UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of personalized peptide vaccination with transdermal adjuvant for cancer patients
Title of the study (Brief title)	Phase I study of personalized peptide vaccination with transdermal adjuvant
Region	Japan

Condition
Condition	malignant tumor
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and immunological effects of newly developed transdermal adjuvant with personalized peptide vaccination in patients with malignat tumor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of adeverse events using CTCAE v.4.0
Key secondary outcomes	Peptide-specigic IgG and CTL response after 6th vaccination

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	WHSC2-103 peptide is intradermaly injected and subsequently Hisamitsu adjuvant LA3% is pasted. The patient also received personalized peptide vaccin formula with Montanide ISA51VG. The vaccins are administered onece a week for 6weeks.
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	Patient meets all of the followings: 1) malignat tumor 2) more than 4-weeks past after the previous molecular targetting or chemotherapy 3) Performance status 0 or 1 4) HLA-A2 positive 5) IgG reactive to WHSC2-103 is positive and at least one more posiitive of vaccine panel peptides 6) expected life is more than 3 months 7) WBC more than 2,500/mm3 Lymphocyte more than 900/mm3 Hemoglobin more than 8.0 g/dL Platelet more than 50,000/mm3 Creatinin less than 2.0mg/dL Total bilirubin less than 2.5mg/dL 8) age more than 20 years old 9) acquisition of informed consent
Key exclusion criteria	Patient meets the followings: 1) under or have a plan of treatment with molecular tagetting or chemotherapy during this study 2) other severe diseases 3) severe allagic dideases 4) sensitive to adhesive plaster 5) woman with plegnancy or under milk feeding, man who is not accept contaception 6) doctor consider who is not appropriate for this study
Target sample size	10

Research contact person
Name of lead principal investigator	Akira Yamada
Organization	Kurume University
Division name	Research Center for Innovative Cancer Therapy
Address	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7744
Email	akiymd@med.kurume-u.ac.jp

Public contact
Name of contact person	not specified
Organization	Kurume University
Division name	Cancer vaccine center
Address	155-1 Kokubu-machi, Kurume, Fukuoka 839-0863, Japan
TEL	0942-27-5210
Homepage URL
Email	akiymd@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	HISAMITSU PHARMACEUTICAL CO.,INC
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 20 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 17 Day
Last modified on	2018 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035221