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

Study Overview
=================
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.

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

Conditions
-----------------
Malignant Melanoma, Angiosarcoma

Intervention / Treatment
-----------------
* Other: CICS-1 (investigational device),SPM-011(investigational drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>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)<br>* Intravenous administration of SPM-011 and neutron irradiation with CICS-1.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events and failures | Evaluate the incidence of adverse events and failures during the study period | 180 days | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BNCT, Boron Neutron Capture Therapy, Borofalan, Melanoma, Angiosacronoma, skin cancer