Status:
COMPLETED
Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Lead Sponsor:
Cancer Intelligence Care Systems, Inc.
Collaborating Sponsors:
Stella Pharma Corporation
Conditions:
Malignant Melanoma
Angiosarcoma
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
- Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
- Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
- Patients with lesions in the head, neck, chest, or extremities
- Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration
Exclusion
- Patients with obvious disseminated lesions
- Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
- Patients with active lesions / active multiple cancers in addition to the target lesion
- Patients with infections that require systemic treatment.
- Patients with active implantable medical devices
- Patients with a history of BNCT treatment
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04293289
Start Date
November 19 2019
End Date
December 31 2022
Last Update
February 8 2023
Active Locations (1)
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1
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan, 104-0045