UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006276 |
|---|---|
| Receipt number | R000007428 |
| Scientific Title | The clinical study of the activated self-lymphocytes introduction therapy using a self-tumor (tissue) and a dendritic cells for a relapse and a advanced cancer. |
| Date of disclosure of the study information | 2011/09/05 |
| Last modified on | 2015/01/05 12:13:36 |
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Basic information
Public title
The clinical study of the activated self-lymphocytes introduction therapy using a self-tumor (tissue) and a dendritic cells for a relapse and a advanced cancer.
Acronym
The clinical study of the activated self-lymphocytes introduction therapy using a self-tumor (tissue) and a dendritic cells for a relapse and a advanced cancer.
Scientific Title
The clinical study of the activated self-lymphocytes introduction therapy using a self-tumor (tissue) and a dendritic cells for a relapse and a advanced cancer.
Scientific Title:Acronym
The clinical study of the activated self-lymphocytes introduction therapy using a self-tumor (tissue) and a dendritic cells for a relapse and a advanced cancer.
Region
| Japan |
Condition
Condition
Relapse and advanced cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establishment of the procedure and verification of tolerability, safety and efficacy for "the activated self-lymphocytes introduction therapy using a self-tumor (tissue) and dendritic cells1" for a relapse and an advanced cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establishment of the procedure, verification of tolerability and safety of "the activated self-lymphocytes introduction therapy using a self-tumor (tissue) and dendritic cells.
Key secondary outcomes
QOL, A cytoreductive effect and a prognosis prolongation effect.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Activated self-lymphocytes
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
1) The patients that the diagnosis of the cancer was obtained by histological diagnosis or cytodiagnosis.
2)An outpatients over 20 years old.
3) Performance States (P.S.) is 0 to 3.
4) The good prognosis will be expected 3 months or more until administration starting point.
5) In principle, keep major organ function is kept as follows;
Number of White Blood Cell>4,000/mm3, <12,000/mm3.
Number of neutrophil>2,000/mm3.
Platelet count>100,000/mm3.
Number of hemoglobin>10.0g/dL.
Serum GOP and GPT< upper limits of institution x 2.
Total serum bilirubin<1.5mg/dL.
Serum creatinine<1.5mg//dL.
But in the case of not meet a condition, reason came from existing diseasey(Cancer). Lead principal investigator can add those patients to this study by his judgment.
6) The patient that agreement was obtained in a document than the person himself in response to a name of disease condition notice.
7) Women; Pregnant possibility is denied by surgery, radiation or menopause, or possibility of pregnant can be reduced by the use of the approved antifertility method from the administration starting point to after 3 month of study finished.
Key exclusion criteria
1) The patients with autoimmune disease
2) The patients with complications having poor control. (An infection, diabetes, hypertension, ischemic heart disease, cerebral infraction, etc.).
3) The patients egnancy nursing mother and the pregnant likelihood(possibility).
4) The patients history of the drug allergy.
5) Other, the patients is judged inadequate by research contact person.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Shiroma |
Organization
Tomishiro Central Hospital
Division name
Department of Surgery
Zip code
Address
25 Ueta, Tomigusuku-shi, Okinawa, Japan
TEL
098-850-3811
h.shiroma@yuuai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Ochiai |
Organization
Tomishiro Central Hospital
Division name
Office of Clinical Trial
Zip code
Address
Kanehiro Sangyo 2nd Bldg #202, 293-1 Gibo, Tomigusuku-shi, Okinawa, 901-0244, Japan
TEL
098-851-8131
Homepage URL
ochiai.tomishirocentral.hp@gmail.com
Sponsor or person
Institute
Tomishiro Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Okinawa Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawasaki Medical School, clinical oncology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
社会医療法人友愛会豊見城中央病院（沖縄県）／Tomishiro Central Hospital(Okinawa)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 05 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 02 | Day |
Last modified on
| 2015 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007428
| 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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