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

NCT03792516 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: J18169IRB00196703IRB 19 1353
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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).

Conditions

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

Keywords

artesunate; pre-invasive disease; treatment; alternative; non-surgical; cancer prevention

Outcome Measures

Primary Outcomes (1)

• 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

  15 weeks

Secondary Outcomes (1)

• Effect of artesunate ointment as assessed by number of participants with regression to VIN1 or less at week 15

  15 weeks

Study Arms (3)

Artesunate ointment 40%, 1 cycle

EXPERIMENTAL

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

Drug: artesunate ointment 40%

Artesunate ointment 40%, 2 cycles

EXPERIMENTAL

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.

Drug: artesunate ointment 40%

Artesunate ointment 40%, 3 cycles

EXPERIMENTAL

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.

Drug: artesunate ointment 40%

Interventions

artesunate ointment 40% DRUG

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

Artesunate ointment 40%, 1 cycle; Artesunate ointment 40%, 2 cycles; Artesunate ointment 40%, 3 cycles

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: This study is for vulvar intraepithelial neoplasia, therefore it is only offerred to women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Frantz Viral Therapeutics, LLC: collaborator

Study Sites (4)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21205, United States

Location

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation - Main Campus

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic - Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

MeSH Terms

Conditions

Vulvar Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Cornelia L Trimble, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 3, 2019
• Study Start: April 17, 2019
• Primary Completion: August 31, 2022
• Study Completion: December 3, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)