This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to: 1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion. 2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months. 3. Assess Local control up to 12 months after DaRT insertion.
This study is a multicenter, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of of Immunocompromised Patients with Cutaneous Squamous Cell Carcinoma The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. Alpha DaRT sources will be inserted into Cutaneous Squamous Cell Carcinoma tumors and will be removed following 14-21 days. The The objective response rate (ORR), which is calculated as the percent of patients achieving an objective response. Best overall response using the Response Evaluation Criteria in Solid Tumors guidelines (RECIST v1.1). Best overall response is assessed starting from DaRT removal. Safety will be assessed based on the cumulative incidence rate, severity and outcome of device related Adverse Events (AEs). Classification of AEs will be done according to CTCAE v5.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients
Banner Health
Gilbert, Arizona, United States
RECRUITINGUs Dermatology Parthners
Phoenix, Arizona, United States
RECRUITINGAlliance Dermatology
Phoenix, Arizona, United States
RECRUITINGIntegrity Research Clinical Associates
Boca Raton, Florida, United States
NOT_YET_RECRUITINGHollywood Dermatology
Hollywood, Florida, United States
RECRUITINGPalm Beach Dermatology Group
Palm Beach, Florida, United States
NOT_YET_RECRUITINGDay Star Skin Cancer Center
Poinciana, Florida, United States
NOT_YET_RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
NOT_YET_RECRUITINGBassett Healthcare
Cooperstown, New York, United States
RECRUITING...and 1 more locations
objective response rate
• Assessment of the objective response rate (ORR) determined by the best overall response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
Time frame: From Day 14 until 52 weeks
Progression Free Survival
• Determine Progression Free Survival (PFS) up to 12 months after DaRT seed insertion.
Time frame: Up to 12 months after DaRT seed insertion
Overall Survival
• Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.
Time frame: Up to 12 months after DaRT seed insertion
Local control
• Assess Local control up to 12 months after DaRT insertion.
Time frame: Up to 12 months after DaRT seed insertion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.