UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Novel treatment for refractory neuroblastoma by using poliovirus; phase I clinical trial
Title of the study (Brief title)	Novel treatment for refractory neuroblastoma by using poliovirus; phase I clinical trial
Region	Japan

Condition
Condition	refractory neuroblastoma
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	safety and efficacy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety (paralysis) and efficacy (anti-tumor effect) at 6 months after administration
Key secondary outcomes

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
Interventions/Control_1	intratumoral administration of poliovirus
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 months-old <=
Age-upper limit	120 months-old >
Gender	Male and Female
Key inclusion criteria	refractory neuroblastoma
Key exclusion criteria	patients who have paralysis
Target sample size	3

Research contact person
Name of lead principal investigator	Hidemi Toyoda
Organization	Mie University Hospital
Division name	Pediatrics
Address	2-174 Edobashi, Tsu
TEL	059-232-1111
Email	htoyoda@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Hidemi Toyoda
Organization	Mie University Hospital
Division name	Pediatrics
Address	2-174 Edobashi, Tsu
TEL	059-232-1111
Homepage URL
Email	htoyoda@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 15 Day
Anticipated trial start date	2009 Year 12 Month 15 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 11 Month 03 Day
Last modified on	2018 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034063