Malignant MelanomaNCT04293289
Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
A study testing CICS-1 (investigational device),SPM-011(investigational drug) in people with Malignant Melanoma and Angiosarcoma, run by Cancer Intelligence Care Systems, Inc. at 1 site in Japan.
Trial summary
Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Malignant Melanoma, Angiosarcoma
- What is being tested?
- CICS-1 (investigational device),SPM-011(investigational drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- 19 Nov 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
- Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
- Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
- Patients with lesions in the head, neck, chest, or extremities
- Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration
Who cannot join
- Patients with obvious disseminated lesions
- Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
- Patients with active lesions / active multiple cancers in addition to the target lesion
- Patients with infections that require systemic treatment.
- Patients with active implantable medical devices
- Patients with a history of BNCT treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.
- Conditions
- Malignant Melanoma, Angiosarcoma
- Being tested
- CICS-1 (investigational device),SPM-011(investigational drug)
- Keywords
- BNCT, Boron Neutron Capture Therapy, Borofalan, Melanoma, Angiosacronoma, skin cancer
- Medical subject headings
- Melanoma, Hemangiosarcoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CICS-1 (investigational device),SPM-011(investigational drug)Other
Intravenous administration of SPM-011 and neutron irradiation with CICS-1.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | BNCT(Boron Neutron Capture Therapy)
SPM-011 iv administrates at 200 mg/kg/hr for 2 hours before neutron irradiation. During neutoron irradiation with CICS-1, SPM-011 iv continues at 100mg/kg/hr. Receives: Other: CICS-1 (investigational device),SPM-011(investigational drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
Evaluate the safety at each dose level by the frequency of DLT occurrence
Measured: 90 days
Secondary outcomes (8)
The incidence of adverse events and failures
Evaluate the incidence of adverse events and failures during the study period
Measured: 180 days
Tumor shrinkage ratio, tumor best shrinkage ratio
Measured: 30, 60, 90, 180 days
Response rate
Measured: 30, 60, 90, 180 days
Progression-free survival
Measured: 30, 60, 90, 180 days
Survival length
Measured: 30, 60, 90, 180 days
Best response rate for target lesion
Measured: 30, 60, 90, 180 days
Progression-free period
Measured: 30, 60, 90, 180 days
Period until chronic adverse event
Measured: 30, 60, 90, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start19 Nov 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Intelligence Care Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stella Pharma Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293289
- Sponsor's protocol ID
- CNCT-001/SPM-011-JAM001
- Status last verified
- Nov 2022
- First submitted
- 25 Feb 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen S, Wang S, Zhou D, Wu X, Gao M, Wu J, Yang Y, Pan X, Wang N. A clinician's perspective on boron neutron capture therapy: promising advances, ongoing trials, and future outlook. Int J Radiat Biol. 2024;100(8):1126-1142. doi: 10.1080/09553002.2024.2373746. Epub 2024 Jul 10.
PubMed 38986056
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
- ClinicalTrials.gov ID
- NCT04293289
- Acronym / sponsor ID
- CNCT-001/SPM-011-JAM001
- Conditions
- Malignant Melanoma, Angiosarcoma
- Keywords
- BNCT, Boron Neutron Capture Therapy, Borofalan, Melanoma, Angiosacronoma, skin cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cancer Intelligence Care Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stella Pharma Corporation
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Other: CICS-1 (investigational device),SPM-011(investigational drug)BNCT(Boron Neutron Capture Therapy) SPM-011 iv administrates at 200 mg/kg/hr for 2 hours before neutron irradiation. During neutoron irradiation with CICS-1, SPM-011 iv continues at 100mg/kg/hr. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
- Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
- Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
- Patients with lesions in the head, neck, chest, or extremities
- Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration
Key exclusion criteria (6 listed)
- Patients with obvious disseminated lesions
- Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
- Patients with active lesions / active multiple cancers in addition to the target lesion
- Patients with infections that require systemic treatment.
- Patients with active implantable medical devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CICS-1 (investigational device),SPM-011(investigational drug)Intravenous administration of SPM-011 and neutron irradiation with CICS-1. | Other | Treatment |
Primary outcome
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
Time frame: 90 days
Evaluate the safety at each dose level by the frequency of DLT occurrence
8 secondary outcomes
The incidence of adverse events and failures
Time frame: 180 days
Tumor shrinkage ratio, tumor best shrinkage ratio
Time frame: 30, 60, 90, 180 days
Response rate
Time frame: 30, 60, 90, 180 days
Progression-free survival
Time frame: 30, 60, 90, 180 days
Survival length
Time frame: 30, 60, 90, 180 days
Best response rate for target lesion
Time frame: 30, 60, 90, 180 days
Progression-free period
Time frame: 30, 60, 90, 180 days
Period until chronic adverse event
Time frame: 30, 60, 90, 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 38986056Shen S, Wang S, Zhou D, Wu X, Gao M, Wu J, Yang Y, Pan X, Wang N. A clinician's perspective on boron neutron capture therapy: promising advances, ongoing trials, and future outlook. Int J Radiat Biol. 2024;100(8):1126-1142. doi: 10.1080/09553002.2024.2373746. Epub 2024 Jul 10.
- Individual participant dataSharing planned: No
Related trials for Malignant Melanoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingPhase 1
A Study of BI 3810944 in Patients With Advanced Cancer
Solid Tumours, Melanoma
Not yet recruitingPhase 1/2
Combination Immunotherapy Targeting Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CICS-1 (investigational device),SPM-011(investigational drug) in people with Malignant Melanoma and Angiosarcoma, run by Cancer Intelligence Care Systems, Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.