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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006970
Receipt No. R000008230
Scientific Title A placebo controlled phase III double blind study of ITK-1 -The efficacy and safety evaluation of ITK-1 in Temozolomide refractory Glioblastoma patients with HLA-A24 positive-
Date of disclosure of the study information 2012/01/04
Last modified on 2019/10/30

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Basic information
Public title A placebo controlled phase III double blind study of ITK-1
-The efficacy and safety evaluation of ITK-1 in Temozolomide refractory Glioblastoma patients with HLA-A24 positive-
Acronym A placebo controlled phase III double blind study of ITK-1
Scientific Title A placebo controlled phase III double blind study of ITK-1
-The efficacy and safety evaluation of ITK-1 in Temozolomide refractory Glioblastoma patients with HLA-A24 positive-
Scientific Title:Acronym A placebo controlled phase III double blind study of ITK-1
Region
Japan

Condition
Condition Glioblastoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective is to evaluate the efficacy and safety of ITK-1 comparing with placebo in Temozolomide refractory Glioblastoma patients with HLA-A24 positive under the best supportive care(BSC)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes 1. Survival rate at 12 months
2. Objective tumor response
3. Objective tumor response(Macdonald's Criteria)
4. Progression-free survival
5. 6-month progression-free survival
6. Anti-peptide antibody titer
7. Cytotoxic T lymphocyte activity
8. Frequency of adverse reactions and adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ITK-1 group : Peptide vaccine (3mg/1.5mL) with selected 2 to 4 are injected subcutaneously once weekly in total 12 times at the first course. At the second to sixteen course, peptide vaccine is administered biweekly.
Interventions/Control_2 Placebo group : Placebo(1.5mL) with selected 2 to 4 are injected subcutaneously once weekly in total 12 times at the first course. At the second to sixteen course, placebo is administered biweekly.
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
18 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Written Informed Consent (If signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient in permitted)
2)HLA-A24 positive
3)Showing immune response to 2 or more out of 12 ITK-1 peptides
4)Diagnosed Glioblastoma histopathologically
5)Disease progression confirmed regardless of treated with standard radiotherapy and had received temozolomide
6)Measurable lesions (>=5*5mm)
7)ECOG performance status of 0-2 (3 is acceptable if limited to neural symptoms)
8)Expected to survive more than 3 months
9)Adequate organ function
Key exclusion criteria 1)Infratentorial tumor, gliomatosis cerebri, meningeal dissemination
2)Hypersensitivity to mineral oil or mannitol oleate or contrast medium for MRI
3)Severe complications
4)Active multiple cancers
5)Received ITK-1 in the m for MRI past
6)Entry to the other clinical trial within 2 months prior to entry to this study
7)Difficult to participate in this trial because of psychiatric symptoms
8)Pregnant or breast-feeding patients
9)Any other cases who are judged as being ineligible for this study by physician
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mizuhiko Terasaki
Organization Kurume University Hospital
Division name Neurosurgery
Zip code
Address Asahi-machi 67, Kurume, fukuoka 830-0011
TEL 0942-35-3311
Email neuro@terasaki-nsc.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamada
Organization Kurume University
Division name Research center of Innovative Cancer Therapy
Zip code
Address Asahi-machi 67, Kurume, fukuoka 830-0011
TEL 0942-31-7744
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare of Japan
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 YES
Study ID_1 JapicCTI-111726
Org. issuing International ID_1 Japan Pharmaceutical Information Center
Study ID_2
Org. issuing International ID_2
IND to MHLW 2011年11月17日、2011年12月19日、2012年1月18日

Institutions
Institutions 久留米大学病院(福岡県)
埼玉医科大学国際医療センター(埼玉県)
埼玉医科大学病院(埼玉県)
国立がん研究センター中央病院(東京都)
広島大学病院(広島県)
国立病院機構京都医療センター(京都府)
山口大学医学部附属病院(山口県)
福岡大学病院(福岡県)
宮崎大学医学部附属病院(宮崎県)
東北大学病院(宮城県)
北海道大学病院(北海道)
香川大学医学部附属病院(香川県)
杏林大学医学部付属病院(東京都)
藤田保健衛生大学病院(愛知県)
岡山大学病院(岡山県)
高知大学医学部附属病院(高知県)
北里大学病院(神奈川県)
京都大学医学部附属病院(京都府)
名古屋大学医学部附属病院(愛知県)
山形大学医学部附属病院(山形県)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 04 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
2011 Year 09 Month 30 Day
Date of IRB
2011 Year 09 Month 30 Day
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2017 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
2011 Year 12 Month 28 Day
Last modified on
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008230

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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