Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intravenous administration of SPM-011 and neutron irradiation with CICS-1.
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
Evaluate the safety at each dose level by the frequency of DLT occurrence
Time frame: 90 days
The incidence of adverse events and failures
Evaluate the incidence of adverse events and failures during the study period
Time frame: 180 days
Tumor shrinkage ratio, tumor best shrinkage ratio
Time frame: 30, 60, 90, 180 days
Response rate
Time frame: 30, 60, 90, 180 days
Progression-free survival
Time frame: 30, 60, 90, 180 days
Survival length
Time frame: 30, 60, 90, 180 days
Best response rate for target lesion
Time frame: 30, 60, 90, 180 days
Progression-free period
Time frame: 30, 60, 90, 180 days
Period until chronic adverse event
Time frame: 30, 60, 90, 180 days
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