UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025452 |
|---|---|
| Receipt number | R000029240 |
| Scientific Title | Phase I clinical study of a WT1-W10 peptide immunotherapy combined with standard treatment against diffuse midline glioma (WT1-TR-DMG). |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2019/07/01 11:32:11 |
* 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
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
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
vaccine@kochi-u.ac.jp
Sponsor or person
Institute
Cancer Vaccination Therapy Research Network Central Office, Department of Immunology, Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029240
