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CompletedNCT04293289Updated Feb 8, 2023

Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma

An interventional study of CICS-1 (investigational device),SPM-011(investigational drug) in Malignant Melanoma and Angiosarcoma, sponsored by Cancer Intelligence Care Systems, Inc.. Completed at 1 site in Japan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Cancer Intelligence Care Systems, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Malignant Melanoma
  • Angiosarcoma

Keywords

  • BNCT
  • Boron Neutron Capture Therapy
  • Borofalan
  • Melanoma
  • Angiosacronoma
  • skin cancer
03

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
  2. Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
  3. Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
  4. Patients with lesions in the head, neck, chest, or extremities
  5. Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration

Exclusion criteria

Exclusion Criteria:

  1. Patients with obvious disseminated lesions
  2. Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
  3. Patients with active lesions / active multiple cancers in addition to the target lesion
  4. Patients with infections that require systemic treatment.
  5. Patients with active implantable medical devices
  6. Patients with a history of BNCT treatment
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Other
    Treatment

    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.

    Other: CICS-1 (investigational device),SPM-011(investigational drug)

Interventions

  • OtherCICS-1 (investigational device),SPM-011(investigational drug)

    Intravenous administration of SPM-011 and neutron irradiation with CICS-1.

05

What researchers measure

Primary outcomes

  1. The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)

    Evaluate the safety at each dose level by the frequency of DLT occurrence

    Time frame: 90 days

Secondary outcomes

  1. The incidence of adverse events and failures

    Evaluate the incidence of adverse events and failures during the study period

    Time frame: 180 days

  2. Tumor shrinkage ratio, tumor best shrinkage ratio

    Time frame: 30, 60, 90, 180 days

  3. Response rate

    Time frame: 30, 60, 90, 180 days

  4. Progression-free survival

    Time frame: 30, 60, 90, 180 days

  5. Survival length

    Time frame: 30, 60, 90, 180 days

  6. Best response rate for target lesion

    Time frame: 30, 60, 90, 180 days

  7. Progression-free period

    Time frame: 30, 60, 90, 180 days

  8. Period until chronic adverse event

    Time frame: 30, 60, 90, 180 days

06

Study locations

1 site
  • National Cancer Center Hospital
    Chuo Ku, Tokyo 104-0045, Japan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04293289
Lead sponsor
Cancer Intelligence Care Systems, Inc.
Collaborators
Stella Pharma Corporation
Responsible party
Sponsor
First posted
Mar 3, 2020
Start date
Nov 19, 2019
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Feb 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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