What side effects are associated with this type of intervention?

Common treatments for vulvar disease, such as topical idoxuridine and other topical antiviral or chemotherapeutic agents, generally have a favorable safety profile with minimal side effects. For instance, topical idoxuridine has been shown to be effective and non-toxic in treating vulvar condyloma acuminatum. However, other treatments like photodynamic therapy can have side effects including local skin reactions, pain, and potential long-term risks such as cutaneous malignancy. It is important to consult with a healthcare provider to understand the specific side effects associated with each treatment option.

What prior FDA approvals exist?

FDA-approved treatments for vulvar disease, particularly high-grade vulvar intraepithelial neoplasia (HSIL VIN2/3), include topical imiquimod, which acts as an immune response modifier. While not directly inducing apoptosis or inhibiting angiogenesis like artesunate, imiquimod stimulates the immune system to target abnormal cells. Other treatments may include surgical excision and laser therapy, but these do not share the same mechanism of action as artesunate. Currently, there are limited FDA-approved topical treatments specifically targeting apoptosis and angiogenesis in vulvar disease.

What other types of research exist?

Promising novel alternatives to topical artesunate for vulvar disease patients include: 1) Topical 5-fluorouracil, which has been used effectively in treating vulvar intraepithelial neoplasia. 2) Imiquimod 5% cream, an immune-response modifier that has shown efficacy in clearing genital warts and intraepithelial neoplasia. 3) Photodynamic therapy with agents like 5-aminolevulinic acid, which has been effective in treating various skin lesions, including those on the vulva. These treatments have demonstrated potential in clinical studies and may offer viable options for patients in 2024.

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Anti-metabolites

Artesunate Ointment for Vulvar Precancerous Lesions (ART-VIN Trial)

Phase 1

Waitlist Available

Led By Cornelia L Trimble, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of childbearing potential: negative urine pregnancy test

Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.

Must not have

Currently receiving systemic chemotherapy or radiation therapy for another cancer.

Women weighing less than 50 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 weeks

Awards & highlights

Summary

This trial tests a new ointment containing artesunate for treating pre-cancerous skin lesions on the vulva in adult women. The goal is to see if the ointment is safe and can reduce these lesions. The treatment involves applying the ointment multiple times over several weeks.

Who is the study for?

This trial is for women with a biopsy-confirmed diagnosis of high-grade vulvar dysplasia, including new and recurrent cases. Participants must be able to get pregnant but not currently be pregnant, use contraception through week 28, and commit to follow-up visits. Women under 50 kg or with certain other health conditions are excluded.

What is being tested?

The study is testing the safety and effectiveness of a topical ointment containing 40% artesunate in treating high-grade vulvar intraepithelial neoplasia (HSIL VIN2/3). It's an early-stage trial designed to see if this treatment could work and what side effects it might have.

What are the potential side effects?

Since this is a Phase I trial primarily focused on safety and tolerability, specific side effects of the artesunate ointment are being investigated. Potential side effects will become clearer as the study progresses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am of childbearing age and my pregnancy test is negative.

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I have been diagnosed with a severe precancerous condition of the vulva.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently undergoing chemotherapy or radiation for another cancer.

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I weigh less than 50 kg.

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I am not using any skin creams that affect the immune system.

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I have a skin condition affecting my vulva.

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I am unable to understand and agree to the study's details on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Artesunate ointment 40%, 3 cyclesExperimental Treatment1 Intervention

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.

Group II: Artesunate ointment 40%, 2 cyclesExperimental Treatment1 Intervention

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.

Group III: Artesunate ointment 40%, 1 cycleExperimental Treatment1 Intervention

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Vulvar Disease, such as topical artesunate, work by inducing apoptosis (programmed cell death) and inhibiting angiogenesis (formation of new blood vessels), which are crucial for controlling abnormal cell growth and reducing lesion size. These mechanisms are particularly important for patients as they target the underlying pathological processes, potentially leading to more effective and targeted therapies with fewer side effects compared to traditional treatments. This approach can improve patient outcomes by directly addressing the disease at a cellular level, thereby reducing symptoms and preventing progression.

Peruvoside targets apoptosis and autophagy through MAPK Wnt/β-catenin and PI3K/AKT/mTOR signaling pathways in human cancers.