UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes.
Title of the study (Brief title)	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 Obsterics 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	Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Address	155-1 Kokubu-machi Kurume-city Fukuoka pref. Japan, 839-0863
TEL	0942-27-5210
Email	yutani@med.kurume-u.ac.jp

Public contact
Name of contact person	Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
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/
Email	yutani@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University Cancer Vaccine Center
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023420