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A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA
Sponsor: Stella Pharma Corporation
Summary
The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.
Official title: A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2022-11-01
Completion Date
2025-08-31
Last Updated
2025-04-09
Healthy Volunteers
No
Conditions
Interventions
BNCT
Patients will be infused SPM-011 intravenously at a dose of 200mg/kg/hr over 2 hours. Thereafter, patient will be infused SPM-011 intravenously at a dose of 100mg/kg/hr and will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.
Locations (1)
National Cancer Center Hospital
Tokyo, Japan