Malignant Melanoma or Angiosarcoma
Conditions
Interventions
investigational material(s)
Generic name etc : SPM-011(investigational drug), CICS-1 (investigational device)
INN of investigational material : Borofalan(10B)
Therapeutic category code : 429 Other a
Sponsors
Cancer Intelligence Care Systems, Inc
STELLA PHARMA CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 values in the latest screening test within 28 days of registration
Exclusion criteria
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 |
|---|---|
| safety -Evaluate the safety of each dose level from the frequency of DLT occurrence -Evaluate the incidence of adverse events and failures during the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy -Tumor shrinkage rate, tumor best shrinkage rate -Response rate -Progression-free survival, survival period,best response rate for target lesion,locally progression-free period, period until chronic adverse event | — |
Countries
Japan
Outcome results
None listed