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

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ClinicalTrials.gov Identifier: NCT03792516
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Frantz Viral Therapeutics LLC
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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).

Condition or disease Intervention/treatment Phase
Vulvar Dysplasia HPV-Related Vulvar Intraepithelial Neoplasia Preinvasive Vulvar Disease Vulva Intraepithelial Neoplasia Vulvar Diseases Drug: artesunate ointment 40% Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : July 1, 2021

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




Primary Outcome Measures :
  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 [ 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is for vulvar intraepithelial neoplasia, therefore it is only offerred to women.
Accepts Healthy Volunteers:   Yes
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:

  • History of anal, vulvar, cervical or oropharyngeal HPV cancers
  • History of any other malignancy, except for non-melanoma skin lesions
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792516


Contacts
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Contact: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 410-955-8866 Jhcccro@jhmi.edu
Contact: Cornelia L Trimble, MD 410-502-0512 ctrimbl@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Outpatient Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Cornelia Trimble, MD    410-502-0512    ctrimbl@jhmi.edu   
Contact: Mihaela Paradis, BA    410-502-0512    mparadis@jhmi.edu   
Principal Investigator: Cornelia L Trimble, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Frantz Viral Therapeutics LLC
Investigators
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Principal Investigator: Cornelia L Trimble, MD Johns Hopkins University

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03792516     History of Changes
Other Study ID Numbers: J18169
IRB00196703 ( Other Identifier: JHM IRB )
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
artesunate
pre-invasive disease
treatment
alternative
non-surgical
cancer prevention
Additional relevant MeSH terms:
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Carcinoma in Situ
Vulvar Diseases
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Diseases, Female
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics