Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

Breast Cancer Clinical Trial

Official title:

Study of the Safety and Efficacy of Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906070
• Other study ID #: HB-AT-001
• Status: Completed
• Phase: N/A
• Start date: May 25, 2019
• Est. completion date: May 27, 2022

Study information

• Verified date: June 2022
• Source: Hekabio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT)

Description:

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds. Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 27, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Head and neck cancer or breast cancer patients with histopathological proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment.

2. Tumor size is 5 cm or less in the longest diameter

3. Age 18 years or older

4. Eastern Cooperative Oncology Group performance status is 2 or less

5. Life expectancy: 6 months or longer

6. Vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable

7. Platelet count >= 100,000/mm3 and prothrombin time Prothrombin Time-International Normalized Ratio <= 1.8

8. Women of childbearing potential have to be confirmed not pregnant by a pregnancy test and have to agree to prevent conception throughout the study.

9. Having received explanation about the study, consented to participate in the study and signed the informed consent form.

10. Measurable disease according to RECIST v1.1

Exclusion Criteria:

1. The size of the tumor more than 5 cm in the maximum diameter.

2. ECOG performance status is 3 or higher

3. Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids.

4. History of serious allergy to the medicine for the treatments like anesthesia.

5. There are tumors to be preferentially treated such as metastatic lesion other than the target tumor

6. Having received chemotherapeutic drugs (except hormonal agents), immunotherapeutic agents, and molecular targeting agents in the past 30 days, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.

7. Having received immune checkpoint inhibitor in the past 2 months, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.

8. Having participated in different clinical studies in the past 30 days, which may affect the assessment of the safety or efficacy of HB-001 brachytherapy

9. Pregnant women or breast-feeding mothers

10. Those who do not wish to sign the informed consent form

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• HB-001
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Locations

Country	Name	City	State
Japan	Tohoku University Hospital	Miyagi
Japan	Kansai Medical University Hospital	Osaka
Japan	National Cancer Center Hospital	Tokyo
Japan	Tokyo Medical And Dental University Medical Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Hekabio

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response to HB-001	Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)	9 - 11 weeks after HB-001 seed insertion
Secondary	Adverse Events	The incidence, frequency, severity and causality of adverse events related to the HB-001	12 weeks after HB-001 insertion