UMIN-CTR Clinical Trial

Basic information
Public title	Phase I clinical study of a WT1-W10 peptide immunotherapy combined with standard treatment against diffuse midline glioma (WT1-TR-DMG).
Acronym	WT1-W10 immunotherapy against DMG (WT1-TR-DMG)
Scientific Title	Phase I clinical study of a WT1-W10 peptide immunotherapy combined with standard treatment against diffuse midline glioma (WT1-TR-DMG).
Scientific Title:Acronym	WT1-W10 immunotherapy against DMG (WT1-TR-DMG)
Region	Japan

Condition
Condition	glioblastoma multiforme
Classification by specialty	Pediatrics Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aims at evaluating the safety of an immunotherapy using WT1-W10 peptide combined with the standard radio-chemotherapy using temozolomide against juvenile diffuse midline glioma. An addition of bevacizumab is permissible, but evaluation will be made separately. As an auxiliary subject of observation includes optimization of dose of the immunogen.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Degree and frequency of adverse events (> grade 3)
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	Standard radio-chemotherapy using wither 1) or 2) below will be combined. 1)Temozolomide (TMZ) + WT1-W10 peptide 2)Temozolomide (TMZ) + bevacizumab (BV) + WT1-W10 peptide 1.WT1-W10 peptide immunotherapy 3.0 mg WT1-W10 peptide in 300micro-l of 5% glucose is mixed with the inactivated 5x108 Bordetella pertussis whole cell vaccine in 100micro-l saline and injected intra-dermally into 4 sites (100micro-l per site) near the sub-clavicular and axial lymph nodes. Immunization is repeated every week. If the erythema which usually emerge 24-48 hours after the immunization, exceed 5 cm in diameter dose of the immunogen will be reduced to 1/2 from the next injection. 2.Temozolomide By following the standard protocol provided by the manufacturer 75 mg/m2 of TMZ was ingested every day for 5 days a week and for 6 weeks. After 4 weeks of withdrawal, 150 (up to 200) mg/m2 of TMZ was taken every day for 5 days followed by 3 week-withdrawal. This 28-day interval of TMZ administration is repeated. 3.Bevacizumab 5 mg/Kg/week of BV was administered intravenously every 2-3 weeks. Synchronization with the schedule of TMZ is not necessary.
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)Diagnosed as diffuse midline glioma (DMG) and competent to receive standard radio-chemotherapy using TMZ. A further inclusion of BV is permissive. 2)3 - 17 years of age 3)Carrying one or two of HLA-A*24:02, A*02:01, A*02:06, A*02:07 genes 4)The tumor overexpresses WT1 protein (optional for the cases where tumor tissue has been obtained) 5)Karnofsky Index > 60% or performance status : 0-2 6)Expected survival > 3 months 7)No serious impairment of the heart, lung, liver, kidney and bone marrow 8)Without serious diseases aside from DMG, no double cancers including malignancies of the hematopoietic organs 9)Written consent from the parents and/or patient is obtained.
Key exclusion criteria	One or more of the following criteria leads to exclusion of the subject. 1)Uncontrollable infections, including active tuberculosis 2)Severe comorbidities (e.g. malignant hypertension, severe congestive heart disease, severe ischemic heart disease, myocardial infarction within 3 months, end-stage liver insufficiency, uncontrollable diabetes mellitus, severe pneumonitis etc.) 3)After the bone marrow implantation 4)Severe psychological disorders 5)Being enrolled in other clinical trials 6)Once enrolled in this study, but was disqualified for some reasons (Double enrollment is prohibited.) 7)Disqualified by the doctors due to some medical, psychological and/or social problems
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mikiya Fujieda
Organization	Kochi Medical School
Division name	Department of Pediatrics
Zip code
Address	Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
TEL	088-866-5811
Email	fujiedam@kochi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yu Kawanishi
Organization	Kochi Medical School
Division name	Department of Pedicatrics
Zip code
Address	Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
TEL	088-880-2355
Homepage URL
Email	vaccine@kochi-u.ac.jp

Sponsor
Institute	Cancer Vaccination Therapy Research Network Central Office, Department of Immunology, Kochi Medical School
Institute
Department

Funding Source
Organization	NEC Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 04 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 12 Month 28 Day
Date of IRB	2017 Year 01 Month 05 Day
Anticipated trial start date	2017 Year 01 Month 05 Day
Last follow-up date	2021 Year 12 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 12 Month 28 Day
Last modified on	2019 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029240