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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018497
Receipt No. R000021402
Scientific Title Prospective study of I-131 3-iodobenzylguanidine radiotherapy for refractory pheochromocytoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Date of disclosure of the study information 2015/07/31
Last modified on 2020/02/13

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Basic information
Public title Prospective study of I-131 3-iodobenzylguanidine radiotherapy for refractory pheochromocytoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Acronym Prospective study of I-131 3-iodobenzylguanidine radiotherapy for refractory pheochromocytoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Scientific Title Prospective study of I-131 3-iodobenzylguanidine radiotherapy for refractory pheochromocytoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Scientific Title:Acronym Prospective study of I-131 3-iodobenzylguanidine radiotherapy for refractory pheochromocytoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Region
Japan

Condition
Condition Refractory pheochromocytoma (including paraganglioma)
Classification by specialty
Endocrinology and Metabolism Endocrine surgery Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the safety and the efficacy of I-131 3-iodobenzylguanidine (I-131 MIBG) radiotherapy for I-123 MIBG-avid refractory pheochromocytoma, along with the following primary and secondary endpoints. Additionally, this study was performed in accordance with the Japanese Advanced Medical Care B program ahead to sponsor initiated clinical trial, which intend to rationalize application for approval under the Japanese Pharmaceutical and Medical Device Act.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dose limiting toxicity (DLT)
Key secondary outcomes Types and frequency of adverse event/reaction
Response rate under the RECIST criteria
Response rate under scintigraphic evaluation of MIBG
Overall survival (OS)
Progression-free survival (PFS)

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 I-131 3-iodobenzylguanidine (I-131 MIBG) radiotherapy

Administering the radiopharmaceutical in accordance with the following regimen every 24 weeks until satisfying withdrawal or dose-reduction criteria.
Radiopharmaceutical: 131I-MIBG
Dose: 7,400MBq (=200mCi)* i.v. in 1 hour
*Administering maximal dose of permitted amount of radioisotopes in each facility, if permitted amount is lower than 7,400MBq.
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

Not applicable
Gender Male and Female
Key inclusion criteria Satisfying all the following conditions.
1)Confirmed pheochromocytoma, paraganglioma, malignant pheochromocytoma, or malignant paraganglioma.
2)Not applicable any kind of surgical treatment and radical external irradiation.
3)I-123 MIBG-avid tumor.
4)Satisfying each condition:
4)-1 WBC >= 3,000[/mm3], Hb >= 9.0[g/dL] and platelets >= 100,000[/mm3] under G-CSF non-administraion.
4)-2 eGFR >= 30[mL/min/1.73m2]
4)-3 AST < 100[IU/L], ALT < 100[IU/L] and LDH < 400[IU/L]
4)-4 New York Heart Association (NYHA) Functional Classification class I or below.
4)-5 HbA1c < 8.0%
4)-6 Oxygen saturation >= 96[%] at room air.
5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 and Karnofsky Performance Scale (KPS) 80[%] or more.
6)Age 20 or older.
7)Independent feeding, excretion and sleeping.
8)Written consent to participate in this study and treatment.
Key exclusion criteria Satisfying any of the following conditions.
1)Previous or current malignancies of other histologies within the last 5 years.
2)History of tumor deterioration under the condition of I-131 MIBG radiotherapy before this study.
3)History of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or more in non-hematotoxicity, or grade 3 or more in hematotoxicity under the condition of I-131 MIBG radiotherapy before this study.
4)CTCAE grade 2 or more toxicity currently treated under the condition of any kind of anticancer treatments before this study.
5)Diagnosed as Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency virus (HIV) or any other infections currently treated.
6)Episodes of severe symptoms due to uncontrollable increase of catecholamines.
7)Episodes of fatal arrhythmia or asystole.
8)Diagnosed as any of the following diseases or conditions out of control.
8)-1 symptomatic arrhythmia
8)-2 thyroid dysfunction (hyperthyroidism or hypothyroidism)
8)-3 respiratory disease
8)-4 pleural effusion or ascites
9)Diagnosed as any of the following disease or conditions.
9)-1 coronary artery disease
9)-2 administration of amiodarone
9)-3 severe valvular disease of the heart
9)-4 aortic disease
9)-5 bleeding disorder
10)Pregnant or lactating women, or desire to bear children.
11)Diagnosed as psychosis.
12)Diagnosed as any diseases currently treated with adrenal corticosteroids or immunosuppressants.
13)Not applicable isolation due to radiation control.
14)Episodes of allergic reaction to potassium iodide.
15)Any symptomatic lesions currently treated with palliative external irradiation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Seigo
Middle name
Last name Kinuya
Organization Kanazawa University
Division name Institute of Medical, Pharmaceutical and Health Sciences
Zip code 920-8641
Address 13-1, Takara-machi, Kanazawa
TEL 076-265-2333
Email kinuya@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Anri
Middle name
Last name Inaki
Organization Kanazawa University
Division name Institute of Medical, Pharmaceutical and Health Sciences
Zip code 920-8641
Address 13-1, Takara-machi, Kanazawa
TEL 076-265-2333
Homepage URL
Email henri@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Innovative Clinical Research Center, Kanazawa University
Address 13-1, Takara-machi, Kanazawa
Tel 076-265-2090
Email crc.irb-knz@esct.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 金沢大学附属病院(石川県)
鹿児島大学病院(鹿児島県)
北海道大学病院(北海道)
群馬大学医学部附属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 31 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/jmi/64/3.4/64_205/_article
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6527850/
Number of participants that the trial has enrolled 20
Results No DLT was found. There was no death event within 6 months after enrollment. However, one patient died due to disease progression.

