Phase 1 clinical trial of Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for Malignant melanoma and angiosarcoma
- Conditions
- Malignant Melanoma or Angiosarcoma
- Registration Number
- JPRN-jRCT1080224974
- Lead Sponsor
- Cancer Intelligence Care Systems, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>-Evaluate the safety of each dose level from the frequency of DLT occurrence<br>-Evaluate the incidence of adverse events and failures during the study period
- Secondary Outcome Measures
Name Time Method efficacy<br>-Tumor shrinkage rate, tumor best shrinkage rate<br>-Response rate<br>-Progression-free survival, survival period,best response rate for target lesion,locally progression-free period, period until chronic adverse event