UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008820 |
|---|---|
| Receipt number | 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 10:14:22 |
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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
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
siwasa@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010357
