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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04293289
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : August 3, 2021
Stella Pharma Corporation
Information provided by (Responsible Party):
Cancer Intelligence Care Systems, Inc.

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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Angiosarcoma Other: CICS-1 (investigational device),SPM-011(investigational drug) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Boron

Arm Intervention/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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. The incidence of adverse events and failures [ Time Frame: 180 days ]
    Evaluate the incidence of adverse events and failures during the study period

  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04293289

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Contact: Ryo Fujii +81-3-3529-6301

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National Cancer Center Hospital Recruiting
Chuo Ku, Tokyo, Japan, 104-0045
Contact: Jun Itami, MD    +81-3-3542-2511      
Sponsors and Collaborators
Cancer Intelligence Care Systems, Inc.
Stella Pharma Corporation
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Responsible Party: Cancer Intelligence Care Systems, Inc. Identifier: NCT04293289    
Other Study ID Numbers: CNCT-001/SPM-011-JAM001
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cancer Intelligence Care Systems, Inc.:
Boron Neutron Capture Therapy
skin cancer
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue