Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).

Launched by ALPHA TAU MEDICAL LTD. · Dec 31, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for women with squamous cell carcinoma of the vulva, a type of skin cancer that can be newly diagnosed or have come back after previous treatment. The treatment involves a special device that delivers alpha radiation directly into the tumor to help shrink or eliminate it. The trial is not yet recruiting participants, but when it starts, it will be looking for women aged 18 and older who have tumors that are 7 centimeters or smaller and meet other specific health criteria.

To participate, women must have a confirmed diagnosis of vulvar squamous cell carcinoma and be willing to provide informed consent. They should also be in good enough health to tolerate the treatment, with certain blood test results falling within acceptable ranges. Participants can expect to receive this new radiation treatment and will be closely monitored for how well it works and any side effects. It's important to note that women who are pregnant or breastfeeding, or who have certain other health conditions, may not be eligible for this trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed newly diagnosed or recurrent (local) vulva SCC with or without distant metastases within 12 months
• • 2. Tumor size ≤ 7 centimeters in the longest diameter.
• • 3. Targeted lesion must be technically amenable for complete coverage (including margins) by the Alpha DaRT sources.
• • 4. Measurable target according to RECIST v1.1
• • 5. Interstitial implant indication validated by multidisciplinary team.
• • 6. ECOG Performance Status ≤3.
• • 7. Life expectancy ≥6 months.
• • 8. Women Age ≥18
• • 9. Willing and have the ability to provide signed Informed Consent.
• • 10. Willing to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
• 11. Blood tests values:
• • Leucocytes ≥3000mm3,
• • Absolute neutrophil count ≥1500mm3,
• • Platelets ≥100,000 mm3,
• • Total bilirubin ≤ 1.5xULN,
• • AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.
• • Creatinine ≤ 2.0xULN.
• • INR or Prothrombin time ≤1.5xULN.
• Exclusion Criteria:
• • 1. Concomitant chemotherapy or immunotherapy within the past 4 weeks
• • 2. Fit for surgical exploration unless the patient refuses surgery
• • 3. Known hypersensitivity to any of the components of the treatment.
• • 4. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
• • 5. Longest tumor diameter \>7 cm.
• • 6. Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
• • 7. Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
• • 8. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• • 9. Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of Alpha DaRT.
• • 10. 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 Alpha DaRT.
• • 11. High probability of protocol non-compliance (in opinion of investigator).
• • 12. Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
• • 13. Subjects not willing to sign an informed consent