Unique ID issued by UMIN | UMIN000007527 |
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Receipt number | R000008874 |
Scientific Title | Phase 1 clinical study of highly purified natural killer (NK) cell infusion for patients with refractory digestive/gastrointestinal cancer to standard therapy |
Date of disclosure of the study information | 2012/04/01 |
Last modified on | 2015/10/11 13:17:12 |
Phase 1 clinical study of highly purified natural killer (NK) cell infusion for patients with refractory digestive/gastrointestinal cancer to standard therapy
Phase 1 clinical study of NK cell infusion for patinets with digestive/gastrointestinal cancer
Phase 1 clinical study of highly purified natural killer (NK) cell infusion for patients with refractory digestive/gastrointestinal cancer to standard therapy
Phase 1 clinical study of NK cell infusion for patinets with digestive/gastrointestinal cancer
Japan |
refractory digestive/gastrointestinal cancer
Gastroenterology | Hepato-biliary-pancreatic medicine |
Malignancy
NO
To assess the safety of NK cell infusion therapy
Safety,Efficacy
Exploratory
Pragmatic
Phase I
safety
anti-tumor effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Intravenous transfer of autologous NK cells.
Dose-escalation study with three groups
1)5x10*8 cells 3 patients
2)1x10*9 cells 3 patients
3)2x10*9 cells 3 patients
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Histologically confirmed digestive/gastrointestinal cancer.
2) Patients informed diagnosis of their disease
3) Patients must have refractory disease to standard treatment, and in the situation where curative treatment opions are not available.
4) Without planning to recieve chemotherapy, radiation therapy or immunotherapy. Oral 5-FU drugs are permitted.
5) Aged from 20 to 80 years
6) Grade 0 to 2 in performance status(ECOG).
7) Sufficient functions of major organ.
8) Expected to be alive at least three months after informed consent.
9) Lasting at least four weeks since the previous chemotherapy or radiotherapy, or two weeks since the previous administration of 5-FU. But oral 5-FU drugs are permitted.
10) Having written informed consent.
1) Presence of uncontrolled infection
2) Hypersensitivity or autoimmune disease requiring treatments
3) Presence of severe comlications(malignant hypertension, congestive heart failure, severe coronary disease, history of myocardial infarction less than six months prior, pulmonary fibrosis or active interstitial pneumonitis)
4) Inappropriate patients for this study due to severe complications.
5) Patient who cannot undergo enhanced CT scan or MRI due to some reason such as allergy for contrast media or renal dysfunction.
6) Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable.
7) Medical history of severe hypersensitivity.
8) Severe mental impairment
9) Pregnant or lactating women
10) Patient with HBV, HCV, HIV, HTLV-1 or syphilis infection
11) Inappropriate patients for study judged by the physicians.
9
1st name | |
Middle name | |
Last name | Satoshi Kokura |
Kyoto Prefectural University of Medicine
Cancer ImmunoCell Regulation
Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan
075-251-5519
s-kokura@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Ishikawa Takeshi |
Kyoto Prefectural University of Medicine
Cancer ImmunoCell Regulation
Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan
075-251-5519
iskw-t@koto.kpu-m.ac.jp
Cancer ImmunoCell Regulation, Kyoto Prefectural Univercity of Medicine
Kyoto Prefectural Univercity of Medicine
Self funding
Japan
TAKARA BIO, INC
NO
2012 | Year | 04 | Month | 01 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/26303618
Completed
2012 | Year | 03 | Month | 21 | Day |
2012 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 19 | Day |
2015 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008874
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