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

NCT04293289 | Completed

• 1 other identifier: CNCT-001/SPM-011-JAM001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Melanoma; Angiosarcoma

Keywords

BNCT; Boron Neutron Capture Therapy; Borofalan; Melanoma; Angiosacronoma; skin cancer

Outcome Measures

Primary Outcomes (1)

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

  Evaluate the safety at each dose level by the frequency of DLT occurrence

  90 days

Secondary Outcomes (8)

• The incidence of adverse events and failures

  180 days

• Tumor shrinkage ratio, tumor best shrinkage ratio

  30, 60, 90, 180 days

• Response rate

  30, 60, 90, 180 days

• Progression-free survival

  30, 60, 90, 180 days

• Survival length

  30, 60, 90, 180 days

Study Arms (1)

Treatment

OTHER

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)

Interventions

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

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

Treatment

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Intelligence Care Systems, Inc.: lead
• Stella Pharma Corporation: collaborator

Study Sites (1)

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

Location

MeSH Terms

Conditions

Melanoma; Hemangiosarcoma; Skin Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 3, 2020
• Study Start: November 19, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)