CompletedNot Applicable

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

Japan10 participantsStarted 2019-11-19

Plain-language 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.

Who can participate

Age range20 Years – 85 Years

SexALL

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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

What they're measuring

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

Timeframe: 90 days

Trial details

NCT IDNCT04293289

SponsorCancer Intelligence Care Systems, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Malignant Melanoma trials