UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011474 |
|---|---|
| Receipt number | R000012621 |
| Scientific Title | Activated dendritic cell-based tumor-specific immunotherapy against high grade glioma-Phase II trial |
| Date of disclosure of the study information | 2013/08/14 |
| Last modified on | 2023/08/21 09:34:49 |
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Basic information
Public title
Activated dendritic cell-based tumor-specific immunotherapy against high grade glioma-Phase II trial
Acronym
Immunotherapy against high-grade glioma
Scientific Title
Activated dendritic cell-based tumor-specific immunotherapy against high grade glioma-Phase II trial
Scientific Title:Acronym
Immunotherapy against high-grade glioma
Region
| Japan |
Condition
Condition
High-grade glioma
Classification by specialty
| Hematology and clinical oncology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation for an efficacy of activated dendritic cell-based immunotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Relapse-free survival time
Key secondary outcomes
Overall survival time
Antitumor effect
Immunological effect
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
Collaborative treatmnt of concomitant radio-chemotherapy with activated DC vaccine to high-grade glioma patients
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Histological diagnosis of high-grade glioma (WHO Gr3-4)
2. Concomitant chemo-radiation treatment is going to be given after surgery
3. 20 <=Age< 80
4. Performance status; 0-2
5. Measurable lesions in imaging diagnosis
6. HLA genotyping; HLA-A2 or A24
7. No severe organ dysfunction
8. No severe hematostatic dysfunction
9. Informed consents obtained from patients or family members
10. Survival for more than 6 months expected
11. More than 4 weeks interval after last treatment against cancer
Key exclusion criteria
1. Within 28 days afetr the last treatment against cancer
2. Severe systemic infection, hematostatic dysfunction, and organ disorder
3. Steroid treatment except used for cerebral decompression
4. Hypersensitivity to DC vaccine
5. Severe immunological disorders (autoimmune disease, immunosuppression)
6. Multiple cancers
7. Anaphylaxis to synthetic peptides
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuto Akiyama, M.D. |
Organization
Shizuoka Cancer Center Research Institute
Division name
Immunotherapy Division
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
TEL
055-989-5222
y.akiyama@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuto Akiyama, M.D. |
Organization
Shizuoka Cancer Center Research Institute
Division name
Immunotherapy Division
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
TEL
055-989-5222
Homepage URL
y.akiyama@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Prefecture
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
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
静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 14 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012621
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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