UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020306 |
|---|---|
| Receipt number | R000023420 |
| Scientific Title | A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes. |
| Date of disclosure of the study information | 2015/12/24 |
| Last modified on | 2017/11/10 15:44:57 |
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Basic information
Public title
A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes.
Acronym
Metoformin addition combination phase II clinical trial for the personalized peptide vaccine resistant patients.
Scientific Title
A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes.
Scientific Title:Acronym
Metoformin addition combination phase II clinical trial for the personalized peptide vaccine resistant patients.
Region
| Japan |
Condition
Condition
The patients whom a symptom aggravates without being complicated with diabetes of various personalized peptide vaccine phase II trial entries.
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
| Hematology and clinical oncology | Nephrology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Breast surgery | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is examination having immunoactive increase or not when used metformin together in personalized peptide vaccination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Assesment of immunoresponses by mesuremant of peptide specific IgGs before and after peptide vaccination with metformin.
Key secondary outcomes
Safety assessments
Clinical response(Overall 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
For the patients who were enrolled personalized peptide vaccination and judged as exacerbation at the end of 1st course of clincal trial, add metoformin 500mg/Day on peptide vaccination.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1)Patients who is not complicated with diabetes and HbA1c level is less than 6.5%
2)Patient who were enrolled personalized peptide vaccination and judged as exacerbation at the end of 1st course of clincal trial.
3)Patients must be a at a score level 0-2 of ECOG performance status.
4)Patients must have IgGs reactive to at least 2 of the candidate peptides restricted to the patient's HLA types.
5)Patients must be excepted to survive more than 3 months.
6)Patients must satisfy the followings:
WBC >and= 2500/mm3
Lymphocyte >and= 900/mm3
Hb >and= 8.0g/dL
Platelet >and= 50000/mm3
Serum Creatinine <and= 2.0mg/dL
Total Bilirubin <and= 2.5mg/dL
7)Patients must be more 18 years-old.
8)Written informed consent must be obtained from patients.
9)patients must be positive for HLA-class I A(-2,-24,-26,-3,-11,-31 or -33).
Key exclusion criteria
The following patients must be excluded.
1)Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation, et al.)
2)Patients with the past history of severe allergic reactions.
3)(Female)Pregnant or nursing patients.
(Male)Patients who do not accept contraception from the 1st vaccination to 70 days after last vaccination.
4)Patients who are judjed inappropriate for entry to this clinical trial by doctors.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
155-1 Kokubu-machi Kurume-city Fukuoka pref. Japan, 839-0863
TEL
0942-27-5210
yutani@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
155-1 Kokubu-machi Kurume-city Fukuoka pref. Japan, 839-0863
TEL
0942-27-5210
Homepage URL
http://www.med.kurume-u.ac.jp/med/cvc/
yutani@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Cancer Vaccine Center
Institute
Department
Personal name
Funding Source
Organization
None
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
久留米大学がんワクチンセンター（福岡県）Kurume University Cancer Vaccine Center（Fukuoka)
内藤病院（福岡県）Naitoh Hosp.(Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 24 | 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
| 2015 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 22 | Day |
Last modified on
| 2017 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023420
