UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026163 |
|---|---|
| Receipt number | R000030046 |
| Scientific Title | A phase I study of a 5-peptide vaccine with immune modulators for patients with refractory metastatic colorectal cancer |
| Date of disclosure of the study information | 2017/03/20 |
| Last modified on | 2017/08/18 09:18:08 |
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Basic information
Public title
A phase I study of a 5-peptide vaccine with immune modulators for patients with refractory metastatic colorectal cancer
Acronym
A 5-peptide vaccine with immune modulators for patients with metastatic colorectal cancer
Scientific Title
A phase I study of a 5-peptide vaccine with immune modulators for patients with refractory metastatic colorectal cancer
Scientific Title:Acronym
A 5-peptide vaccine with immune modulators for patients with metastatic colorectal cancer
Region
| Japan |
Condition
Condition
refractory metastatic colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the safety and immune responses of a 5-peptide vaccine and immune modulators in patients with refractory metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The safety of the immune modulators with/without 5-peptide cocktail vaccine
Key secondary outcomes
1) peptide-specific CTL responses and the relationship with clinical responses
2)Overall survival and preogression-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
1)Immune modulators, composed of cyclophosphamide, metformin, celecoxib and cimetidine are administered orally for 1 week
2)Induction phase: 5-peptide cocktail vaccine weekly in combination with immune modulators are administered for 8 weeks
3)Maintenance phase: 5-peptide cocktail vaccine biweekly in combination with immune modulators are administered for 8 weeks
4)Extension phase: maintenance therapy is allowed depending on patient condition
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)standard therapy-refractory metastatic colorectal cancer
2)HLA-A24 positive patient
3)life expectancy at least 3 months
4)older than 20 years of age
5)ECOG performance status, 0,1 or 2
6)having measurable metastatic lesion
7) WBC count more than 2,000 and % of lymphocyte more than 15%
8)adequate bone marrow, liver and renal function
Key exclusion criteria
1)patient having double cancer
2)patient having interstitial pneumonia
3)patient having brain metastasis
4)patient having mental disorder
5)patient having uncontrollable heart disorder, pulmonary disorder or renal disorder
6)patient having bleeding tendency
7)patient having any allergic reaction to using drugs
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyotaka OKUNO |
Organization
Kindai University Faculty of Medicine
Division name
Department of Surgery
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL
072-366-0221
okuno@surg.med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichiro KAWAMURA |
Organization
Kindai University Faculty of Medicine
Division name
Department of Surgery
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL
072-366-0221
Homepage URL
kawamuraj@surg.med.kindai.ac.jp
Sponsor or person
Institute
Department of Surgery, Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kindai University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
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
近畿大学医学部附属病院外科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030046
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