An interventional study of CICS-1 (investigational device),SPM-011(investigational drug) in Malignant Melanoma and Angiosarcoma, sponsored by Cancer Intelligence Care Systems, Inc.. Completed at 1 site in Japan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Cancer Intelligence Care Systems, Inc. · Not applicable, Interventional, and Treatment
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.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 2,649 interventional studies indexed under Melanoma.
Browse Melanoma studies →This is the only study on the registry with Cancer Intelligence Care Systems, Inc. as lead sponsor.
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Exclusion Criteria:
BNCT(Boron Neutron Capture Therapy) SPM-011 iv administrates at 200 mg/kg/hr for 2 hours before neutron irradiation. During neutoron irradiation with CICS-1, SPM-011 iv continues at 100mg/kg/hr.
Other: CICS-1 (investigational device),SPM-011(investigational drug)
Intravenous administration of SPM-011 and neutron irradiation with CICS-1.
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
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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