UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007321 |
|---|---|
| Receipt number | R000008631 |
| Scientific Title | A clinical study of alpha-Galactosylceramide pulsed dendritic cells (Chiba-NKT) in patients with advanced or recurrent non-small cell lung cancer. A phase II study. |
| Date of disclosure of the study information | 2012/02/17 |
| Last modified on | 2020/02/25 16:44:09 |
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Basic information
Public title
A clinical study of alpha-Galactosylceramide pulsed dendritic cells (Chiba-NKT) in patients with advanced or recurrent non-small cell lung cancer. A phase II study.
Acronym
alpha-Galactosylceramide pulsed DCs in patients with NSCLC
Scientific Title
A clinical study of alpha-Galactosylceramide pulsed dendritic cells (Chiba-NKT) in patients with advanced or recurrent non-small cell lung cancer. A phase II study.
Scientific Title:Acronym
alpha-Galactosylceramide pulsed DCs in patients with NSCLC
Region
| Japan |
Condition
Condition
unresectable or recurrent non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy, safety and immunological response mediated by intravenous administration of alpha-Galactosylceramide pulsed Dendritic cells (Chiba-NKT) in patients with advanced or recurrent non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
progression free survival, response rate, disease control rate, safety, NKT cell-specific immune 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 |
Interventions/Control_1
Alpha-Galactosylceramide-pulsed dendritic cells are injected twice in one course.Two courses are scheduled.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients matching the following criteria. A histologically diagnosed advanced or recurrent non-small cell lung cancer and have already received firstline chemotherapy. At least one measurable lesion according to the RECIST ver1.1 criteria. Performance status (ECOG) 0-1. At least a four week interval between prior treatment. No hepatic, renal or bone marrow insufficiency. Survival expectation of more than three months. NKT cells are detected at least 10 cells/ml in peripheral blood. Written consent by the patient.
Key exclusion criteria
Patients matching any of the following criteria.
Patients who have serious complications such as severe infection or malnutrition. Patients with pleural effusion or ascites, pericardial effusion, uncontrolled brain metastasis, simultaneous double cancer, receiving corticosteroid treatment, autoimmune disease, a past history of hepatitis, positive for HBs antigen, anti-HCV antibody, anti-HIV antibody, anti-HTLV-1 antibody, severe cardiac disease(NYHA classIII or more) or respiratory disease(Hugh-Jones classIII or more). Patients with a past history of hypersensitivity to albumin. Pregnant or breast feeding women. Patients whose medical condition cannot allow leukoapheresis. Patients who are considered ineligible to participate in the clinical trial.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Motohashi |
Organization
Graduate school of Medicine, Chiba University
Division name
Department of Medical Immunology
Zip code
2608670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
motohashi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Motohashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Medical Immunology
Zip code
2608670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
Homepage URL
motohashi@faculty.chiba-u.jp
Sponsor or person
Institute
Department of General Thoracic Surgery, Graduate school of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-222-7171
motohashi@faculty.chiba-u.jp
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
| 2012 | Year | 02 | Month | 17 | 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
| 2012 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 17 | Day |
Last modified on
| 2020 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008631
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