UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase two clinical trial of the personalized peptide vaccine for the recurrence prevention in pediatric cancer patients
Title of the study (Brief title)	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	Keiko Oda
Organization	Kurume University
Division name	Cancer vaccine center
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	Keiko Oda
Organization	Kurume University
Division name	Cancer vaccine center
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 12 Month 01 Day
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

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Publication of results	Unpublished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