UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006970
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kurume University Cancer Vaccine Center

Institute

Department

Personal name



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

Value
https://center6.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