UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002419 |
|---|---|
| Receipt number | 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 15:09:39 |
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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
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
vaccine@kochi-u.ac.jp
Sponsor or person
Institute
Cancer Vaccination Therapy Research Network, Department of Immunology,
Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002963
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