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

NCT ID: NCT03792516

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2024-12-03

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 VIN2/3).

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 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artesunate ointment 40%, 1 cycle

Patients enrolled in this treatment group will receive one 5-day cycle of artesunate ointment applied topically to the vulva at week 0.

Group Type: EXPERIMENTAL

artesunate ointment 40%

Intervention Type: DRUG

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

Artesunate ointment 40%, 2 cycles

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.

Group Type: EXPERIMENTAL

artesunate ointment 40%

Intervention Type: DRUG

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

Artesunate ointment 40%, 3 cycles

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.

Group Type: EXPERIMENTAL

artesunate ointment 40%

Intervention Type: DRUG

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

Interventions

artesunate ointment 40%

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Frantz Viral Therapeutics, LLC

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornelia L Trimble, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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

Countries

United States

Other Identifiers

IRB00196703

Identifier Type: OTHER

Identifier Source: secondary_id

IRB 19 1353

Identifier Type: OTHER

Identifier Source: secondary_id

J18169

Identifier Type: -

Identifier Source: org_study_id