RECRUITING

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

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Conditions

Recurrent Squamous Cell CarcinomaSquamous Cell CarcinomaAlpha emitting radiationCarcinoma, SquamousSkin CancerBrachytherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-09-21
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05323253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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
  2. 2. Central histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment
  3. 3. Measurable disease according to RECIST v 1.1.
  4. 4. Ability to undergo a CT scan
  5. 5. Tumor size ≤7 cm, at the longest diameter.
  6. 6. Single lesion per subject.
  7. 7. 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).
  8. 8. Interstitial implant indication validated by multidisciplinary team.
  9. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
  10. 10. Life expectancy ≥12 months.
  11. 11. Subjects male/ female ≥18.
  12. 12. Willing and have the ability to provide signed Informed Consent.
  13. 13. 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.
  14. 14. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
  15. 15. Blood tests values:
  16. * Leucocytes ≥3000mm3,
  17. * Absolute neutrophil count ≥1500mm3,
  18. * Platelets ≥100,000 mm3,
  19. * Total bilirubin ≤ 1.5xULN (upper limit of normal)
  20. * Aspartate Aminotransferase (AST) ≤2.5xULN,
  21. * Serum Glutamic-Oxaloacetic Transaminase (SGOT) ≤2.5xULN,
  22. * Serum Glutamic-Pyruvic Transaminase (SGPT) ≤2.5xULN,
  23. * Alkaline Phosphatase ≤2.5xULN.
  24. * Creatinine ≤ 2.0xULN or Creatinine Clearance ≥60 ml/min.
  25. * INR (International Normalized Ratio) or Prothrombin time ≤1.5xULN.
  1. 1. Distant or nodal metastatic disease (according to the TNM \[tumor, nodes , and metastases\] staging system - N+ or M1 patients are excluded).
  2. 2. T4 disease or perineural spread of disease
  3. 3. Previously untreated cutaneous SCC indicated for surgery or radiation.
  4. 4. Mucosal, vulvar, anal and penile SCC.
  5. 5. Inability to fully cover the entire volume with DaRT seeds
  6. 6. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs
  7. 7. Inability to undergo a CT scan
  8. 8. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
  9. 9. Patients receiving any of the following within 4 weeks of enrollment:
  10. 1. Antineoplastic systemic chemotherapy or biological therapy
  11. 2. Immunotherapy
  12. 3. Investigational agents other than the study intervention
  13. 4. Radiation therapy
  14. 5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.
  15. 10. Longest tumor diameter \>7 cm.
  16. 11. Tumor with keratoacanthoma histology.
  17. 12. Known hypersensitivity to any component of treatment.
  18. 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.
  19. 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.
  20. 15. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
  21. 16. High probability of protocol non-compliance (in opinion of investigator).
  22. 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.
  23. 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.
  24. 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.
  25. 20. Breastfeeding or pregnant women
  26. 21. Tattoos or other identifying marks which can not be adequately hidden on digital photos

Contacts and Locations

Study Contact

Liron Dimnik
CONTACT
+972-2-3737-210
LironD@alphatau.com
Aviya Hoida
CONTACT
+972-2-3737-210
aviyah@alphatau.com

Study Locations (Sites)

Banner Health MD Anderson Phoenix
Gilbert, Arizona, 85234
United States
Dignity Health Cancer Institute
Phoenix, Arizona, 85004
United States
Alliance Dermatology
Phoenix, Arizona, 85032
United States
UCLA
Los Angeles, California, 90095
United States
Day Star Skin and Cancer Center
DeLand, Florida, 32720
United States
Integrity Research Clinical Associates
Delray Beach, Florida, 33445
United States
Palm beach Dermatology Group
Delray Beach, Florida, 33484
United States
Palm Beach Dermatology Group
Delray Beach, Florida, 33484
United States
Hollywood Dermatology
Hollywood, Florida, 33021
United States
University of Miami
Miami, Florida, 33101
United States
Baptist Health South Florida MCI
Miami, Florida, 33176
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Beer Dermatology
West Palm Beach, Florida, 33401
United States
Emory University
Atlanta, Georgia, 30308
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Schweiger Dermatology Group
Hackensack, New Jersey, 07601
United States
New Mexico Cancer Center
Albuquerque, New Mexico, 87109
United States
Bassett Healthcare Network
Cooperstown, New York, 13326
United States
Northwell Health
Queens, New York, 11375
United States
New York Medical Skin Solutions
Rockaway Park, New York, 11694
United States
MDCS Dermatology
Smithtown, New York, 11787
United States
West Cancer Center
Germantown, Tennessee, 38138
United States
Gulf Coast Cancer Center
Houston, Texas, 77008
United States
University Cancer & Diagnostic Center
Houston, Texas, 77089
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
Dermatology of Seattle and Bellevue
Bellevue, Washington, 98004
United States

Collaborators and Investigators

Sponsor: Alpha Tau Medical LTD.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-21
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-09-21
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Squamous Cell Carcinoma
  • Recurrent Squamous Cell Carcinoma
  • Alpha emitting radiation
  • Carcinoma, Squamous
  • Skin Cancer
  • Brachytherapy

Additional Relevant MeSH Terms

  • Recurrent Squamous Cell Carcinoma