Status:
COMPLETED
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Frantz Viral Therapeutics, LLC
Conditions:
Vulvar Dysplasia
HPV-Related Vulvar Intraepithelial Neoplasia
Eligibility:
FEMALE
18-100 years
Phase:
PHASE1
Brief 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/...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03792516
Start Date
April 17 2019
End Date
December 3 2024
Last Update
December 4 2024
Active Locations (4)
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1
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21205
2
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States, 44111
3
Cleveland Clinic Foundation - Main Campus
Cleveland, Ohio, United States, 44195
4
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124