A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Skin Cancer (Non-Melanoma)
Unknown Primary
18 Years and older, Male and Female
CTP-SCC-03 (primary)
NCI-2022-10859
Summary
This is a multi-center clinical study enrolling up to 86 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, as well as to assess the Duration of Response (DOR) 6 months from initial
response. Secondary objectives are to assess the safety of DaRT, and to assess the
progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR),
local control and quality of life (QOL) for patients treated with DaRT.
Objectives
This study is a prospective multicenter, pivotal, single arm, open label clinical study to
assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of patients
with recurrent cutaneous squamous cell carcinoma.
The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial
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. DaRT seeds will be inserted into recurrent Squamous Cell
Carcinoma (SCC) tumors and will be removed following 14-21 days.
The Objective Response Rate (ORR) will be determined based on the confirmed Best Overall
Response (BOR) following DaRT insertion. Duration of Response (DOR) will be assessed for up
to 6 months from initial response is documented. 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.
Eligibility
- Patients with recurrent cutaneous SCC histologically confirmed who have failed at least first line standard of care therapy who are not indicated for surgery and standard radiation therapy, or non alpha radiation brachytherapy technologies, and for whom no curative systemic treatment is available
- Central histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment
- Measurable disease according to RECIST v 1.1.
- Ability to undergo a CT scan
- Tumor size =7 cm, at the longest diameter.
- Single lesion per subject.
- Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye).
- Interstitial implant indication validated by multidisciplinary team.
- Eastern Cooperative Oncology Group (ECOG) Performance Status =2.
- Life expectancy =12 months.
- Subjects male/ female =18.
- Willing and have the ability to provide signed Informed Consent.
- Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 3 months after the DaRT insertion visit.
- Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
- Blood tests values:
- Leucocytes =3000mm3,
- Absolute neutrophil count =1500mm3,
- Platelets =100,000 mm3,
- Total bilirubin = 1.5xULN (upper limit of normal)
- Aspartate Aminotransferase (AST) =2.5xULN,
- Serum Glutamic-Oxaloacetic Transaminase (SGOT) =2.5xULN,
- Serum Glutamic-Pyruvic Transaminase (SGPT) =2.5xULN,
- Alkaline Phosphatase =2.5xULN.
- Creatinine = 2.0xULN or Creatinine Clearance =60 ml/min.
- INR (International Normalized Ratio) or Prothrombin time =1.5xULN.
Treatment Sites in Georgia
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