Treatment of malignant skin tumors using alpha radiation emitters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of a novel treatment for malignant cutaneous tumors using a device that delivers diffusing alpha radiation emitters (DaRT) directly into the tumor. The study is prospective, open-label, and single-arm, involving multiple centers. Participants will have confirmed malignant skin lesions, and the treatment aims to reduce tumor size within 9-11 weeks following the insertion of radioactive seeds. Safety will be monitored through the assessment of adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:

  * SCC
  * BCC
  * Lentigo maligna melanoma (Dubreuilh melanoma)
  * Carcinosarcoma
* Acceptable tumor locations include the following:

  * Skin (facial, scalp, extremities, torso)
  * Lips
  * Eyelids
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
* 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.
* International normalized ratio of prothrombin time ≤1.8.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form

Exclusion Criteria:

* Subject has a tumor with histology of one of the following:

  * Keratoacanthoma
  * Merkel cell carcinoma
  * Sarcoma other than carcinosarcoma
* Metastatic disease (according to the TNM staging system - M1 patients are excluded)
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
* 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.

Where it's running

• CHU Grenoble Alpes
  Grenoble, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting

Study contacts

• Principal investigator: Dr Pascal POMMIER — Centre Leon Berard
• Study coordinator: Liron Dimnik
• Email: LironD@alphatau.com
• Phone: +972-2-373-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.