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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005208
Receipt No. R000006189
Scientific Title Clinical study of administration of alpha-GalactosylCeramide-pulsed DCs by bronchoscopy in patients with either advanced or recurrent non-small cell lung cancer (NSCLC)
Date of disclosure of the study information 2011/03/08
Last modified on 2012/03/20

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Basic information
Public title Clinical study of administration of alpha-GalactosylCeramide-pulsed DCs by bronchoscopy in patients with either advanced or recurrent non-small cell lung cancer (NSCLC)
Acronym Clinical study of administration of alpha-GalactosylCeramide-pulsed DCs by the bronchoscopy
Scientific Title Clinical study of administration of alpha-GalactosylCeramide-pulsed DCs by bronchoscopy in patients with either advanced or recurrent non-small cell lung cancer (NSCLC)
Scientific Title:Acronym Clinical study of administration of alpha-GalactosylCeramide-pulsed DCs by the bronchoscopy
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 alpha-GalactosylCeramide-pulsed dendritic cell by bronchoscopy in patients with either advanced or recurrent non-small cell lung cancer (NSCLC) is examined. The safety, immunological responses and clinical effects are investigated.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Safety
Key secondary outcomes The clinical effects and immunological responses

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 Maneuver
Interventions/Control_1 Intratumoral or intranodal administrations of alpha-GalactocylCeramide pulsed DCs by bronchoscopy are performed on day 7 and 14 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 with either advanced or recurrent non-small cell lung cancer, who have received chemotherapy or radiotherapy. Patients who have measurable disease in the lung and have lymph node over 5mm diameter.
Patients whose life-expectancy is more than 6 months; Performance status 0-2; Normal bone marrow, liver and renal functions; NKT cells are detected at least 10 cells in 1 ml of peripheral blood.
Key exclusion criteria Patients who have: uncontrolled diabetes mellitus, pulmonary fibrosis, and/or infection; synchronous multiple cancer; a history of hepatitis; a positive response for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV), or human T-lymphotrophic virus antibodies; serious cardiac diseases; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to practice in this study by principle investigator
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Yoshino
Organization Graduate School of Medicine, Chiba University
Division name Department of General Thoracic Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-222-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Motohashi
Organization raduate School of Medicine, Chiba University
Division name Department of immunology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email

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

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
2011 Year 03 Month 08 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
2009 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 07 Day
Last modified on
2012 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006189

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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