UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013257 |
|---|---|
| Receipt number | R000015466 |
| Scientific Title | Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma. |
| Date of disclosure of the study information | 2014/02/26 |
| Last modified on | 2014/02/25 11:48:27 |
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Basic information
Public title
Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma.
Acronym
Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma
Scientific Title
Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma.
Scientific Title:Acronym
Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma
Region
| Japan |
Condition
Condition
High grade glioma, Diffuse intrinsic pontine glioma
Classification by specialty
| Pediatrics | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Safty
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Safty
Key secondary outcomes
progression free survival time
all over survival time
Immunomonitering
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
The patient is intradermally injected with 0.5-2.0 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMN), HLA-A*0201-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMN) and 0.5-2.0 mg of 16-mer WT1 helper peptide (p332-347:KRYFKLSHLQMHSRKH) emulsified with Montanide ISA51 adjuvant.
The WT1 vaccination was scheduled to be performed 5 times at bi-weekly intervals. The safety are evaluated by the NCI-CTC criteria from 1 to 2 weeks after 5th WT1 vaccination.
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. Diagnosed as malignant glioma or diffuse intrinsic glioma
2. Performance status (ECOG) 0-3
3. Meet the following criteria for organ functions
Neutrophil more than 1,000/microliter, Platelet more than 25,000/microliter, Hemoglobin more than 6.5 g/dl
Serum creatinine less than 2.0 mg/dL
Serum bilirubin less than 3 folds of the upper normal limit
Serum AST/GOT less than 3 folds of the upper normal limit
Serum Albumin more than 2.5g/dl
Arterial oxygen saturation more than 94% in room air
4. Informed consent has been obtained from legal guardian.
5. HLA 2402 and or 0201
6. WT1 expression in malignant cells in high grade glioma
Key exclusion criteria
1. There is deep-seated active infection.
2. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.
3. Patients who have complications that are considered inappropriate for the trial.
4. There are other malignancies.
5. There are hematopoietic stem cell disorders such as MDS.
6. Post allogeneic hematopoietic stem cell transplantation
7. Responsible doctors judged the patient inappropriate for the trial
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
areken@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
areken@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Ministry 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 | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015466
