UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010602 |
|---|---|
| Receipt number | 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 | 2021/09/15 18:08:53 |
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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
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
tmaruyama@nij.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
63
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
| 2012 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 10 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 26 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012389
