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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Frantz Viral Therapeutics LLC; Frantz Viral Therapeutics, LLC
• Treatments: Artemisinins; Artesunate

Criteria

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