Artesunate Ointment for Vulvar Precancer

(ART-VIN IIB Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Frantz Viral Therapeutics, LLC

Must not be taking: Efavirenz, Strong UGT inhibitors, Imiquimod, others

Disqualifiers: Pregnancy, Cancer, HIV, others

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop my current medications for the trial?

You may need to stop certain medications to participate in this trial. Specifically, you cannot use Efavirenz for HIV treatment, strong UGT inhibitors, imiquimod, cidofovir, 5-fluorouracil, or systemic corticosteroids during the study.

How is the drug Artesunate ointment unique for treating vulvar precancer?

Artesunate ointment is unique because it is a topical treatment derived from an antimalarial drug that has shown potential anticancer effects, specifically targeting HPV-associated vulvar intraepithelial neoplasia (VIN) 2/3, which is a precancerous condition. Unlike other treatments, it is applied directly to the affected area, potentially offering a more localized and less invasive option. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adult women over 18 with a positive HPV test and biopsy-confirmed high-grade vulvar dysplasia (VIN2/3, HSIL). They must be able to consent, follow the study plan, not be pregnant or nursing, have no severe liver or kidney issues, weigh at least 50kg, and agree to use birth control. Excluded are those with low CD4 counts if HIV-positive, on certain HIV treatments or strong UGT inhibitors, using systemic corticosteroids or other cancer treatments.

Inclusion Criteria

Serum Bilirubin (total) < 2.5 x ULN

I understand the information given to me and can make decisions about my health care.

Able to collaborate with planned follow-up (transportation, compliance history, etc)

Exclusion Criteria

I am not taking any strong UGT inhibitors.

I am HIV-positive with a CD4 count below 200.

I do not have anal, vulvar, or cervical cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either artesunate or placebo ointment in four 5-day cycles at weeks 0, 2, 4, and 6

6 weeks

4 visits (in-person or virtual)

Follow-up

Participants are monitored with vulvar examinations or colposcopies at weeks 8, 18, 6-months, and 12-months

12 months

4 visits (in-person)

Treatment Details

Interventions

• Artesunate ointment (Anti-malarial Agent)

Trial Overview The study tests artesunate ointment versus placebo in treating HPV-associated vulvar HSIL. It's a phase II trial where participants don't know which treatment they're getting (double-blind) and neither do the researchers (placebo-controlled). The goal is to see if artesunate can effectively treat these lesions.

Participant Groups

Group I: Artesunate ointment Active Control 1 Intervention

Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks

Group II: Placebo ointment Placebo Group 1 Intervention

Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks

Artesunate ointment is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Artesunate for:

• Severe malaria

🇪🇺 Approved in European Union as Artesunate for:

• Malaria

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ascension St. Vincent Indianapolis, IN

Florida Gynecologic Oncology Fort Myers, FL

Cleveland Clinic Foundation Cleveland, OH

Cleveland Clinic Fairview Hospital Cleveland, OH

More Trial Locations

Who Is Running the Clinical Trial?

Frantz Viral Therapeutics, LLC Lead Sponsor

The Cleveland Clinic Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of artesunate after single oral administration to rats. [2019] Artesunate is a commonly used antimalarial drug derived from artemisinin. It is rapidly converted to dihydroartemisinin. Little is known on this conversion in the GI tract and blood, and how this influences absorption. In order to study the absorption phase of the kinetics of artesunate following oral administration in rats, samples were collected at baseline, and then 0.5, 2, 5, 10, 15, 30, 45, 60 and 120 minutes after a single dose of 150 mg.

2. Greece pubmed.ncbi.nlm.nih.gov

Progress on the study of the anticancer effects of artesunate. [2021] Artesunate (ART) is a derivative of artemisinin that is extracted from the wormwood plant Artemisia annua. ART is an antimalarial drug that has been shown to be safe and effective for clinical use. In addition to its antimalarial properties, ART has been attracting attention over recent years due to its reported inhibitory effects on cancer cell proliferation, invasion and migration. Therefore, ART has a wider range of potential clinical applications than first hypothesized. The aim of the present review was to summarize the latest research progress on the possible anticancer effects of ART, in order to lay a theoretical foundation for the further development of ART as a therapeutic option for cancer.

3. Netherlands pubmed.ncbi.nlm.nih.gov

A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer. [2018] Artesunate is an antimalarial agent with broad anti-cancer activity in in vitro and animal experiments and case reports. Artesunate has not been studied in rigorous clinical trials for anticancer effects.

4. England pubmed.ncbi.nlm.nih.gov

Stability and antiviral activity against human cytomegalovirus of artemisinin derivatives. [2018] Artesunate, a derivative of dihydroartemisinin, itself a product of artemisinin, inhibits the replication of cytomegalovirus in vitro. In vivo, artesunate undergoes rapid conversion into the active metabolite dihydroartemisinin. The in vitro stability of the compounds and the antiviral activity of dihydroartemisinin are of great concern for the interpretation of in vitro testing. The aim of the study was to measure artesunate conversion into dihydroartemisinin in culture medium and to evaluate the stability and antiviral activity of artemisinin derivatives, according to culture conditions.

5. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of topical artesunate for the treatment of vulvar intraepithelial neoplasia 2/3. [2023] To evaluate the safety, tolerability, and efficacy of topical artesunate ointment for treatment of biopsy-confirmed Human papillomavirus (HPV)-associated Vulvar intraepithelial neoplasia (VIN) 2/3.