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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010602
Receipt No. R000012389
Scientific Title Randomized phase IIb/III trial of autologous tumor vaccine with temozolomide for newly diagnosed glioblastoma.
Date of disclosure of the study information 2013/04/26
Last modified on 2014/10/28

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Basic information
Public title Randomized phase IIb/III trial of autologous tumor vaccine with temozolomide for newly diagnosed glioblastoma.
Acronym AFTV-GBM-PIIb/III
Scientific Title Randomized phase IIb/III trial of autologous tumor vaccine with temozolomide for newly diagnosed glioblastoma.
Scientific Title:Acronym AFTV-GBM-PIIb/III
Region
Japan

Condition
Condition newly diagnosed glioblastoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of autologous tumor vaccine to prevent recurrence and/or cure residual tumor for patients with newly diagnosed glioblastoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes overall survival
Key secondary outcomes 1) Cause-specific survival
2) Progression-free survival
3) Tumor-regression rate, disease-control rate
4) QOL
5) Neurological improvement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 vaccine
Interventions/Control_2 non vaccine
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
16 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) 16 to 75 years of age.
2) Newly diagnosed and histologically confirmed glioblastoma (WHO grade IV) in supratentrial brain without dissemination.
3) Maximum surgical resection was performed.
4) Enough mass of tumor reserved as fixed specimen.
5) Karnofsky performance scale is equal to or more than 60 %, and life expectancy expected at least 3months.
6) Standard radiotherapy in 60 Gy will be performed.
7) Patient informed his/her diagnosis, and has enough ability to comprehend and consent to the study.
8) Vaccination and follow-up will perform under the institutions.
Key exclusion criteria 1) Patients who have been administered or are taking corticosteroid.
2) Patients who implantated of carmustine wafers in the surgical cavity.
3) Patients with high intracranical pressure.
4) Patients with severe myelosupression.
5) Patients with severe complication including hematopathy
6) Patients with malignant tumor or cancer except malignant glioma.
7) Pregnant or nursing woman, or woman willing to be pregnant.
8) Patients participate in other study during or within 6 months before temozolomide administration in this study.
9) Patients who has HBV or HCV.
10) Other reasons for exclusion
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Muragakli
Organization Tokyo Women's Medical University, Graduate School of Medicine
Division name Faculty of Advanced Techno-Surgery, Institute of Advanced Biomedical Engineering & Science, Dep. of Neurosurgery, Neurological Institute
Zip code
Address 8-1 Kawada-cho Shinjuku-ku Tokyo 162-8666 Japan
TEL 03-5367-9945
Email ymuragaki@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Maruyama
Organization Tokyo Women's Medical University
Division name Dep. of Neurosurgery, Neurological Institute
Zip code
Address 8-1 Kawada-cho Shinjuku-ku Tokyo 162-8666 Japan
TEL 03-3353-8111
Homepage URL
Email tmaruyama@nij.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Cell Medicine Cooperation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京女子医科大学附属病院(東京都)、筑波大学附属病院(茨城県)、大分大学附属病院(大分県)、日赤医療センター(東京都)、熊本大学(熊本県)、東北大学(宮城県)、京都大学(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 26 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
2012 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 26 Day
Last modified on
2014 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012389

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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