UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma
Title of the study (Brief title)	Phase 1 Trial of Zoredronic Acid in Malignant Pleural Mesothelioma
Region	Japan

Condition
Condition	Malignant Pleural Mesothelioma
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	o establish the safety of intra-thoracic administration of Zoredronic Acid and to guide decision making for the effective dose
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Evaluation of the incidence of the adverse effect and dose limiting dose(DLT)
Key secondary outcomes	Anti-tumor effect (Response to the 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	Medicine
Interventions/Control_1	Initial dose of 0.4mg of Zoredronic acid will be administered by injection into thoracic cavity. Thereafter, patients will be observed for at least two weeks to evaluate the adverse effects. Transition to the next cohort will be decided following the evaluation of the development of DLT. The dose will be gradually increased every three subjects from 0.4mg to 1mg, 4mg, 8mg, 12mg and 16mg respectively.Repeat injections for the same patient at the same dose are acceptable.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with histologically or cytologically documented malignant pleural mesothelioma Unresectable case(including recurrent case of post-operation) Patients refractory to chemotherapy, or those relapsed after therapies. Patients who reject chemotherapy will be also included. ECOG Performance status 0 to 2 Life expectancy must be longer than 3 month from the entry. Patients who are free of marked failure of major organ function, more over the following criteria must be satisfied in laboratory tests. WBC >=3000/mm3, neutrophil>=1500 /mm3, Hgb>= 8.0 g/dl, Plt >=100.000 /mm3, AST/ALT<= 100 IU/L, T-Bil<=1.5 mg/dl, Cre<=1.5 mg/dl Ccr >=60 ml/min , PaO2>= 60 mmHg or>=90% by pulse oxymetry Informed consent must be obtained
Key exclusion criteria	Patient with active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs) Patient with symptomatic brain metastasis requiring any treatments Patient underwent thoracic irradiation therapy or pleurodesis (within a month). Patient with interstitial pneumonia, confirmed by clinical examination or by chest CT scan Patients with history of myocardial infarction (MI) in recent 6 month, or those with any risk of MI recurrence. Patient with other severe medical complications. Patient with history of drug-related allergy to zoredronic acid or other bisphosphonate or those with AEs over Grade 3 in CTCAE. Patient with stomatognathic disease (pulpitis, gingivitis,etc) requiring invasive (surgical) treatment. Patient who received chemotherapy for mesothelioma, or those participated other clinical trial for unapproved drug with in a month. Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms Pregnant or lactating woman. Ineligible to the trial based on decision of an investigator, such as poor compliance to follow up in the clinical course.
Target sample size	18

Research contact person
Name of lead principal investigator	Yuji Tada
Organization	Chiba University Hospital
Division name	Department of Respirology
Address	260-5670 1-8-1 Inohana Chuo-ku Chiba, Chiba prefecture, Japan
TEL	81432227171
Email	ytada@faculty.chiba-u.jp

Public contact
Name of contact person	Yuji Tada
Organization	Chiba University Hospital
Division name	Department of Respirology
Address	260-5670 1-8-1 Inohana Chuo-ku Chiba, Chiba prefecture, Japan
TEL	81432227171
Homepage URL	http://www.m.chiba-u.ac.jp/class/respir/index.html
Email	ytada25@yahoo.co.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Chiba Cancer Center Toho University Omori Medical Center Tokyo Women's Medical University Yachiyo Medical Center
Name of secondary funｄer(s)	none

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	千葉大学医学部附属病院（千葉県）　Chiba University Hospital

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 26 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2018 Year 12 Month 24 Day
Date of closure to data entry	2018 Year 12 Month 24 Day
Date trial data considered complete	2018 Year 12 Month 24 Day
Date analysis concluded	2018 Year 12 Month 24 Day

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

Management information
Registered date	2012 Year 06 Month 04 Day
Last modified on	2019 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008987