No grade 4 adverse event or unexpected adverse reactions were found.

The response based on RECIST was 2 in CR, 13 in SD, 3 in PD, and 2 in NE. RR was 10%.

The scintigraphic response in the first course was 2 in CR, 5 in PR, 8 in SD, 4 in PD, and one in non-CR/non-PD. RR was 35%.

There was no death within 6 months of enrollment and OS and PFS were 100% and 80%, respectively.
Results date posted
2020 Year 02 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 05 Month 20 Day
Baseline Characteristics Sex (F:M) 6:14
Age 51.2 +- 14.4 (range: 21-76) years

Severe local invasion at initial diagnosis (25%, 5/20)
Metastasis at initial diagnosis (25%, 5/20)
Local recurrence after surgical resection (20%, 4/20)
Metastasis after surgical resection (65%, 13/20)
Participant flow We enrolled 20 patients between February 2016 and July 2017.
Adverse events Adverse reactions by PT
Thrombocytopenia 15/20, 75.0%
Loss of appetite 14/20, 70.0%
Lymphopenia 13/20, 65.0%
Nausea 10/20, 50.0%
Leukopenia 10/20, 50.0%
Outcome measures The best overall response rate based on RECIST was 10% (2/20) in complete response (CR), 65% (13/20) in stable disease (SD), 15% (3/20) in progressive disease (PD), and 10% (2/20) in not evaluated (NE). The response rate [partial response (PR) + CR] was 10%.
The scintigraphic response in the first course was 10%(2/20) in CR, 25% (5/20) in PR, 40% in SD (8/20), 20% in PD (4/20), and 5% in non-CR/non-PD (1/20). Response rate (PR + CR) was 35% (95% CI: 15.4-59.2%).
There was no death within 6 months of enrollment and overall survival (OS) rate was 100%. Four patients had progression events during the 6 months since enrollment and progression-free survival (PFS) at 6 months was 80.0%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 07 Month 30 Day
Date of IRB
2015 Year 10 Month 01 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 11 Month 30 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 30 Day
Last modified on
2020 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021402

Research Plan
Registered date File name
2016/04/03 01_160115_MIBG_protocol_1.3.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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