Clinical trial NCT04068155: Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
Official title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Cancer
Cutaneous Tumor
Cutaneous Metastasis
Keywords: Squamous Cell Carcinoma
Basal Cell Carcinoma
Skin Cancer
Skin Metastasis
Superficial Sarcoma
Alpha Radiation
Cutaneous Lesion
Brachytherapy
Radiotherapy
Lentigo maligna melanoma
Carcinosarcom
scalp cancer
Lip cancer
Eyelid cancer
SCC
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

Detailed description: This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness 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.

Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).

Eligibility criteria: 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.

Primary outcomes:
measure: The objective response rate to DaRT treatment
timeFrame: up to 9-11 weeks
Secondary outcomes:
measure: Tumor volume
timeFrame: up to 9-11 weeks
measure: DaRT seeds placement
timeFrame: Day of DaRT insertion procedure
measure: Change in quality of life as assessed by the Skindex-16 questionnaire
timeFrame: up to 9-11 weeks
measure: Disease-Free Survival (DFS) rate
timeFrame: up to 24 months
measure: Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire
timeFrame: up to 9-11 weeks
Other outcomes:
measure: Adverse Events
timeFrame: up to 24 months
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Dr Pascal POMMIER
role: PRINCIPAL_INVESTIGATOR
affiliation: Antoine Lacassagne Cancer Center
name: Pr Jean Michel HANNOUN LEVI
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Dr Camille VERRY
role: PRINCIPAL_INVESTIGATOR
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