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Trial Title:
A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA
NCT ID:
NCT05601232
Condition:
Unresectable Angiosarcoma
Conditions: Official terms:
Hemangiosarcoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
BNCT
Description:
Patients will be infused SPM-011 intravenously at a dose of 200mg/kg/hr over 2 hours.
Thereafter, patient will be infused SPM-011 intravenously at a dose of 100mg/kg/hr and
will receive neutron irradiation simultaneously for a certain period of time based on his
Boronophenylalanine (BPA) concentration in the blood.
Arm group label:
Boron Neutron Capture Therapy (BNCT)
Summary:
The purpose of the study is to investigate efficacy and safety Boron Neutron Capture
Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with
lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT
developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Written informed consent must be obtained from the subject.
- Histologically documented primary skin angiosarcoma.
- Locally advanced or locally recurrent angiosarcoma, and not eligible for curative
surgery, chemoradiotherapy or radiotherapy. (Including cases where the individual
refuses treatment.)
- Measurable disease, as defined by RECIST v1.1.
- The longest diameter of the entire target lesion is 15 cm or less.
- ECOG performance status score of Grade 0 to 2
Exclusion Criteria:
- Apparent disseminated tumor lesions.
- Hereditary fructose intolerance.
- Phenylketonuria.
- Any serious concomitant disease that precludes completion of the study treatment.
- The target lesion has received radiation exceeding 75 Gy.
Gender:
All
Minimum age:
18 Years
Maximum age:
89 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Country:
Japan
Start date:
November 1, 2022
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Stella Pharma Corporation
Agency class:
Industry
Collaborator:
Agency:
Cancer Intelligence Care Systems, Inc.
Agency class:
Industry
Source:
Stella Pharma Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05601232
