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

NCT ID: NCT04293289

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2022-12-31

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 will be determined.

Conditions

Malignant Melanoma; Angiosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: OTHER

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

Intervention Type: OTHER

Intravenous administration of SPM-011 and neutron irradiation with CICS-1.

Interventions

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

Intravenous administration of SPM-011 and neutron irradiation with CICS-1.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stella Pharma Corporation

INDUSTRY

Sponsor Role: collaborator

Cancer Intelligence Care Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Countries

Japan

Other Identifiers

CNCT-001/SPM-011-JAM001

Identifier Type: -

Identifier Source: org_study_id