UMIN-CTR Clinical Trial

Basic information
Public title	A phase two clinical trial of the personalized peptide vaccine for standard therapy-resistant pediatric cancer patients
Acronym	A phase two trial of peptide vaccine for standard therapy-resistant pediatric cancer patients
Scientific Title	A phase two clinical trial of the personalized peptide vaccine for standard therapy-resistant pediatric cancer patients
Scientific Title:Acronym	A phase two trial of peptide vaccine for standard therapy-resistant pediatric cancer patients
Region	Japan

Condition
Condition	The pediatric patients who are resistant for standard therapy.
Classification by specialty	Hematology and clinical oncology Pediatrics Neurosurgery Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To testify the immune response, safety, and clinical effectiveness of personalized peptide vaccine for standard therapy-resistant pediatric cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Assessment of immune response by measurement of peptide specific IgG before and after peptide vaccination
Key secondary outcomes	Safety assessment (Observation of side effects) Clinical effectiveness(overall survival period)

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 standard therapy-resistant pediatric cancer patients, selected 4 personalized peptide vaccine are administered once a week for 6-8 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	3 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	1) standard therapy resistant cancer patients 2) Patients must be at a sore level of 0-1 of performance status (PS). 3) Patients must be positive for HLA-A2, HLA-A24, or HLA-A3 super type. 4) Patients must have IgG reactive to at least two of peptide of the candidate peptides restricted to the patients HLA types. 5) Patients must satisfy the followings : WBC >and= 2,500mm3 lymphocyte >and= 1,000/mm3 Hb >and= 8.0g/dl platelets >and= 80,000/mm3 serum creatinine <and= 2x upper limit of normal total bilirubin ,and= 2x upper limit of normal 6) Patients must be between 6 and 17 year-old. 7)Patients must be expected to survive more than 3 months. 8) Assent documents for 6-15 year-old patients and written informed consents for 16-17 year-old patients must be obtained. Moreover, informed consents are obtained from their caregivers. 9) Patients must be referred from pediatric cancer specialists.
Key exclusion criteria	The following patients must be excluded : 1) Patients with severe symptoms (active and severe infections, circulatory disease, respiratory disease, kidney disease,immunodeficiency, disturbance of coagulation). 2) Active double cancer (synchronous double cancer and meta-chronous double cancer within 3 disease-free years),excluding carcinoma in situ (lesions equal to intra-epithelial or intra-mucosal cancer) judged to have been cured with local treatment. 3) Patients with leukemia 4) Patients with the past history of severe allergic reactions. 5) Patients who hope for pregnancy 6) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 7) 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-city, 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-city,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）　Kurume University Cancer Vaccine Center (Fukuoka)

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 22 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	2016 Year 07 Month 22 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 22 Day
Last follow-up date	2020 Year 01 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	2016 Year 08 Month 01 Day
Last modified on	2019 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026986