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

Malignant Melanoma Clinical Trial

Official title:

Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293289
• Other study ID #: CNCT-001/SPM-011-JAM001
• Status: Completed
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Cancer Intelligence Care Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angiosarcoma
• Malignant Melanoma
• Melanoma

Intervention

Other:
• CICS-1 (investigational device),SPM-011(investigational drug)
Intravenous administration of SPM-011 and neutron irradiation with CICS-1.

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo Ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Intelligence Care Systems, Inc.	Stella Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)	Evaluate the safety at each dose level by the frequency of DLT occurrence	90 days
Secondary	The incidence of adverse events and failures	Evaluate the incidence of adverse events and failures during the study period	180 days
Secondary	Tumor shrinkage ratio, tumor best shrinkage ratio		30, 60, 90, 180 days
Secondary	Response rate		30, 60, 90, 180 days
Secondary	Progression-free survival		30, 60, 90, 180 days
Secondary	Survival length		30, 60, 90, 180 days
Secondary	Best response rate for target lesion		30, 60, 90, 180 days
Secondary	Progression-free period		30, 60, 90, 180 days
Secondary	Period until chronic adverse event		30, 60, 90, 180 days