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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007167
Receipt No. R000008446
Scientific Title Phase I/II clinical trial of immunoRFA with OK-432 for patients with lung cancer
Date of disclosure of the study information 2012/02/01
Last modified on 2019/09/01

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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/ctr_e/ctr_view.cgi?recptno=R000008446

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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