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

February 6, 2023 updated by: Cancer Intelligence Care Systems, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Intravenous administration of SPM-011 and neutron irradiation with CICS-1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse events and failures
Time Frame: 180 days
Evaluate the incidence of adverse events and failures during the study period
180 days
Tumor shrinkage ratio, tumor best shrinkage ratio
Time Frame: 30, 60, 90, 180 days
30, 60, 90, 180 days
Response rate
Time Frame: 30, 60, 90, 180 days
30, 60, 90, 180 days
Progression-free survival
Time Frame: 30, 60, 90, 180 days
30, 60, 90, 180 days
Survival length
Time Frame: 30, 60, 90, 180 days
30, 60, 90, 180 days
Best response rate for target lesion
Time Frame: 30, 60, 90, 180 days
30, 60, 90, 180 days
Progression-free period
Time Frame: 30, 60, 90, 180 days
30, 60, 90, 180 days
Period until chronic adverse event
Time Frame: 30, 60, 90, 180 days
30, 60, 90, 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Intelligence Care Systems, Inc.

Collaborators

Stella Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2019

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

March 1, 2020

First Posted (ACTUAL)

March 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNCT-001/SPM-011-JAM001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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