Trial Title:
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
NCT ID:
NCT06075264
Condition:
Vulvar Diseases
HPV Infection
Vulvar HSIL
Pre-Cancerous Dysplasia
HPV Disease
VIN, Usual Type
VIN 2 of Usual Type
VIN 3 of Usual Type
Vin II
Vin III
VIN Grade 2
VIN Grade 3
High Grade Intraepithelial Neoplasia
Conditions: Official terms:
Papillomavirus Infections
Vulvar Diseases
Artesunate
Artenimol
Artemisinins
Artemisinin
Conditions: Keywords:
topical treatment
ointment
non-surgical
vulvar cancer prevention
high-risk HPV
human papillomavirus
HPV
vulvar HSIL
High grade lesions
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Double-blind, placebo-controlled randomized trial
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Double-blind, placebo controlled
Intervention:
Intervention type:
Drug
Intervention name:
Artesunate ointment
Description:
topical ointment, as a non-surgical treatment
Arm group label:
Artesunate ointment
Other name:
Artesunic acid
Other name:
Dihydroartemisinin (DHA)
Other name:
Artemisinin
Intervention type:
Drug
Intervention name:
Placebo ointment
Description:
topical placebo ointment
Arm group label:
Placebo ointment
Other name:
Placebo to artesunate ointment
Summary:
This is a phase II double-blind, placebo-controlled study of artesunate ointment for the
treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia
2/3).
Detailed description:
Eligible participants in this study are randomized 2:1 to receive either artesunate or
placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles
of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as
telehealth (ointment may be shipped directly to the patient). Participants are followed
closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult women age ≥ 18 years
- Capable of informed consent
- Able to collaborate with planned follow-up (transportation, compliance history, etc)
- Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL),
including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade
squamous intraepithelial lesion within the previous 3 months which was not excised
or otherwise treated may be accepted for study entry.
- Positive HPV test at study entry (any genotype).
- Women of childbearing potential agree to use birth control during the dosing phase
(through week 8).
- Laboratory values at Screening of:
- Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN)
- Serum aspartate transaminase (SGOT/AST) < 5 x ULN
- Serum Bilirubin (total) < 2.5 x ULN
- Serum Creatinine ≤ 1.5 x ULN
- Weight ≥ 50kg
Exclusion Criteria:
- Pregnant and nursing women
- Concurrent anal, vulvar, or cervical cancer
- HIV-positive participants with a CD4 count < 200
- Participants infected with HIV-1 if not on a stable, suppressive antiretroviral
therapy (ART) regimen.
- Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL
lesions, or to document histologic regression at a site where HSIL was present at
study entry.
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- Concomitant use of Efavirenz for HIV antiretroviral treatment
- Concomitant use of strong UGT inhibitors
- Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration
of the study
- Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion,
Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen
sclerosis or planus, atopic dermatitis, genital atrophy).
- Concurrent treatment with systemic corticosteroids
Gender:
Female
Gender based:
Yes
Gender description:
This study is only for biological females
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Florida Gynecologic Oncology
Address:
City:
Fort Myers
Zip:
33905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Edward C. Grendys, MD FACOG, FACS
Phone:
239-334-6626
Email:
Edward.Grendys@usa.genesiscare.com
Facility:
Name:
Cleveland Clinic Fairview Hospital
Address:
City:
Cleveland
Zip:
44111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Donna White
Phone:
216-445-8090
Email:
whited11@ccf.org
Contact backup:
Last name:
Megan Park
Phone:
216-445-8090
Email:
parkm2@ccf.org
Investigator:
Last name:
Chad Michener, MD
Email:
Principal Investigator
Investigator:
Last name:
Mariam AlHilli, MD
Email:
Sub-Investigator
Investigator:
Last name:
Steven Waggonner, MD
Email:
Sub-Investigator
Investigator:
Last name:
Robert DeBernardo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Roberto Vargas, MD
Email:
Sub-Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Donna White
Phone:
216-445-8090
Email:
whited11@ccf.org
Contact backup:
Last name:
Megan Park
Phone:
216-445-8090
Email:
parkm2@ccf.org
Investigator:
Last name:
Chad Michener, MD
Email:
Principal Investigator
Investigator:
Last name:
Lindsey Beffa, MD
Email:
Sub-Investigator
Investigator:
Last name:
Steven Waggonner, MD
Email:
Sub-Investigator
Investigator:
Last name:
Robert DeBernardo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Roberto Vargas, MD
Email:
Sub-Investigator
Investigator:
Last name:
Mariam AlHilli, MD
Email:
Sub-Investigator
Investigator:
Last name:
Johanna Kelley, MD
Email:
Sub-Investigator
Investigator:
Last name:
Daniel Margul, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michelle Kuznicki, MD
Email:
Sub-Investigator
Facility:
Name:
Hillcrest Hospital
Address:
City:
Mayfield Heights
Zip:
44124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Donna White
Phone:
216-445-8090
Email:
whited11@ccf.org
Contact backup:
Last name:
Megan Park
Phone:
216-445-8090
Email:
parkm2@ccf.org
Investigator:
Last name:
Chad Michener, MD
Email:
Principal Investigator
Investigator:
Last name:
Mariam AlHilli, MD
Email:
Sub-Investigator
Investigator:
Last name:
Steven Waggonner, MD
Email:
Sub-Investigator
Investigator:
Last name:
Robert DeBernardo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Roberto Vargas, MD
Email:
Sub-Investigator
Investigator:
Last name:
Lindsey Beffa, MD
Email:
Sub-Investigator
Start date:
December 6, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Frantz Viral Therapeutics, LLC
Agency class:
Industry
Collaborator:
Agency:
The Cleveland Clinic
Agency class:
Other
Source:
Frantz Viral Therapeutics, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075264
