UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II clinical trial of immunoRFA with OK-432 for patients with lung cancer
Acronym	Phase I/II clinical trial of immunoRFA for patients with lung cancer
Scientific Title	Phase I/II clinical trial of immunoRFA with OK-432 for patients with lung cancer
Scientific Title:Acronym	Phase I/II clinical trial of immunoRFA for patients with lung cancer
Region	Japan

Condition
Condition	lung cencer(lung neoplasms)
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to investigate the safety, and to evaluater tumor response after combination therapy(lung RFA+OK-432)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Evaluation of safety of combination therapy (lung RFA + OK-432). In the Phase I study, optimal dose of OK-432 (0.5,1,2 or 5KE)will be determined by using 3+3 dose escalation method within 1 month. In phase II study, the safety will be confirmed in the optimal dose determined by Phase I study in larger number of patients. Safety will be evaluated by CTCAE.
Key secondary outcomes	Evaluation of tumor response of combination therapy (lung RFA + OK-432) in treated tumor and not treated tumor.Evaluation will be performed by CT 1 month after treatment. If positive, measurable lesion is identified in the PET before procedure, PET will be evaluate 1 month after treatment.

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	Maneuver
Interventions/Control_1	Combination therapy of OK-432 will be administered locally to the tumor site after lung RFA. After the procedure, the tumor size of ablated and not-ablated tumor will be measured and evaluated.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects must satisfy the following conditions 1) Patient must not be a candidate for surgical procedure and must be a candidate for the lung RFA 2) Patients must have adequate lung function (PaO2 more than 7mmHg(in room air)) 3) Patients must not have interstitial pneumonia (by imaging and serum KL-6 should be less than 500U/ml) 4) Patients must be more than 20 years old and less than 85 years old 5) Patient's body weight must be less than 100kg 6) Patients must be coherent 7) Patients must be at a score level 0 or 1 of performance status(PS) (ECOG) 8) Patients must be expected to survive more than 2 months 9) Written informed consent must be obtained from patients 10) Patients must not have bleeding tendency 11) Patients have lung tumor which is more than 5 mm on CAT scan and can be ablated by RFA 12) Patients must satisfy the followings: WBC is more than 3,000/mm3 Platelet is more than 50,000/mm3 Serum Creatinine is less than 3.0mg/dl
Key exclusion criteria	The following patients must be excluded: 1)Patients with bleeding tendency 2)Patients who cannot take a CAT scan 3)Patients with the past history of severe allergic reactions for OK-432 4)Patients with the past history of severe allergic reactions for Penicillin 5)Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Yamamoto
Organization	Osaka City University
Division name	Department of Radiology
Zip code	5458585
Address	1-4-3 Asahimachi, Abenoku, Osaka, Osaka, Japan 545-8585
TEL	06-6645-3831
Email	loveakirayamamoto@gmail.com

Public contact
Name of contact person	1st name Akira Middle name Last name Yamamoto
Organization	Osaka City University
Division name	Department of Radiology
Zip code	5458585
Address	1-4-3 Asahimachi, Abenoku, Osaka, Osaka, Japan 545-8585
TEL	06-6645-3831
Homepage URL
Email	loveakirayamamoto@gmail.com

Sponsor
Institute	Osaka City University, Department of Diagnostic and Interventional Radiology, Japan
Institute
Department

Funding Source
Organization	Osaka City University, Department of Diagnostic and Interventional Radiology, Japan
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Osaka City University Hospital Certified Review Board
Address	601 1-2-7 Asahi-machi Abeno-ku Osaka, Osaka
Tel	06-6645-3456
Email	ethics@med.osaka-cu.ac.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	大阪市立大学附属病院(大阪府)

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 01 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	Terminated
Date of protocol fixation	2011 Year 11 Month 04 Day
Date of IRB	2016 Year 03 Month 01 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Date of IRB presents date of 2nd IRB permission.

Management information
Registered date	2012 Year 01 Month 30 Day
Last modified on	2019 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008446