UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005776 |
|---|---|
| Receipt number | R000006825 |
| Scientific Title | Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer |
| Date of disclosure of the study information | 2011/06/14 |
| Last modified on | 2014/05/23 10:49:22 |
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Basic information
Public title
Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Acronym
Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Scientific Title
Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Scientific Title:Acronym
Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy on combination therapy of autologous tumor lysate-pulsed dendritic cell vaccination and standard adjuvant chemotherapy after resection of lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Immunological responses
Recurrence-free survival
Overall survival
Survival rate (3 and 5 years)
Response of tumor-related markers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine | Maneuver |
Interventions/Control_1
1)Tumor lysate-pulsed dendritic cells (biweekly, 6 times)
2)Standard adjuvant chemotherapy
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
Lung cancer patients who received resection of primary lesion:
(1)Performance Status is 0-1
(2)No serious abnormality in bone marrow, liver, and renal functions
(3)Whose life-expectancy is more than 3 months
Key exclusion criteria
Patients who have:
(1)Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them
(2)Serious drug allergy
(3)Serious cardiac disease
(4)Active autoimmune disease
(5)Other cancers
(6)Active infections
(7)Positive for HIV or HTLV-1
(8)Other serious complications
(9)Pregnant or lactating
(10)Continuous systemic administration of steroids
(11)Any reason why, in the opinion of the investigator, the patient should not participate.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosei Yasumoto |
Organization
Seta Clinic Fukuoka
Division name
Medical oncology
Zip code
Address
Random square 5F, 6-18 Tenya-machi, Hakata-ku, Fukuoka, 812-0025, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ibe |
Organization
Seta Clinic
Division name
Clinical research center
Zip code
Address
Kokoro to karada no genki plaza 8F, 3-6-5 Iidabashi, Chiyoda-ku, Tokyo, 102-0072, Japan
TEL
03-5215-0086
Homepage URL
scrc@j-immunother.com
Sponsor or person
Institute
Seta Clinic Fukuoka
Institute
Department
Personal name
Funding Source
Organization
Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
瀬田クリニック福岡（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
9th Japan Research Association for Immunotherapeutics(2012.2.18)
13th Central European Lung Cancer Conference (2012.6.24-27)
16th Japanese Association of Cancer Immunology(2012.7.26-28)
15th World Conference on Lung Cancer
(2013.10.27-30)
54th The Japan Lung Cancer Society
(2013.11.21-22)
Management information
Registered date
| 2011 | Year | 06 | Month | 14 | Day |
Last modified on
| 2014 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006825
