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
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
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
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
