UMIN-CTR Clinical Trial

Basic information
Public title	Immunotherapy using WT1 peptide against recurrent glioblastoma multiforme: A phase I/II study.
Acronym	Immunotherapy using WT1 peptide against recurrent glioblastoma multiforme.
Scientific Title	Immunotherapy using WT1 peptide against recurrent glioblastoma multiforme: A phase I/II study.
Scientific Title:Acronym	Immunotherapy using WT1 peptide against recurrent glioblastoma multiforme.
Region	Japan

Condition
Condition	glioblastoma multiforme
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study is undertaken to evaluate the safety and anti-tumor effects of an immunotherapy using WT1 peptide against recurrent glioblastoma multiforme. Patients to be recruited must bear at least one copy of either HLA-A*0201, -A*0206 or –A*2402 gene and their tumors have resisted the conventional anti-tumor therapies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of side effects (phase I) Progression-free survival (phase II)
Key secondary outcomes	Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses

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	3.0 mg of WT1 peptide and adjuvant agent will be administrated intradermally. The administration interval is essentially every week.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Treatment-failure glioblastoma multiforme patients who have been histologically diagnosed as glioblastoma multiforme. 2) Patients must bear at lease one copy of either HLA-A*2402, -A*0201, or -A*0206 gene. 3) The tumor tissue is positibe by stained for WT1 by immunohistochemistry. 4) The patients' Karnofsky Index should be 60% or more(performance status(ECOG should be 0-2). 5) Expected survival time should be three months or greater. 6) Sufficient function of important organs including heart, lung, liver, kidney and bome marrow. And patients must satisfy the followings: Creatinin <= 1.2 mg/dl BUN <= 24 mg/dl Total Bilirubin <= 1.3 mg/dl AST <= 50 U/l ALT <= 50 U/l Neutrophil >= 1,600/mm3 Platelet >= 100,000/mm3 Hemoglobin >= 10.5g/dl ECG: no serious object SpO2 >= 94% (room air) 7) Patients without additional malignant diseases 8) Written informed consents are obtained from patients after giving sufficient explanations and obtaining their understandings about disease conditions.
Key exclusion criteria	The following patients must be excluded: 1) Patients with uncontrollable infectious disease (including active Tuberculosis). 2) Patients with severe symptoms (malignant hypertension, severe congestive heart failure, severe colonary insufficiency, Myocardial Infarction within three months lately, terminal phase liver cirrhosis, uncontrollable Diabetes Mellitus, severe Pulmonary Fibrosis, active interstitial pneumonia, etc.). 3) Patients previously treated with Allogeneic bone marrow transplantation. 4) Patients who are pregnant and/or breast feeding, 5) Patients with severe psychiatric disease. 6) Patients who participate in any other clinical trial. 7) Patients who previously participated in this clinical trial. 8) Any patients disqualified by a study physician because of medical, psychological, or any other factors.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsuya Ueba
Organization	Kochi Medical School
Division name	Department of Neurosurgery
Zip code
Address	1662 Ochi-koh, Ochi-cho, Takaoka-gun, Kochi
TEL	088-880-2397
Email	vaccine@kochi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Keiko Udaka
Organization	Kochi Medical School
Division name	Department of Neurosurgery
Zip code
Address	1662 Ochi-koh, Ochi-cho, Takaoka-gun, Kochi
TEL	088-880-2397
Homepage URL
Email	vaccine@kochi-u.ac.jp

Sponsor
Institute	Cancer Vaccination Therapy Research Network, Department of Immunology, Kochi Medical School
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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
Address
Tel
Email

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	2009 Year 06 Month 01 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	2009 Year 03 Month 26 Day
Date of IRB	2009 Year 09 Month 03 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 06 Month 01 Day
Last modified on	2019 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002471