Unique ID issued by UMIN | UMIN000006970 |
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Receipt number | 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 15:14:44 |
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-
A placebo controlled phase III double blind study of ITK-1
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-
A placebo controlled phase III double blind study of ITK-1
Japan |
Glioblastoma
Neurosurgery |
Malignancy
NO
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)
Safety,Efficacy
Confirmatory
Phase III
Overall survival
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
NO
Central registration
2
Treatment
Medicine |
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.
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.
18 | years-old | <= |
75 | years-old | > |
Male and Female
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
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
110
1st name | |
Middle name | |
Last name | Mizuhiko Terasaki |
Kurume University Hospital
Neurosurgery
Asahi-machi 67, Kurume, fukuoka 830-0011
0942-35-3311
neuro@terasaki-nsc.com
1st name | |
Middle name | |
Last name | Akira Yamada |
Kurume University
Research center of Innovative Cancer Therapy
Asahi-machi 67, Kurume, fukuoka 830-0011
0942-31-7744
akiymd@med.kurume-u.ac.jp
Kurume University Cancer Vaccine Center
The Ministry of Health, Labor and Welfare of Japan
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
YES
JapicCTI-111726
Japan Pharmaceutical Information Center
2011年11月17日、2011年12月19日、2012年1月18日
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)
2012 | Year | 01 | Month | 04 | Day |
Unpublished
Completed
2011 | Year | 09 | Month | 30 | Day |
2011 | Year | 09 | Month | 30 | Day |
2011 | Year | 12 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2011 | Year | 12 | Month | 28 | Day |
2019 | Year | 10 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008230
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