UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000948 |
|---|---|
| Receipt number | R000001138 |
| Scientific Title | Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with advanced and recurrent lung cancer |
| Date of disclosure of the study information | 2007/12/14 |
| Last modified on | 2008/12/17 22:16:21 |
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Basic information
Public title
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with advanced and recurrent lung cancer
Acronym
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with advanced and recurrent lung cancer
Scientific Title
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with advanced and recurrent lung cancer
Scientific Title:Acronym
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with advanced and recurrent lung cancer
Region
| Japan |
Condition
Condition
primary lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The feasibility of alpha-GalactosylCeramide-pulsed dendritic cell and natural killer T (NKT) cell immunotherapy in patients with advanced or recurrent lung cancer are examined. The immunological responses and anti-tumor effects are also investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
Key secondary outcomes
Immunological response and Clinical response
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 | Maneuver |
Interventions/Control_1
In patients with advanced or recurrent lung cancer, intra-venous injections of alpha-GalactosylCeramide pulsed DCs are performed at 1, 2, 7 and 8 weeks after the entry.
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
patients had received no chemotherapy or radiotherapy
for at least 6 weeks before enrollment. patients with a histologic or cytological diagnosis of non-small cell lung cancer, life-expectancy is more than 6 months, Performance status 0-1, Normal bone marrow, liver and renal functions, NKT cells are detected at least 10 cells in 1 mL of peripheral blood
Key exclusion criteria
the presence of active infection; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; evedence for other malignant diseases; serious cardiac disease, recieived concurrent corticosteroid therapy; pregnancy or lactation; been judged to be inappropriate to participate in this study by principle investigator or co-investigator
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Fujisawa |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Thoracic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2966
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Motohashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Thoracic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2966
Homepage URL
Sponsor or person
Institute
Department of Thoracic Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
National Institute of Biomedical Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2007 | Year | 12 | Month | 14 | 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
| 2004 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 14 | Day |
Last modified on
| 2008 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001138
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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