Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma

Cancer Intelligence Care Systems

Status: Completed

Conditions: Angiosarcoma; Malignant Melanoma

Treatments: Other: CICS-1 (investigational device),SPM-011(investigational drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04293289

CNCT-001/SPM-011-JAM001

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Other group

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.

Treatment:

Other: CICS-1 (investigational device),SPM-011(investigational drug)