Clinical trial · Interventional
Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
NCT04293289CI-TRIAL-00063782completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Angiosarcoma | Angiosarcoma | ONTOLOGY_EXACT | 0.90 |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CICS-1 (investigational device),SPM-011(investigational drug) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- 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.
- interventionNames
- Other: CICS-1 (investigational device),SPM-011(investigational drug)
Primary outcomes (1)
- measure
- The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
- timeFrame
- 90 days
- description
- Evaluate the safety at each dose level by the frequency of DLT occurrence
Secondary outcomes (8)
- measure
- The incidence of adverse events and failures
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically 2. Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less 3. Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor 4. Patients with lesions in the head, neck, chest, or extremities 5. Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration Exclusion Criteria: 1. Patients with obvious disseminated lesions 2. Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion. 3. Patients with active lesions / active multiple cancers in addition to the target lesion 4. Patients with infections that require systemic treatment. 5. Patients with active implantable medical devices 6. Patients with a history of BNCT treatment
References
Publications (1)
- DERIVEDShen S, Wang S, Zhou D, Wu X, Gao M, Wu J, Yang Y, Pan X, Wang N. A clinician's perspective on boron neutron capture therapy: promising advances, ongoing trials, and future outlook. Int J Radiat Biol. 2024;100(8):1126-1142. doi: 10.1080/09553002.2024.2373746. Epub 2024 Jul 10. PMID 38986056