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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002419
Receipt No. R000002963
Scientific Title Immunotherapy using WT1 peptide with surgical treatment, irradiation therapy, and Temozolomide administration against glioblastoma multiforme: A phase I/II study.
Date of disclosure of the study information 2009/09/01
Last modified on 2013/09/04

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Basic information
Public title Immunotherapy using WT1 peptide with surgical treatment, irradiation therapy, and Temozolomide administration against glioblastoma multiforme: A phase I/II study.
Acronym Immunotherapy using WT1 peptide with surgical treatment, irradiation therapy, and Temozolomide against glioblastoma multiforme
Scientific Title Immunotherapy using WT1 peptide with surgical treatment, irradiation therapy, and Temozolomide administration against glioblastoma multiforme: A phase I/II study.
Scientific Title:Acronym Immunotherapy using WT1 peptide with surgical treatment, irradiation therapy, and Temozolomide against 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 with surgical treatment, irradiation therapy, and Temozolomide administration against glioblastoma multiforme.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

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 Concurrent therapy with following methods.
(1)surgical treatment
(2)irradiation therapy;
2Gy/fraction/day, 30fractions, total dose of 60Gy
(3)Temozolomide(TMZ)
1st regimen is;
TMZ(75mg/m2) day1-42 orally.
after 4 weeks interval, 2nd regimen is followed as;
TMZ(150-200mg/m2) day1-5 orally, every 4 weeks.
(4)WT1 peptide vaccination immunotherapy
3.0mg of WT1 peptide 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) Glioblastoma multiforme patients who have not performed tumor-specific pretreatment.
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 45

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 tueba@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yu Kawanishi
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 Japan

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 09 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 Open public recruiting
Date of protocol fixation
2009 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 09 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 09 Month 01 Day
Last modified on
2013 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002963

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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