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Trial Title:
Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA
NCT ID:
NCT06603987
Condition:
Thoracic Solid Malignant Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Esophageal Cancer
Non Small Cell Lung Cancer
Breast Cancer
Malignant Soft Tissue Sarcoma
Malignant Pleural Mesothelioma
Malignant Peripheral Nerve Sheath Tumors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet 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)
Intervention type:
Diagnostic Test
Intervention name:
［18F］FBPA
Description:
Intravenous injection of ［18F］FBPA and radiation exposure from PET-CT scan.
Arm group label:
Boron Neutron Capture Therapy (BNCT)
Summary:
To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients
with recurrent thoracic solid tumors that are difficult to treat with standard radiation
therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal
cord," and "esophagus" as common risk organs in the treatment plan for BNCT using
therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable
and recurrent thoracic solid tumors which are difficult to treat with standard radiation
and drug therapy.
To evaluate the safety of ［18F］FBPA synthesized with MPS200FBPA. In addition, the
usefulness of ［18F］FBPA-PET testing to determine the appropriateness of performing BNCT
will be evaluated in an exploratory manner.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Written informed consent must be obtained from the subject.
- Patients with histopathological diagnosed malignant tumor (except cutaneous
angiosarcoma)
- Measurable disease, as defined by RECIST v1.1.
- Patients diagnosed with recurrent malignant tumors that are unresectable and
perceived challenging to treat with standard treatment.
- Patients with ECOG performance status score of 0 or 1.
- Patients whose longest diameter sum of the lesions to be treated is 15 cm or less.
Exclusion Criteria:
- Patients with active disease or active double cancers other than target lesions.
- Patients with imaging findings that affect imaging evaluation of the tumor, such as
ground-glass opacities
- Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the
target lesion.
- Any serious concomitant disease that precludes completion of the study treatment.
- Patients with remaining complications of Grade 3 or higher related to prior
radiation therapy in the irradiation field.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-ku
Address:
City:
Osaka
Zip:
541-0043
Country:
Japan
Contact:
Last name:
Toshimitsu Hayashi
Phone:
+81-6-4707-1516
Email:
sp-chiken@stella-pharma.co.jp
Contact backup:
Last name:
Clinical trials information
Phone:
+81-6-4707-1516
Email:
sp-chiken@stella-pharma.co.jp
Start date:
January 1, 2025
Completion date:
October 31, 2028
Lead sponsor:
Agency:
Stella Pharma Corporation
Agency class:
Industry
Collaborator:
Agency:
Cancer Intelligence Care Systems, Inc.
Agency class:
Industry
Collaborator:
Agency:
Sumitomo Heavy Industries, Ltd.
Agency class:
Other
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/NCT06603987
