UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030249
Receipt No. R000034543
Scientific Title A phase two clinical trial of the personalized peptide vaccine for the recurrence prevention in pediatric cancer patients
Date of disclosure of the study information 2017/12/07
Last modified on 2019/01/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A phase two clinical trial of the personalized peptide vaccine for the recurrence prevention in pediatric cancer patients
Acronym A phase two trial of peptide vaccine for the recurrence prevention in pediatric cancer patients
Scientific Title A phase two clinical trial of the personalized peptide vaccine for the recurrence prevention in pediatric cancer patients
Scientific Title:Acronym A phase two trial of peptide vaccine for the recurrence prevention in pediatric cancer patients
Region
Japan

Condition
Condition Pediatric cancer patients
Classification by specialty
Hematology and clinical oncology Pediatrics Orthopedics
Neurosurgery Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To testify the clinical effectiveness of personalized peptide vaccine for tumor recurrence prevention in pediatric cancer patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes the recurrence of the original tumor,judgement after six months from the beginning of the peptide vaccination
Key secondary outcomes assessment of immune response by measurement of peptide specific IgG before and after peptide 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 For the pediatric cancer patients who underlying diseases are controlled and hope for
recurrence prevention, we give selected four peptide vaccine once a month for six 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
4 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria 1) Pediatric cancer patients (children or adults who are diagnosed as having malignancy when they were under 15-year old)
2) Patients must be at a score level of 0-1 of performance status (PS).
3) Patients must be positive for HLA-A2,HLA-A24, HLA-26, HLA-A3,HLA-A11,HLA-A31,or HLA-A33 super types.
4) Patients must have IgG reactive to at least two of the candidate peptides restricted to the patients HLA types.
5) Patients must satisfy the following :
WBC >and= 2,500/mm3
Lymphocytes >and= 900/mm3
Hb >and= 8.0g/dl
platelets >and= 80,000/mm3
serum creatinine <and= 2xupper limit of normal
total bilirubin <and= 2x upper limit of normal
6) Patients must be between 4 and 30 year-old.
7) Patients must be expected to survive more than 3months.
8) Assent documents for 4-15 year-old patients and written informed consents for more than 16 year-old patients must be obtained.Moreover, informed consents are obtained from their caregivers.
9) Patients must be referred from cancer specialists.
Key exclusion criteria The following patients must be excluded:
1) Patients with severe symptoms (active and severe infections, circulatory diseases, respiratory diseases, kidney diseases, immunodeficiency, disturbance of coagulation).
2) Active double cancer (synchronous double cancer and meta-chronous double cancer within three disease-free years), excluding carcinoma in situ (lesions equal to intra-epithelial or intra-mucosal cancer), judging to have been cured with local treatment.
3) Patients with the past history of severe allergic reactions.
4) Patients who hope for pregnancy
5) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
6) Patients who are judged inappropriate for entry to this trial by doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Oda
Organization Kurume University
Division name Cancer vaccine center
Zip code
Address #155-1,Kokubu-machi ,Kurume,Fukuoka, Japan, 839-0863
TEL 0942-27-5210
Email oda_keiko@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Oda
Organization Kurume University
Division name Cancer vaccine center
Zip code
Address #155-1,Kokubu-machi ,Kurume,Fukuoka, Japan, 839-0863
TEL 0942-27-5210
Homepage URL
Email oda_keiko@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)

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 久留米大学がんワクチンセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 07 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 Terminated
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 11 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
2017 Year 12 Month 04 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034543

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.