UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Phase II Study of Combination Cell-based Immunotherapy in Patients with Treatment-refractory Lung Cancer
Title of the study (Brief title)	The Phase II Study of Combination Cell-based Immunotherapy in Patients with Treatment-refractory Lung Cancer
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate immunological effects of combined cell-based immunotherapy in patients with treatments-refractory lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Immunological monitoring
Key secondary outcomes	Anti-tumor effect Disease-free survival Overall survival Safety

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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	Vaccine
Interventions/Control_1	Dendritic cell-based vaccine (day 1)+ LAK immunotherapy (day 1) Q2weeks, 6 cycles
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histologically determined lung cancer 2. Histologically determined highly expression of MUC1 in cancer cells 3. Refractory for standard anti-cancer treatments 4. Aged 20-85 years old 5. ECOG performance status 0-2 6. No prior anti-cancer treatments within 4 weeks 7. Adequate organs function 8. Written informed consent
Key exclusion criteria	1) Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, hemorrhagic tendency ) 2) Active infections 3) Active simultaneous cancer 4)Massive pleural or pericardial effusion 5) Concurrent treatment with steroids or immunosuppressing agent 6) Other conditions not suitable for this study
Target sample size	30

Research contact person
Name of lead principal investigator	Koji Teramoto
Organization	Shiga University of Medical Science
Division name	Department of Clinical Oncology
Address	Seta-Tsukinowa, Otsu, Shiga, Japan
TEL
Email

Public contact
Name of contact person	Koji Teramoto
Organization	Shiga University of Medical Science
Division name	Department of Clinical Oncology
Address	Seta-Tsukinowa, Otsu, Shiga, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 01 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 21 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 10 Day
Last modified on	2016 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000011422