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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009424
Receipt No. 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

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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
Obsterics 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
Email 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
Email takaishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Center for Advanced Medical Innovation, Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011070

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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