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 |
Clinical trial of cellular immunotherapy for malignant tumor
(cancer immunotherapy with dendritic cell-based vaccines)
Cancer immunotherapy with dendritic cell-based vaccines
Clinical trial of cellular immunotherapy for malignant tumor
(cancer immunotherapy with dendritic cell-based vaccines)
Cancer immunotherapy with dendritic cell-based vaccines
Japan |
all classes of malignant tumors, after treatment with (or not applicable for) standard therapies for cancers
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 |
Malignancy
YES
Safety and efficacy of dendritic cell-based vaccine immunotherapy for malignant tumor
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Overall survival period (OS) for each class of malignant tumors
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Other |
Dendritic cells are subcutanously administered almost every two weeks. Minimum dose of each injection will be more than 5 million cells
20 | years-old | <= |
Not applicable |
Male and Female
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
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
40
1st name | |
Middle name | |
Last name | Koichi Akashi |
Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University and Project Division, Center for Advanced Medical Innovation, Kyushu University
Professor, Dupty Director
3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan
092-642-5228
akashi@med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Tadafumi Iino ( or Shigeo Takaishi ) |
Center for Advanced Medical Innovation, Kyushu University
Division of Advanced Cell Therapy
3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan
092-642-4258
http://camiku.kyushu-u.ac.jp/about/clinic/immune-cell-therapy
takaishi@kuhp.kyoto-u.ac.jp
Center for Advanced Medical Innovation, Kyushu University
Center for Advanced Medical Innovation, Kyushu University
Self funding
YES
12-E06
Clinical Research Network Fukuoka
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)
2012 | Year | 11 | Month | 28 | Day |
Unpublished
under analysis
Completed
2012 | Year | 11 | Month | 12 | Day |
2012 | Year | 11 | Month | 12 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
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.
2012 | Year | 11 | Month | 28 | Day |
2017 | Year | 06 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011070