UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009424 |
|---|---|
| Receipt number | R000011070 |
| Scientific Title | Clinical trial of cellular immunotherapy for malignant tumor (cancer immunotherapy with dendritic cell-based vaccines) |
| Date of disclosure of the study information | 2012/11/28 |
| Last modified on | 2017/06/02 12:52:10 |
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Basic information
Public title
Clinical trial of cellular immunotherapy for malignant tumor
(cancer immunotherapy with dendritic cell-based vaccines)
Acronym
Cancer immunotherapy with dendritic cell-based vaccines
Scientific Title
Clinical trial of cellular immunotherapy for malignant tumor
(cancer immunotherapy with dendritic cell-based vaccines)
Scientific Title:Acronym
Cancer immunotherapy with dendritic cell-based vaccines
Region
| Japan |
Condition
Condition
all classes of malignant tumors, after treatment with (or not applicable for) standard therapies for cancers
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Nephrology | Surgery in general | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Ophthalmology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Oral surgery | Neurosurgery |
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Safety and efficacy of dendritic cell-based vaccine immunotherapy for malignant tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival period (OS) for each class of malignant tumors
Key secondary outcomes
Progression-free survival period (PFS), Disease-free survival period (DFS), response rate, efficience rate, disease control rate, side effetcs, etc for each class of malignant tumors
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
| Other |
Interventions/Control_1
Dendritic cells are subcutanously administered almost every two weeks. Minimum dose of each injection will be more than 5 million cells
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients to be included would satisfy all of the following conditions:
(1) pathologically diagonized as and informed with malignant tumors, or if patients are diagonized as malignant tumors (such as liver , bile duct and pancreatic cancers) not pathologically but clinically i.e. with diagnostic imaging and laboratory finding, then treated with standard therapy
(2) after treatment with (or not applicable for) standard therapies
(3)If tumor tissues are available, immunohistochemical staining of them for MHC class I is positive
(4) age at the entry into this study is not less than 20
(5) outward patient
(6) prognosis at the entry into this study is not less than 3 months and affordable with completion of 1 course immunotherapy (6 times injections)
(7) fully informed of the treatment of this study with written consent
Key exclusion criteria
Patients to be excluded would satisfy any of the following conditions:
(1) T cell- or NK cell-originated leukemia/lymphoma
(2) serum positive for HTLV-1 and/or HIV antibody
(3) organ- or allogeneic bone marrow-transplant recipients
(4) Patients to be or wishing for pregnancy, or breast-feeding
(5) Inward patients
(6) Patientss who are regarded as inadequate for study enrollment by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Akashi |
Organization
Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University and Project Division, Center for Advanced Medical Innovation, Kyushu University
Division name
Professor, Dupty Director
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan
TEL
092-642-5228
akashi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadafumi Iino ( or Shigeo Takaishi ) |
Organization
Center for Advanced Medical Innovation, Kyushu University
Division name
Division of Advanced Cell Therapy
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan
TEL
092-642-4258
Homepage URL
http://camiku.kyushu-u.ac.jp/about/clinic/immune-cell-therapy
takaishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Center for Advanced Medical Innovation, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Center for Advanced Medical Innovation, Kyushu University
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
YES
Study ID_1
12-E06
Org. issuing International ID_1
Clinical Research Network Fukuoka
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学先端医療イノベーションセンター（福岡県）
(Center for Advanced Medical Innovation, Kyushu University)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 28 | 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
under analysis
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 | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
The law for ensuring safety of regenerative medicine has been effective since November 25th 2014. Then, after around one year, since November 27th 2015, this trial has been terminated and transitted into the new trial in combination with other cell-based cancer immunotherapies.
Management information
Registered date
| 2012 | Year | 11 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011070
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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