A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

Exclusion Criteria

• •1. Distant or nodal metastatic disease (according to the TNM \[tumor, nodes , and metastases\] staging system - N+ or M1 patients are excluded).
• •2. T4 disease or perineural spread of disease
• •3. Previously untreated cutaneous SCC indicated for surgery or radiation.
• •4. Mucosal, vulvar, anal and penile SCC.
• •5. Inability to fully cover the entire volume with DaRT seeds
• •6. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs
• •7. Inability to undergo a CT scan
• •8. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
• •9. Patients receiving any of the following within 4 weeks of enrollment:
• •1. Antineoplastic systemic chemotherapy or biological therapy
• •2. Immunotherapy
• •3. Investigational agents other than the study intervention
• •4. Radiation therapy
• •5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.
• •10. Longest tumor diameter \>7 cm.
• •11. Tumor with keratoacanthoma histology.
• •12. Known hypersensitivity to any component of treatment.
• •13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months.
• •14. Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol.
• •15. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
• •16. High probability of protocol non-compliance (in opinion of investigator).
• •17. 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.
• •18. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• •19. Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 3 months after the DaRT insertion visit.
• •20. Breastfeeding or pregnant women
• •21. Tattoos or other identifying marks which can not be adequately hidden on digital photos