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Trial record 3 of 77 for:    Skin Cancer | Jerusalem, Israel

Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

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ClinicalTrials.gov Identifier: NCT04540588
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Tracking Information
First Submitted Date  ICMJE August 18, 2020
First Posted Date  ICMJE September 7, 2020
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE December 22, 2020
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • Tumor response to DaRT [ Time Frame: 9-11 weeks post DaRT insertion ]
    Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
  • Adverse events [ Time Frame: From conscent up to 9-11 weeks post DaRT insertion ]
    Frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • Change in tumor volume [ Time Frame: 9-11 weeks post DaRT insertion ]
    Based on imaging
  • Local control rate [ Time Frame: 9-11 weeks post DaRT insertion ]
    Will be assessed as the number of complete responses, partial responses and stable disease divided by the total numbers of tumors treated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 1, 2020)
Adverse Events [ Time Frame: From conscent up to 9-11 weeks post DaRT insertion ]
Incidence of all Adverse Events (AE) related and unrelated to the study treatment.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Retreatment With Intratumoral Diffusing Alpha Radiation Emitters
Official Title  ICMJE A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters
Brief Summary A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Detailed Description

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of re-treatment with 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 either recurrent or persistent disease following DaRT treatment. .

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Cancer
  • Mucosal Neoplasm of Oral Cavity
  • Soft Tissue Neoplasm
Intervention  ICMJE Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
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
Study Arms  ICMJE Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2020)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2024
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with histopathological confirmation of either recurrent or persistent disease following DaRT treatment.
  • Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
  • Target lesion technically amenable for full coverage with the Alpha DaRT seeds.
  • Brachytherapy indication validated by a multidisciplinary team.
  • Measurable disease according to RECIST v1.1.
  • Subjects over 18 years old.
  • Subjects' ECOG Performance Status Scale is < 2.
  • Subjects' life expectancy is more than 6 months.
  • Platelet count ≥100,000/mm3.
  • AST and ALT ≤ 2.5 X ULN
  • WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
  • International normalized ratio of prothrombin time ≤1.4 for patients not on Warfarin
  • Creatinine ≤2.3 mg/dL.
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
  • Subjects are willing to sign an informed consent form.

Exclusion Criteria:

  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
  • Known hypersensitivity to any of the components of the treatment.
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  • Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
  • Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
  • High probability of protocol non-compliance (in opinion of investigator)
  • Subjects not willing to sign an informed consent
  • Women who are pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adi Cohen +972-2-3737-212 adic@alphatau.com
Contact: Naama Barel +972-2-3737-210 naamab@alphatau.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04540588
Other Study ID Numbers  ICMJE CTP-CMN-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alpha Tau Medical LTD.
Study Sponsor  ICMJE Alpha Tau Medical LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aron Popovtzer, M.D Sharett institute, Hadassah Medical Center - Ein-Kerem
PRS Account Alpha Tau Medical LTD.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP