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

Primary Purpose

Malignant Melanoma, Angiosarcoma

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
CICS-1 (investigational device),SPM-011(investigational drug)
Sponsored by
Cancer Intelligence Care Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring BNCT, Boron Neutron Capture Therapy, Borofalan, Melanoma, Angiosacronoma, skin cancer

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
Evaluate the safety at each dose level by the frequency of DLT occurrence

Secondary Outcome Measures

The incidence of adverse events and failures
Evaluate the incidence of adverse events and failures during the study period
Tumor shrinkage ratio, tumor best shrinkage ratio
Response rate
Progression-free survival
Survival length
Best response rate for target lesion
Progression-free period
Period until chronic adverse event

Full Information

First Posted
February 25, 2020
Last Updated
February 6, 2023
Sponsor
Cancer Intelligence Care Systems, Inc.
Collaborators
Stella Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04293289
Brief Title
Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Official Title
Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Intelligence Care Systems, Inc.
Collaborators
Stella Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma, Angiosarcoma
Keywords
BNCT, Boron Neutron Capture Therapy, Borofalan, Melanoma, Angiosacronoma, skin cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CICS-1 (investigational device),SPM-011(investigational drug)
Intervention Description
Intravenous administration of SPM-011 and neutron irradiation with CICS-1.
Primary Outcome Measure Information:
Title
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
Description
Evaluate the safety at each dose level by the frequency of DLT occurrence
Time Frame
90 days
Secondary Outcome Measure Information:
Title
The incidence of adverse events and failures
Description
Evaluate the incidence of adverse events and failures during the study period
Time Frame
180 days
Title
Tumor shrinkage ratio, tumor best shrinkage ratio
Time Frame
30, 60, 90, 180 days
Title
Response rate
Time Frame
30, 60, 90, 180 days
Title
Progression-free survival
Time Frame
30, 60, 90, 180 days
Title
Survival length
Time Frame
30, 60, 90, 180 days
Title
Best response rate for target lesion
Time Frame
30, 60, 90, 180 days
Title
Progression-free period
Time Frame
30, 60, 90, 180 days
Title
Period until chronic adverse event
Time Frame
30, 60, 90, 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
National Cancer Center Hospital
City
Chuo Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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