications
9) active bleeding
10) massive ascites
11) massive pleural effusion
12) HBs antigen-positive
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhide Yamada
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Iwasa
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address
TEL
Homepage URL
Email siwasa@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Cancer Research from the Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kurume University
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
2012 Year 09 Month 03 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
2012 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 09 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
2012 Year 08 Month 31 Day
Last modified on
2014 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010357

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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