UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014855 |
|---|---|
| Receipt number | R000017261 |
| Scientific Title | A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients |
| Date of disclosure of the study information | 2014/08/14 |
| Last modified on | 2019/12/06 13:17:14 |
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Basic information
Public title
A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients
Acronym
A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients
Scientific Title
A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients
Scientific Title:Acronym
A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients
Region
| Japan |
Condition
Condition
Rare cancer or primary unknown cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Up to 4 from 31 candidate peptides, in which peptide-specific IgGs are detected before vaccination, are administered subcutaneously to rare cancer or primary unknown cancer patients.
The aim of this study is to investigate the correlation between immunological responses and overall survival.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Assesment of immunoresponses by measurement of peptide-specific IgGs and CTL responses by ELISPOT assay.
Key secondary outcomes
1. Analyze of correlation between immunological responses and overall survival.
2. Safety assessment
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
| Vaccine |
Interventions/Control_1
Personalized peptide vaccination are selected from 31 peptides restricted on higher peptide-specific IgG responses before vaccination.
Selected peptides are separately and subcutaneously injected(3.0mg/3.0ml/peptide) 1 week interval for 4 times and 2 weeks interval for 4 times (Total 8 times).
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 must be diagnosed as malignant tumor and divided into rare cancer or primary unknown cancer.
However, we don't make conditions that have evaluational lesion or clinical stage.
2)Patients must be at a score level of 0-1 of performance status(PS)(ECOG).
3)Patients must have IgG reactive to at least 2 peptides from 31 peptides restricted by HLA-class I.
4)Patients must be expected to survive more than 3 months.
5)Patients must satisfy the followings:
WBC >and= 2500/mm3
Lymphocyte >and= 1000/mm3
Hb >and= 8.0g/dL
Plt.>and= 80000/mm3
Serum Creatinine < and= 2.0 x upper limit of normal
Total Bilirubin < and= 2.0 x upper limit of normal
6)Patients must be more 18 year-old.
7)Written informed consent must be obtained from patients.
8)Patients must be positive for HLA-class I (-A2,-A24,-A26,-A3,-A11,-A31 or-A33)
Key exclusion criteria
The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency and disturbance of coagulation).
2)Patients with the past history of severe allergic reactions.
3)(Female) Patients who are pregnancy,lactation and hope the graviditas.
(male) Patient who do not agree prevebt pregnancy.
4)Patients who are judged inappropriate for entry to this clinical trial by doctor in charge.
Target sample size
200
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
Kokubu-machi 155-1, Kurume, Fukuoka 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
Kokubu-machi 155-1, Kurume, Fukuoka 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
Kurume University Cancer Vaccine Center
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）、久留米大学病院（福岡県）、内藤病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 14 | 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
| 2014 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 13 | Day |
Last modified on
| 2019 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017261
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