UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030854 |
|---|---|
| Receipt number | 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 12:51:43 |
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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
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
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035221
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
