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Official Title
A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Sponsor
Alpha Tau Medical LTD.
Enrollment
86
Timeline
Sep 2022 → Dec 2025
About This Study
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.
Eligibility Criteria
Inclusion Criteria
- 1Patients 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
- 2Central histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment
- 3Measurable disease according to RECIST v 1.1.
- 4Ability to undergo a CT scan
- 5Tumor size ≤7 cm, at the longest diameter.
- 6Single lesion per subject.
- 7Targeted 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).
- 8Interstitial implant indication validated by multidisciplinary team.
- 9Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
- 10Life expectancy ≥12 months.
- 11Subjects male/ female ≥18.
- 12Willing and have the ability to provide signed Informed Consent.
- 13Patients, 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.
- 14Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
- 15Blood tests values:
- 16Leucocytes ≥3000mm3,
- 17Absolute neutrophil count ≥1500mm3,
- 18Platelets ≥100,000 mm3,
- 19Total bilirubin ≤ 1.5xULN (upper limit of normal)
- 20Aspartate Aminotransferase (AST) ≤2.5xULN,
- 21Serum Glutamic-Oxaloacetic Transaminase (SGOT) ≤2.5xULN,
- 22Serum Glutamic-Pyruvic Transaminase (SGPT) ≤2.5xULN,
- 23Alkaline Phosphatase ≤2.5xULN.
- 24Creatinine ≤ 2.0xULN or Creatinine Clearance ≥60 ml/min.
- 25INR (International Normalized Ratio) or Prothrombin time ≤1.5xULN.
Exclusion Criteria
- 1Distant or nodal metastatic disease (according to the TNM \[tumor, nodes , and metastases\] staging system - N+ or M1 patients are excluded).
- 2T4 disease or perineural spread of disease
- 3Previously untreated cutaneous SCC indicated for surgery or radiation.
- 4Mucosal, vulvar, anal and penile SCC.
- 5Inability to fully cover the entire volume with DaRT seeds
- 6Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs
- 7Inability to undergo a CT scan
- 8Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- 9Patients receiving any of the following within 4 weeks of enrollment:
- 10Antineoplastic systemic chemotherapy or biological therapy
- 11Immunotherapy
- 12Investigational agents other than the study intervention
- 13Radiation therapy
- 14Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.
- 15Longest tumor diameter \>7 cm.
- 16Tumor with keratoacanthoma histology.
- 17Known hypersensitivity to any component of treatment.
- 18Clinically 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.
- 19Any 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.
- 20Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
- 21High probability of protocol non-compliance (in opinion of investigator).
- 22Volunteers 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.
- 23Has 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.
- 24Patients 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.
- 25Breastfeeding or pregnant women
- 26Tattoos or other identifying marks which can not be adequately hidden on digital photos
Locations
30 sites participating in this study
Emory University
Atlanta, Georgia 30308
Zachary Buchwald, MD
Banner Health MD Anderson Phoenix
Gilbert, Arizona 85234
Michael Samuels, MD
Dignity Health Cancer Institute
Phoenix, Arizona 85004
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →