Clinical trial NCT05601232: A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA
Official title: A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Unresectable Angiosarcoma
Lead sponsor: Stella Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Cancer Intelligence Care Systems, Inc.
First posted: 2022-11-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Baseline until Day90
Secondary outcomes:
measure: Response rate as assessed by the investigator according to RECISTv1.1
timeFrame: Baseline until Day90
measure: Duration of response as assessed by the IRF and the investigator
timeFrame: Baseline until disease progression or death
measure: Time to response as assessed by the IRF
timeFrame: Baseline until the initial occurrence of CR or PR
measure: Complete response (CR) rate as assessed by the IRF and the investigator
timeFrame: Baseline until the initial occurrence of CR
measure: Disease control rate as assessed by the IRF and the investigator
timeFrame: Baseline until the initial occurrence of CR, PR or SD
measure: Overall response rate as assessed by the IRF and the investigator
timeFrame: Baseline until the initial occurrence of CR or PR
measure: Locoregional progression-free survival as assessed by the investigator
timeFrame: Baseline until in-field disease progression
measure: Extra-regional relapse-free survival as assessed by the investigator
timeFrame: Baseline until extra-field disease progression
measure: Progression-free survival as assessed by the IRF and the investigator
timeFrame: Baseline until disease progression or death
measure: Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator
timeFrame: Baseline until Day90
measure: Overall survival
timeFrame: Baseline until death
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
Study officials:
References: