UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000030887