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

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ClinicalTrials.gov Identifier: NCT04906070
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Hekabio

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

Condition or disease Intervention/treatment Phase
Breast Cancer Head and Neck Cancer Device: HB-001 Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Safety and Efficacy of Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan
Actual Study Start Date : May 25, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HB-001 DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
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.
Other Name: DaRT(Diffusing Alpha Radiation Emitters Therapy)




Primary Outcome Measures :
  1. Tumor response to HB-001 [ Time Frame: 9 - 11 weeks after HB-001 seed insertion ]
    Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 weeks after HB-001 insertion ]
    The incidence, frequency, severity and causality of adverse events related to the HB-001



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04906070


Contacts
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Contact: Toshiro Mabuchi +81-3-6205-7585 toshiro.mabuchi@hekabio.com

Locations
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Japan
Tohoku University Hospital Recruiting
Miyagi, Japan, 980-8574
Contact: Rei Umezawa, M.D., Ph.D.    +81-22-717-7000      
Principal Investigator: Rei Umezawa         
Kansai Medical University Hospital Recruiting
Osaka, Japan, 573-1191
Contact: Satoaki Nakamura, M.D., Ph.D.    +81-72-804-0101      
Principal Investigator: Satoaki Nakamura         
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Contact: Hiroshi Igaki, M.D., Ph.D.    +81-3-3542-2511      
Principal Investigator: Hiroshi Igaki, M.D., Ph.D.         
Tokyo Medical And Dental University Medical Hospital Recruiting
Tokyo, Japan, 113-8519
Contact: Kazuma Toda, M.D., Ph.D.    +81-3-3813-6111      
Principal Investigator: Kazuma Toda         
Sponsors and Collaborators
Hekabio
Investigators
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Study Director: Toshiro Mabuchi Hekabio
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Responsible Party: Hekabio
ClinicalTrials.gov Identifier: NCT04906070    
Other Study ID Numbers: HB-AT-001
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms