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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins15 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vulvar Dysplasia HPV-Related Vulvar Intraepithelial Neoplasia Preinvasive Vulvar Disease Vulva Intraepithelial Neoplasia Vulvar Diseases

Interventions

artesunate ointment 40%DRUG

artesunate formulated as an ointment to be applied topically to the vulva

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

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, United States

Outcomes

Primary Outcomes

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

Time frame: 15 weeks

Secondary Outcomes

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.

Time frame: 15 weeks

Data from ClinicalTrials.gov

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