UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000775 |
|---|---|
| Receipt number | R000000934 |
| Scientific Title | Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer |
| Date of disclosure of the study information | 2007/08/01 |
| Last modified on | 2007/07/25 23:06:30 |
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Basic information
Public title
Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer
Acronym
Dendritic cell therapy for patients with advanced cancer
Scientific Title
Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer
Scientific Title:Acronym
Dendritic cell therapy for patients with advanced cancer
Region
| Japan |
Condition
Condition
advanced and recurrent cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and effectiveness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
safety
Key secondary outcomes
effectiveness
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
| Vaccine |
Interventions/Control_1
cell therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
advanced and recurrent cancer
PS:0-2
No infection
1. 3500<WBC<12,000/cmm
2. platelet>100,000/cmm
3. No severe liver dysfuntion
4. T-Bil<2.0mg/dl
5. UN<25mg/dl
6. Creatinin<1.5mg/dl
7. 24hr Ccr>50ml/min
after completion of informed consent
8. normal ECG
Key exclusion criteria
Pregnancy
Severe Psychiatric disoreder
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ohto Hitoshi |
Organization
Fukushima Medical University
Division name
Dept. of Blood transfusion and Transplantation
Zip code
Address
Hikarigaoka 1, Fukushima
TEL
024-547-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ohto Hitoshi |
Organization
Fukushima Medical University
Division name
Dept. of Blood transfusion and Transplantation
Zip code
Address
024-547-1111
TEL
Homepage URL
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical 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
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
| 2007 | Year | 08 | Month | 01 | 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
Date of protocol fixation
| 2007 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 25 | Day |
Last modified on
| 2007 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000934
