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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023806
Receipt No. R000027429
Scientific Title Immunotherapy with fusions of glioma cells, glioma initiating cells, and dendritic cells for patients with malignant glioma
Date of disclosure of the study information 2016/09/01
Last modified on 2017/03/01

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Basic information
Public title Immunotherapy with fusions of glioma cells, glioma initiating cells, and dendritic cells for patients with malignant glioma
Acronym Dendritic cell-based immunotherapy for patients with malignant glioma
Scientific Title Immunotherapy with fusions of glioma cells, glioma initiating cells, and dendritic cells for patients with malignant glioma
Scientific Title:Acronym Dendritic cell-based immunotherapy for patients with malignant glioma
Region
Japan

Condition
Condition Malignant glioma (Grade 3 or 4 glioma in the WHO criteria)
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficacy of immunotherapy with fusion cells (FCs) of glioma cells, glioma initiating cells, and dendritic cells for patients with malignant glioma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year overall survival (OS) rate (a group of initially diagnosed grade 4 glioma)
3-year OS rate (a group of initially diagnosed grade 3 glioma)
1-year OS rate (a group of recurrent glioma)
Key secondary outcomes 1-year progression free survival (PFS) rate (a group of initially diagnosed grade 4 glioma)
2-year PFS rate (a group of initially diagnosed grade 3 glioma)
6-month PFS rate (a group of recurrent glioma)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 The FCs of glioma cells, glioma initiating cells, and dendritic cells will be inoculated intradermally at the cervical region. FC-inoculation will be repeated 3~10 times in each 28-day cycle. This therapy will be combined with a standard adjuvant therapy for malignant glioma.
Interventions/Control_2
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 <Tentative inclusion criteria>
Patients will be tentatively enrolled in this clinical trial, when they satisfy the following tentative inclusion criteria.
1) A patient who is suspected a malignant glioma by a MRI or CT image, and needs to receive a surgical tumor resection.
2) A patient who is tolerable to receive gathering peripheral blood mononuclear cells by an apheresis method.
3)A patient who satisfies following criteria without functional failure of major organs, such as heart, lung, liver, kidney, and bone marrow etc.
WBC > 2,500/microL
Platelet > 75,000/microL
Hb > 9.0/dL
Serum creatinine < 1.5mg/dL
Total bilirubin < 2.0mg/dL
AST, ALT < 100U/L
4)A patient who has grade 0 to 2 of the Performance Status.
5)A patient who is suspected to be alive for more than 3 months.
6)A patient who does not have multiple primary cancer.

<Final inclusion criteria>
Tentatively enrolled patients will be truly enrolled as a subject of this clinical trial, when they satisfy the following final inclusion criteria.
1)A patient who is histologically proven malignant glioma (Grade 3 or 4 glioma in the WHO criteria).
2)A patient who has autologous cultured tumor cells available to fuse with dendritic cells.
Key exclusion criteria 1)A patient who has an allergy to biological medicines.
2)A patient who has a past or current history of autoimmune disease.
3)A patient who has positive of HBs antigen, HIV antibody, HCV antibody, or HTLV antibody.
4)A patient who has sever immune deficiency.
5)A patient who is administrated steroids for a long period, and is difficult to stop it.
6)A patient who has sever infectious disease.
7)A patient who has sever lung disease (Class 3 or more in the Hugh-Jones classification).
8)A patient who has sever heart disease (Class 3 or more in the NYHA).
9)A patient who has uncontrollable diabetes.
10)A pregnant or lactating patient.
11)A patient who is involved in other clinical trials.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuharu Akasaki
Organization Jikei University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 3-25-8 Nishishinbashi Minato-ku, Tokyo
TEL 03-3433-1111
Email akasaki@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuharu Akasaki
Organization Jikei University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 3-25-8 Nishishinbashi Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email akasaki@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
2016 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
2021 Year 08 Month 31 Day
Date trial data considered complete
2021 Year 08 Month 31 Day
Date analysis concluded
2021 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2017 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027429

Research Plan
Registered date File name
2017/03/01 研究実施計画書(20160428事務局確認).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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