Details

IRB Study Number 23-889

Status Recruiting

Institutes Taussig Cancer Institute, Obstetrics and Gynecology and Women's Health Institute

Description

Description

3.1 PRIMARY OBJECTIVE

To evaluate the histopathologic response after four 5-day cycles of artesunate ointment in adult women with biopsy-proven HPV-associated vulvar HSIL (usual type VIN) at the week 18 visit

3.2 SECONDARY OBJECTIVES

Efficacy:

• To evaluate the viral clearance after four 5-day cycles of topical artesunate ointment in adult women with biopsy-proven HPV-associated vulvar HSIL at week 18.

• To evaluate histopathologic partial response at the week 18 time point.

• To evaluate durability of documented complete responses throughout the study window (12 months)

• To evaluate surgical treatment durability for those with persistent disease at week 18, over the study window (12 months).

Safety:

To evaluate the safety of artesunate ointment for the treatment of vulvar HSIL

Inclusion Criteria

Inclusion Criteria

  • Adult women age ≥ 18 years

  • Capable of informed consent

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

  • Colposcopically-directed 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:

o Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN)

o Serum aspartate transaminase (SGOT/AST) < 5 x ULN

o Serum Bilirubin (total) < 2.5 x ULN

o Serum Creatinine ≤ 1.5 x ULN

  • Weight ≥ 50kg

Exclusion Criteria

Exclusion Criteria

  • Pregnant and nursing women

  • Concurrent anal, vulvar, or cervical cancer

  • CD4 count < 200 (HIV seropositive patients)

  • Subjects infected with HIV-1 will be excluded 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