UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018497 |
|---|---|
| Receipt number | 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 13:47:16 |
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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
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
henri@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021402
