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

NCT ID: NCT06202339

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2026-12-31

Brief Summary

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.

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

Conditions

Carcinoma of the Vulva; Recurrent Carcinoma of the Vulva

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DaRT Seeds

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Group Type: EXPERIMENTAL

DaRT seeds

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alpha Tau Medical LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Liron Dimnik

Role: CONTACT

LironD@alphatau.com

+972542688602

Aviya Hoida

Role: CONTACT

aviyah@alphatau.com

+972547869466

Other Identifiers

CTP-VUL-01

Identifier Type: -

Identifier Source: org_study_id