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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    9
  • sponsor
    Cancer Intelligence Care Systems, Inc.
Updated on 23 January 2021
cancer
skin lesion
angiosarcoma

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.

Details
Condition Hemangiosarcoma, melanoma, Sarcoma, Metastatic Melanoma, Sarcoma (Pediatric), Malignant Melanoma, Soft Tissue Sarcoma, angiosarcoma
Treatment CICS-1 (investigational device),SPM-011(investigational drug)
Clinical Study IdentifierNCT04293289
SponsorCancer Intelligence Care Systems, Inc.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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