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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030854
Receipt No. R000035221
Scientific Title Phase I study of personalized peptide vaccination with transdermal adjuvant for cancer patients
Date of disclosure of the study information 2018/01/18
Last modified on 2018/01/17

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Basic information
Public title Phase I study of personalized peptide vaccination with transdermal adjuvant for cancer patients
Acronym Phase I study of personalized peptide vaccination with transdermal adjuvant
Scientific Title Phase I study of personalized peptide vaccination with transdermal adjuvant for cancer patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Akira Yamada
Organization Kurume University
Division name Research Center for Innovative Cancer Therapy
Zip code
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
1st name
Middle name
Last name not specified
Organization Kurume University
Division name Cancer vaccine center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2015 Year 10 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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