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

November 3, 2023 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Outpatient Center
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Fairview Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation - Main Campus
      • Mayfield Heights, Ohio, United States, 44124
        • Cleveland Clinic - Hillcrest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: artesunate ointment 40%
artesunate formulated as an ointment to be applied topically to the vulva
Experimental: 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.
Drug: artesunate ointment 40%
artesunate formulated as an ointment to be applied topically to the vulva
Experimental: 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.
Drug: artesunate ointment 40%
artesunate formulated as an ointment to be applied topically to the vulva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 15 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of artesunate ointment as assessed by number of participants with regression to VIN1 or less at week 15
Time Frame: 15 weeks
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.
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Frantz Viral Therapeutics, LLC

Investigators

  • Principal Investigator: Cornelia L Trimble, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2019

Primary Completion (Actual)

August 31, 2022

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J18169
  • IRB00196703 (Other Identifier: Johns Hopkins Medicine)
  • IRB 19 1353 (Other Identifier: Cleveland Clinic Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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