NCT04293289CompletedNot Applicable
Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Cancer Intelligence Care Systems, Inc.2 sites in 1 country10 target enrollmentStarted: November 19, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
Time Frame: 90 days
Evaluate the safety at each dose level by the frequency of DLT occurrence
Secondary Outcomes
- Progression-free period(30, 60, 90, 180 days)
- Tumor shrinkage ratio, tumor best shrinkage ratio(30, 60, 90, 180 days)
- Best response rate for target lesion(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)
- The incidence of adverse events and failures(180 days)
- Period until chronic adverse event(30, 60, 90, 180 days)
Investigators
Study Sites (2)
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