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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001184
Receipt No. R000001041
Scientific Title Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer.
Date of disclosure of the study information 2008/06/12
Last modified on 2008/12/11

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Basic information
Public title Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer.
Acronym Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer.
Scientific Title Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer.
Scientific Title:Acronym Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer.
Region
Japan

Condition
Condition primary lung cancer (operable case)
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 operable 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 Immunological response
Key secondary outcomes Safety, Clinical response

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 In patients, intra-venous injection of alpha-GalactosylCeramide pulsed DCs is performed at 1week before operation. Within 3 months after operation he is re-entried, and alpha-GalactosylCeramide pulsed DCs are performed at 1, 2, 7 and 8 weeks after the re-entry.
Interventions/Control_2 In control group, intra-venous injection of alpha-GalactosylCeramide pulsed DCs is not performed before and after operation.
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 1. Patients between 20 and 80 years of age, with a histologic or cytologic diagnosis of non&#8211;small cell lung cancer for which operation is planned.
2. Clinical stage is IIB or IIIA.
3. Performance status of 0, 1, or 2
4. Normal or near normal renal, hepatic, and hematopoietic function
5. NKT cells are detected at least 10 cells in 1 mL of peripheral blood.
Key exclusion criteria 1. Patients who have been treated with surgery or chemotherapy or radiotherapy received for at least 4 weeks before enrollment.
2. Histology is large cell neuroendocrine carcinoma.


3. The exclusion criteria were a positive response to HIV, hepatitis C virus, or human T-cell lymphotrophic virus antibodies; positive for hepatitis B antigen; the presence of active inflammatory disease or active autoimmune disease; a history of hepatitis; pregnancy or lactation; concurrent corticosteroid therapy; and evidence for another active malignant neoplasm. The histologic type, tumor-node-metastasis classification, and the antitumor effect of treatment were classified according to the general rules for clinical and pathologic recording of lung cancer as described by the Japan Lung Cancer Society.
Target sample size 20

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 Thoracic Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
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 043-222-7171
Homepage URL
Email

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

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
2008 Year 06 Month 12 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
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2009 Year 04 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 11 Day
Last modified on
2008 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001041

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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