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

Not Applicable

Completed

• Conditions: Angiosarcoma; Malignant Melanoma
• Interventions: Other: CICS-1 (investigational device),SPM-011(investigational drug)

• Registration Number: NCT04293289
• Lead Sponsor: Cancer Intelligence Care Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-19
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-03-01
• Study First Posted: 2020-03-03
• Status Verified: 2022-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	CICS-1 (investigational device),SPM-011(investigational drug)	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.

Primary Outcome Measures

Name	Time	Method
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)	90 days	Evaluate the safety at each dose level by the frequency of DLT occurrence

Secondary Outcome Measures

Name	Time	Method
Tumor shrinkage ratio, tumor best shrinkage ratio	30, 60, 90, 180 days
Best response rate for target lesion	30, 60, 90, 180 days
Response rate	30, 60, 90, 180 days
Progression-free survival	30, 60, 90, 180 days
Survival length	30, 60, 90, 180 days
Progression-free period	30, 60, 90, 180 days
The incidence of adverse events and failures	180 days	Evaluate the incidence of adverse events and failures during the study period
Period until chronic adverse event	30, 60, 90, 180 days

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Tokyo, Japan