UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007167 |
|---|---|
| Receipt number | 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 01:12:43 |
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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
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
loveakirayamamoto@gmail.com
Sponsor or person
Institute
Osaka City University, Department of Diagnostic and Interventional Radiology, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008446
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