UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026965 |
|---|---|
| Receipt number | R000030887 |
| Scientific Title | Phase II clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with glioblastoma. |
| Date of disclosure of the study information | 2017/04/12 |
| Last modified on | 2019/04/15 13:36:39 |
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Basic information
Public title
Phase II clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with glioblastoma.
Acronym
Phase II clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with glioblastoma.
Scientific Title
Phase II clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with glioblastoma.
Scientific Title:Acronym
Phase II clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with glioblastoma.
Region
| Japan |
Condition
Condition
Glioblastoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Efficacy and safety of adjuvant therapy for primary glioblastoma using WT1 peptide vaccine in combination with temozolomide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival time
Key secondary outcomes
1) Safety
2) Overall survival time
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 |
Interventions/Control_1
We use three kinds of WT1 peptides. The patient is intradermally injected with the mixture of WT1 peptides emulsified with Montanide ISA51 adjuvant.The WT1 vaccination was scheduled to be started at the timing of maintenance temozolomide and performed 22 times at 2~8 week intervals between 2 years.
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as malignant glioma
2. Informed about his diagnosis
3. WT1 expression in malignant cells
4. Dissemination negative
5. HLA-A*2402 or HLA-A*0201 positive
6. Require no evaluable diaseas
7. Aged 20 and over, and 79 and under
8. Performance Status (ECOG) 0-2
9. Followed by Operation, Radiation and Temozolomide
10. Meet the following criteria for organ functions
1)Neutrophil more than 1,000/microliter, Platelet more than 50,000/microliter, Hemoglobin more than 8g/dl
2) Serum creatinine less than 2.0 mg/dL
3) Serum bilirubin less than 2.0 mg/dL
4) Serum AST/GOT less than 100IU/L
5) Serum Albumin more than 2.5g/dl
6) Arterial oxygen saturation more than 94% in room air
11. Survival period is expected more than 3 months
12. 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. Allergic histry for dacarbazine
10. Responsible doctors judged the patient inappropriate for the trial
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tsuboi |
| Middle name | |
| Last name | Akihiro |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cancer Immunotherapy
Zip code
565-0871
Address
2-2, Yamada-oka, Suita City, Osaka , Japan
TEL
06-6879-3676
tsuboi@cit.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuboi |
| Middle name | |
| Last name | Akihiro |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cancer Immunotherapy
Zip code
565-0871
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
Donation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Academic Clinical Research Center of Osaka University Hospital
Address
2-2, Yamada-oka, Suita City, Osaka , Japan
Tel
06-6233-3188
acr-jim@dmi.med.osaka-u.ac.jp
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 | 04 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2017 | Year | 04 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030887
