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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011474
Receipt No. 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 2018/02/15

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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
Email 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
Email y.akiyama@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 22 Day
Date of IRB
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
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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