Unresectable Angiosarcoma
Conditions
Brief 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.
Interventions
RADIATIONBNCT
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.
Sponsors
Cancer Intelligence Care Systems, Inc.
Stella Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Baseline until Day90 | Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response as assessed by the IRF and the investigator | Baseline until disease progression or death | From the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first, until confirmed disease progression or death, whichever occurred first |
| Time to response as assessed by the IRF | Baseline until the initial occurrence of CR or PR | From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first |
| Complete response (CR) rate as assessed by the IRF and the investigator | Baseline until the initial occurrence of CR | Percentage of patients with CR for target lesions after BNCT |
| Disease control rate as assessed by the IRF and the investigator | Baseline until the initial occurrence of CR, PR or SD | Percentage of patients with CR, PR and SD for target lesions after BNCT |
| Overall response rate as assessed by the IRF and the investigator | Baseline until the initial occurrence of CR or PR | Percentage of patients with CR or PR after BNCT |
| Response rate as assessed by the investigator according to RECISTv1.1 | Baseline until Day90 | Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT |
| Extra-regional relapse-free survival as assessed by the investigator | Baseline until extra-field disease progression | From the date of BNCT until confirmed extra-field disease progression (new lesions) |
| Progression-free survival as assessed by the IRF and the investigator | Baseline until disease progression or death | From the date of BNCT until confirmed disease progression or death, whichever occurred first |
| Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator | Baseline until Day90 | Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT |
| Overall survival | Baseline until death | From the date of BNCT until death from any causes |
| Locoregional progression-free survival as assessed by the investigator | Baseline until in-field disease progression | From the date of BNCT until confirmed in-field disease progression |
Countries
Japan
Outcome results
None listed