UMIN-CTR Clinical Trial

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