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

Primary Purpose

Vulvar Dysplasia, HPV-Related Vulvar Intraepithelial Neoplasia, Preinvasive Vulvar Disease

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
artesunate ointment 40%
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Dysplasia focused on measuring artesunate, pre-invasive disease, treatment, alternative, non-surgical, cancer prevention

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Outpatient Center
  • Cleveland Clinic Fairview Hospital
  • Cleveland Clinic Foundation - Main Campus
  • Cleveland Clinic - Hillcrest Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Artesunate ointment 40%, 1 cycle

Artesunate ointment 40%, 2 cycles

Artesunate ointment 40%, 3 cycles

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 2, 2019
Last Updated
October 31, 2022
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Frantz Viral Therapeutics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03792516
Brief Title
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
Acronym
ART-VIN
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Frantz Viral Therapeutics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artesunate ointment 40%, 1 cycle
Arm Type
Experimental
Arm Description
Patients enrolled in this treatment group will receive one 5-day cycle of artesunate ointment applied topically to the vulva at week 0.
Arm Title
Artesunate ointment 40%, 2 cycles
Arm Type
Experimental
Arm Description
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.
Arm Title
Artesunate ointment 40%, 3 cycles
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
artesunate ointment 40%
Intervention Description
artesunate formulated as an ointment to be applied topically to the vulva
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Effect of artesunate ointment as assessed by number of participants with regression to VIN1 or less at week 15
Description
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.
Time Frame
15 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is for vulvar intraepithelial neoplasia, therefore it is only offerred to women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia L Trimble, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Cleveland Clinic Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Foundation - Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic - Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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