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

Sponsor

Cancer Intelligence Care Systems, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04293289

Collaborator

Stella Pharma Corporation (Industry)

Enrollment

Location

Arm

37.4

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Melanoma Angiosarcoma	Other: CICS-1 (investigational device),SPM-011(investigational drug)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 19, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Other: 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.

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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