UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023806 |
|---|---|
| Receipt number | 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 | 2024/03/05 09:09:33 |
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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
YES
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 | Yasuharu |
| Middle name | |
| Last name | Akasaki |
Organization
Jikei University School of Medicine
Division name
Department of Neurosurgery
Zip code
105-8461
Address
3-25-8 Nishishinbashi Minato-ku, Tokyo
TEL
03-3433-1111
akasaki@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Akasaki |
Organization
Jikei University School of Medicine
Division name
Department of Neurosurgery
Zip code
105-8461
Address
3-25-8 Nishishinbashi Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
akasaki@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
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
Committee for regenerative medicine, Jikei University School of Medicine
Address
3-25-8 Nishisinbashi Minato-ku, Tokyo
Tel
+81334331111
saiseiiryo@jikei.ac.jp
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
