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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026965
Receipt No. 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

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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
Email 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
Email tsuboi@cit.med.osaka-u.ac.jp

Sponsor
Institute Department of Cancer Immunotherapy, Osaka University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030887

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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