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| Name | Class |
|---|---|
| Stella Pharma Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CICS-1 (investigational device),SPM-011(investigational drug) | Other | Intravenous administration of SPM-011 and neutron irradiation with CICS-1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of DLT(Dose Limiting Toxicity) occurence (Safety) | Evaluate the safety at each dose level by the frequency of DLT occurrence | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events and failures | Evaluate the incidence of adverse events and failures during the study period | 180 days |
| Tumor shrinkage ratio, tumor best shrinkage ratio | 30, 60, 90, 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Chuo Ku | Tokyo | 104-0045 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38986056 | Derived | Shen 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. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D006394 | Hemangiosarcoma |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Response rate | 30, 60, 90, 180 days |
| Progression-free survival | 30, 60, 90, 180 days |
| Survival length | 30, 60, 90, 180 days |
| Best response rate for target lesion | 30, 60, 90, 180 days |
| Progression-free period | 30, 60, 90, 180 days |
| Period until chronic adverse event | 30, 60, 90, 180 days |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009383 | Neoplasms, Vascular Tissue |