UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003506 |
|---|---|
| Receipt number | R000004249 |
| Scientific Title | Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma |
| Date of disclosure of the study information | 2010/04/19 |
| Last modified on | 2014/11/27 15:36:16 |
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Basic information
Public title
Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma
Acronym
Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma
Scientific Title
Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma
Scientific Title:Acronym
Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma
Region
| Japan |
Condition
Condition
Recurrent malignant glioma
Classification by specialty
| Medicine in general | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
1. Antitumor effect (RECIST)
2. Performance status (ECOG)
3. Progression-free survival time
4. Immune response to WT1
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 | Vaccine |
Interventions/Control_1
The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, 9--mer modified WT1 peptide (p235-243:CYTWNQMN) and 0.75mg, 1.5mg or 3mg of 16-mer WT1 helper peptide (p 332-347:KRYFKLSHLQMHSRKH) emulsified with Montanide ISA51 adjuvant.
The WT1 vaccination was scheduled to be performed 5 times at weekly intervals. If problems happen, the vaccination interval may be changed to two weeks. 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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as malignant glioma
2. Informed about his diagnosis
3. Not expected to make any further efficacy by standard treatment
4. WT1 expression in malignant cells
5. Having any one of HLA-class II type: HLA-DRB1*0405, 1501, 1502, 0803,HLA-DPB1*0901, 0501
6. Having evaluable diaseas
7. No chemotherapy/radiation has been performed within 4 weeks and no BRM therapy has been performed within 3 weeks before the start of vaccination.
8. Aged 16 and over, and 79 and under
9. Performance status (ECOG) 0-1
10. Meet the following criteria for organ functions
1) Neutrophil more than 1,500/microliter, Platelet more than 75,000/microliter, Hemoglobin more than 8g/dl
2) Serum creatinine less than 2.0 mg/dL
3) Serum bilirubin less than 1.5 folds of the upper normal limit
4) Serum AST/GOT less than 4 folds of the upper normal limit
5) Serum Albumin more than 2.5g/dl
6) Arterial oxygen saturation more than 94% in room air
11. Pleural effusion, ascites and pericardial effusion are not detected or
controlled.
12. Survival period is expected more than 3 months
13. Informed consent has been obtained
Key exclusion criteria
1. There is deep-seated active infection.
2,3. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.Patients who have complications that are considered inappropriate for the trial.
4. Dependent on total parenteral nutrition(TPN)
5. There are other malignancies.
6. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD).
7. Post allogeneic hematopoietic stem cell transplantation
8. Pregnant or lactating woman
9. There is severe psychiatric disorder.
10. 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 | Haruo Sugiyama |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Functional Diagnosis
Zip code
Address
1-7, Yamada-oka, Suita City, Osaka , Japan
TEL
06-6879-2593
sugiyama@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tsuboi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cancer Immunotherapy
Zip code
Address
2-2, Yamada-oka, Suita City, Osaka , Japan
TEL
06-6879-3676
Homepage URL
tsuboi@cit.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
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
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
| 2010 | Year | 04 | Month | 19 | 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
| 2010 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 19 | Day |
Last modified on
| 2014 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004249
