JPRN-UMIN000018497Completed未知
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. - 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.
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Kanazawa University
- Enrollment
- 20
Study Overview
Brief Summary
o 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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
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.
Investigators
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