UMIN-CTR Clinical Trial

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