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NCT Number: NCT04293289

Boron Neutron Capture Therapy 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.

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Key information

Conditions

Malignant Melanoma Angiosarcoma Hemangiosarcoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CICS-1 (investigational device),SPM-011(investigational drug)

Other

Intravenous administration of SPM-011 and neutron irradiation with CICS-1.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cancer Intelligence Care Systems, Inc.

Industry

Collaborators

  • Stella Pharma Corporation

Registry information

Official study title

Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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