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

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byCornelia L Trimble, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cornelia L Trimble, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

See 2 more

Exclusion Criteria

Pregnant females

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

I weigh less than 50 kg.

See 4 more

Treatment Details

Interventions

Artesunate Ointment (Anti-metabolites)

Trial OverviewThe 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.

Participant Groups

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.