Refractory pheochromocytoma (including paraganglioma)
Conditions
Interventions
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 cri
Sponsors
Kanazawa University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactAnri Inaki
Kanazawa University Institute of Medical, Pharmaceutical and Health Sciences
Outcome results
None listed