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

A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma of the Vulva; Recurrent Carcinoma of the Vulva
• Intervention / Treatment: Device: DaRT seeds

Detailed Description

This is an prospective Open label, single arm, multi center, interventional study treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva .The study objectives are to collect data on the Feasibility and Safety of DaRT among patients who do not fit the entry of existing investigational trials.

The primary endpoint of the study is to evaluate the feasibility and safety of the Alpha DaRT sources for the treatment of vulva SCC. Feasibility will be determined according to the rate of successful placement of Alpha DaRT . Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.

The Secondary endpoint of the study will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liron Dimnik; Phone Number: +972542688602; Email: LironD@alphatau.com
• Study Contact Backup: Name: Aviya Hoida; Phone Number: +972547869466; Email: aviyah@alphatau.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DaRT Seeds; Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds	Device: DaRT seeds; An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - DaRT seed placement	Feasibility will be determined according to the rate of successful placement of Alpha DaRT	immediately following the insertion procedure
Safety - Adverse events	Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.	From day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy -Alpha DaRT seeds	The study's secondary objective will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1	1, 3, and 6 months post DaRT insertion].

Collaborators and Investigators

• Sponsor: Alpha Tau Medical LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 31, 2023
• First Submitted That Met QC Criteria: December 31, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Brachytherapy; Alpha emitting radiation; DaRT
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Disease Attributes; Neoplasms, Squamous Cell; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Carcinoma; Recurrence; Carcinoma, Squamous Cell; Vulvar Neoplasms
• Other Study ID Numbers: CTP-VUL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No