UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013258 |
|---|---|
| Receipt number | R000015460 |
| Scientific Title | Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma |
| Date of disclosure of the study information | 2014/02/26 |
| Last modified on | 2014/05/15 12:04:46 |
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Basic information
Public title
Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Acronym
Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Scientific Title
Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Scientific Title:Acronym
Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Region
| Japan |
Condition
Condition
Malignant Glioma DIPG
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
his study is undertaken to evaluate anti-tumor effects of an immunotherapy using WT1 peptide against recurrent high grade glioma or diffuse intrinsic pontine glioma. Patients to be recruited must bear at least one copy of either HLA-A*0201, or A*2402.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
One year survival ratio
Key secondary outcomes
Effectiveness using RANO criteria,
Safty,
immunomonitaring to WT1 peptide
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
| Vaccine |
Interventions/Control_1
The patient is intradermally injected with 0.5 -2 mg of the HLA-A2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMN), the HLA A0201 restricted (mp126-134 RMFPNAPYL) modified WT1 peptide and WT1 helper peptide (p332-347 KRYFKLSHLQMHSRKH) emulsioned with Montanide ISA51 adjuvant.The WT1 vaccination was scheduled to be performed 6 times by-weekly intervals. Intradermally injection of WT1 vaccine will be continued for 1 year monthly.
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
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Pathologically confirmed high grade glioma except diffuse intrinsic pontine glioma
2) WT1 pathologically positive in HGG.
3) Recurrence confirmed with RANO criteria including radiological evaluations.
4) From 1 month after completion of radiotherapy
5) ECOG-PS: 0-3
6) Age:under 15 years old
7) HLA-A*24:02 and / or HLA-A*02:01
8) adequate organ functions
Neutrophils > 1,000
Platelets > 25, 000
Hb > 6.5
sCr : Age normal level upper limit 3 times
T-Bil : Age normal level upper limit 3 times
AST / ALT < 200 IU/L
9) Informed consent from legal guardian
Key exclusion criteria
1) active infectious diseases
2) Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on
3) Other severe problems unsuitable for this study active infectious diseases
4) Active other cancers except for carcinoma in situ treated completely
5) Past history of Myeloproliferative diseases, MSD
6) Received allogeneic stem cell transplantation
7) Severe Psychological Problems
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiko Hashii |
Organization
Osaka university graduate school of medicine
Division name
Pediatrics
Zip code
Address
2-2, Yamada-oka, Suita-city, Osaka, Japan
TEL
06-6879-3932
yhashii@ped.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiko Hashii |
Organization
Osaka university graduate school of medicine
Division name
Pediatrics
Zip code
Address
2-2, Yamada-oka, Suita-city, Osaka, Japan
TEL
06-6879-3932
Homepage URL
yhashii@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Ministries of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2014 | Year | 02 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 25 | Day |
Last modified on
| 2014 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015460
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