UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001016 |
|---|---|
| Receipt number | R000001228 |
| Scientific Title | Trial for in vitro screening of cytotoxic T lymphocyte induction with use of allogeneic dendritic cells for patients with pleural or peritoneal carcinomatosis |
| Date of disclosure of the study information | 2008/02/05 |
| Last modified on | 2009/11/25 13:11:40 |
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Basic information
Public title
Trial for in vitro screening of cytotoxic T lymphocyte induction with use of allogeneic dendritic cells for patients with pleural or peritoneal carcinomatosis
Acronym
In vitro screening of CTL induction by allogeneic dendritic cells for pleural or peritoneal carcinomatosis
Scientific Title
Trial for in vitro screening of cytotoxic T lymphocyte induction with use of allogeneic dendritic cells for patients with pleural or peritoneal carcinomatosis
Scientific Title:Acronym
In vitro screening of CTL induction by allogeneic dendritic cells for pleural or peritoneal carcinomatosis
Region
| Japan |
Condition
Condition
Peritoneal or pleural carcinomatosis (carcinomas of the stomach, colorectum, biliary duct, pancreas, uterus, ovary, kidney, lung or malignant melanoma etc.) and malignant mesothelioma
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Nephrology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Obstetrics and Gynecology | Dermatology |
| Urology | Blood transfusion |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Cancer-specific cytotoxic T lymphocyte (CTL) induction rate by dendritic cells is evaluated for the patients with peritoneal or pleural carcinomatosis in vitro.
Basic objectives2
Others
Basic objectives -Others
Cytotoxic activity or cytokine production is evaluated for the CTL induced by auto dendritic cells compared with that induced by allogeneic DCs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Induction rate of cancer-specific cytotoxic T lymphocyte (CTL) in vitro
Key secondary outcomes
Cytotoxic potency or cytokine production of the cancer-specific CTL
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been already clinically or histologically diagnosed as primary or recurrent stomach, colorectal, biliary, pancreas, uterine, ovarian, renal, lung cancers or malignant melanoma etc, or malignant mesothelioma with pleural or peritoneal carcinomatosis.
2) Malignant cells (class V) are detected in ascites or pleural effusion by cytological test. 3) New chemotherapy or radiotherapy should not be started during the present study.
4) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
6) Body weight is more than 45kg for male and 40kg for female.
7) Expected survival over 6 months.
8) Written informed consent must be obtained from patients and legally acceptable representatives.
Key exclusion criteria
1) Active double cancer.
2) Exclude the patients who have serious illness or suspect to have serious illness.
3) Myocardial infarction or unstable angina, occurred within 6 months.
4) Psychosis.
5) Women during pregnancy or breast-feeding.
6) Previous history of severe drug-induced allergy.
7) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kamigaki |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastrointestinal Surgery
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL
078-382-5925
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kamigaki |
Organization
Kobe University Hospital
Division name
Division of Gastrointestinal Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL
078-382-5925
Homepage URL
http://www.med.kobe-u.ac.jp/surg1/index.html
menekidc@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastrointestinal Surgery, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Superiority of allogeneic dendritic cells for induction of the CTL to auto dendritic cells.
Management information
Registered date
| 2008 | Year | 02 | Month | 05 | Day |
Last modified on
| 2009 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001228
