UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001184 |
|---|---|
| Receipt number | 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 11:05:12 |
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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–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
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
Sponsor or person
Institute
Department of Thoracic Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001041
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