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Clinical trial

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)

ID
Name
J18169
Description
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).
Trial arms
Trial start
2019-04-17
Estimated PCD
2022-08-31
Trial end
2024-10-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
artesunate ointment 40%
artesunate formulated as an ointment to be applied topically to the vulva
Arms:
Artesunate ointment 40%, 1 cycle, Artesunate ointment 40%, 2 cycles, Artesunate ointment 40%, 3 cycles
Size
15
Primary endpoint
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
15 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2023-11-07

1 organization

1 product

5 indications

Organization
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Product
Artesunate
Indication
Vulvar Dysplasia
Indication
HPV-related vulvar intraepithelial neoplasia
Indication
Preinvasive Vulvar Disease
Indication
Vulvar Intraepithelial Neoplasia
Indication
Vulvar Diseases