UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007801 |
|---|---|
| Receipt number | R000007478 |
| Scientific Title | Phase I/II clinical trial of HLA-A24 restricted epitope peptide cocktail therapy with UFT+LV for patients with advanced metastatic colorectal cancer. |
| Date of disclosure of the study information | 2012/04/20 |
| Last modified on | 2012/05/07 20:50:39 |
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Basic information
Public title
Phase I/II clinical trial of HLA-A24 restricted epitope peptide cocktail therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Acronym
Peptide vaccine therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Scientific Title
Phase I/II clinical trial of HLA-A24 restricted epitope peptide cocktail therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Scientific Title:Acronym
Peptide vaccine therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Region
| Japan |
Condition
Condition
Advanced metastatic colorectal cancers
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the safty and in vitro CTL induction of peptides cocktail (RNF43, TOMM34, FOXM1, MELK, HJURP, VEGFR1, VEGFR2) with UFT+LV 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
Safty
Immunological response
(in vitro CTL induction)
Key secondary outcomes
Progression free survival
Overall survival
Data related to tumor regression
Tumor marker (CEA) profile
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
Subcutaneous injection of cancer vaccine (seven peptides)
UFT+LV
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 metastatic
colorectal cancers.
2 Performance status 0 - 2
3 More than 4 weeks after previous
therapy.
4 WBC >= 2000, Platelet >= 50000,
GOT GPT <= 150, T.bil <= 3, Cr <= 3
5 HLA-A24 positive
6 Informed consent
Key exclusion criteria
Pregnant
Lactation
Prognosis >= 3 months
Active infectious disease
Systemic use of steroid hormones or
immunosuppressive drugs.
Others (Doctors judges)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyotaka Okuno |
Organization
Kinki University School of Medicine
Division name
Department of Surgery
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka 589- 8511, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiaki Sugiura |
Organization
Kinki University School of Medicine
Division name
Department of Surgery
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka 589- 8511, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kinki University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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 | 04 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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 | 04 | Month | 20 | Day |
Last modified on
| 2012 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007478
