Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3) (ART-VIN)
Vulvar Dysplasia, HPV-Related Vulvar Intraepithelial Neoplasia, Preinvasive Vulvar Disease
About this trial
This is an interventional treatment trial for Vulvar Dysplasia focused on measuring artesunate, pre-invasive disease, treatment, alternative, non-surgical, cancer prevention
Eligibility 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
Sites / Locations
- Johns Hopkins Outpatient Center
- Cleveland Clinic Fairview Hospital
- Cleveland Clinic Foundation - Main Campus
- Cleveland Clinic - Hillcrest Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Artesunate ointment 40%, 1 cycle
Artesunate ointment 40%, 2 cycles
Artesunate ointment 40%, 3 cycles
Patients enrolled in this treatment group will receive one 5-day cycle of artesunate ointment applied topically to the vulva at week 0.
Patients enrolled in this treatment group will receive two 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0 and 2.
Patients enrolled in this treatment group will receive three 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0, 2, and 4.