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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000948
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Thoracic Surgery, Graduate School of Medicine, Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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