Angiosarcoma, Malignant Melanoma
Conditions
Keywords
BNCT, Boron Neutron Capture Therapy, Borofalan, Melanoma, Angiosacronoma, skin cancer
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.
Interventions
OTHERCICS-1 (investigational device),SPM-011(investigational drug)
Intravenous administration of SPM-011 and neutron irradiation with CICS-1.
Sponsors
Stella Pharma Corporation
Cancer Intelligence Care Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| The incidence of adverse events and failures | 180 days | Evaluate the incidence of adverse events and failures during the study period |
| 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 | — |
| Survival length | 30, 60, 90, 180 days | — |
Countries
Japan
Outcome results
None listed