Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)

Vulvar Diseases Clinical Trial

— ART-VIN  

Official title:

A Phase I Proof-of-Concept Study of Artesunate Ointment for the Treatment of Patients With High-Grade Vulvar Intraepithelial Neoplasia (HSIL VIN 2/3)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03792516
• Other study ID #: J18169
• Secondary ID: IRB00196703IRB 1
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 17, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).

Description:

Phase I open-label dose escalation study of topical artesunate, formulated as ointment, in the treatment of adult females with biopsy-confirmed HSIL VIN2/3. Fifteen (15) subjects will undergo up to a total of three cycles of topical artesunate. The first cycle will be initiated on Day 0, the second at Week 2, and the third and final cycle at week 4.

Primary Objective:

To evaluate the safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions

To measure the effect of artesunate ointment on histologic regression of HSIL/VIN2/3 to VIN1 or less, confirmed by a colposcopically-directed biopsy, at study week 15.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.

• Females of childbearing potential: negative urine pregnancy test

• Ability to provide informed consent

• Ability to collaborate with planned follow-up (transportation, compliance history, etc.)

• Use of contraception through the study exit visit (week 28)

Exclusion Criteria:

• Concomitant use of any topical immune modulating agents e.g. imiquimod, Aldara ®

• Cluster of differentiation 4 (CD4) count < 200 at the time of screening for eligibility.

• Unable to provide informed consent

• Currently receiving systemic chemotherapy or radiation therapy for another cancer.

• Pregnant females

• Concurrent dermatological disorders involving the vulva (i.e., herpes, ulceration secondary to Crohn's disease) or vulvar dermatosis (i.e., lichen planus, lichen sclerosus, or lichen simplex chronicus);

• Women weighing less than 50 kg

Related Conditions & MeSH terms

• Carcinoma in Situ
• HPV-Related Vulvar Intraepithelial Neoplasia
• Neoplasms
• Preinvasive Vulvar Disease
• Vulva Intraepithelial Neoplasia
• Vulvar Diseases
• Vulvar Dysplasia

Intervention

Drug:
• artesunate ointment 40%
artesunate formulated as an ointment to be applied topically to the vulva

Locations

Country	Name	City	State
United States	Johns Hopkins Outpatient Center	Baltimore	Maryland
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Foundation - Main Campus	Cleveland	Ohio
United States	Cleveland Clinic - Hillcrest Hospital	Mayfield Heights	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Frantz Viral Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions as assessed by number of participants experiencing serious adverse events or dose-limiting toxicities	Number of participants with study-related serious adverse events or dose-limiting toxicities assessed using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria	15 weeks
Secondary	Effect of artesunate ointment as assessed by number of participants with regression to VIN1 or less at week 15	Number of participants with histologic regression of HSIL/VIN2/3 to VIN1 or less on colposcopically-directed biopsy, at study week 15 after receiving artesunate ointment therapy.	15 weeks