A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA

Phase 2Active Not RecruitingNCT05601232

Stella Pharma Corporation10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unresectable Angiosarcoma

Interventions

BNCTRADIATION

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Cancer Center Hospital

Tokyo, Japan

Outcomes

Primary Outcomes

Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT

Time frame: Baseline until Day90

Secondary Outcomes

Response rate as assessed by the investigator according to RECISTv1.1

Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT

Time frame: Baseline until Day90

Duration of response as assessed by the IRF and the investigator

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 frame: Baseline until disease progression or death

Time to response as assessed by the IRF

From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first

Time frame: Baseline until the initial occurrence of CR or PR

Complete response (CR) rate as assessed by the IRF and the investigator

Percentage of patients with CR for target lesions after BNCT

Time frame: Baseline until the initial occurrence of CR

Disease control rate as assessed by the IRF and the investigator

Percentage of patients with CR, PR and SD for target lesions after BNCT

Time frame: Baseline until the initial occurrence of CR, PR or SD

Overall response rate as assessed by the IRF and the investigator

Data from ClinicalTrials.gov

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