This phase I trial studies the side effects and best dose of artesunate in treating patients with high-grade anal intraepithelial neoplasia. Anal intraepithelial neoplasia are precancerous cells that may or may not become a cancer in the future. Most of the changes that lead to cancer are caused by human papillomavirus (HPV). Artesunate may kill cells infected with HPV.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03100045.
PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of intra-anal administration of artesunate, administered via suppository with 3 different schedules, in patients with high-grade anal intraepithelial neoplasia (AIN 2/3).
SECONDARY OBJECTIVES:
I. To measure the effect of intra-anal topical artesunate administration determined by pathology, based on the regression of AIN2/3 at study weeks 16, 32, and 40.
II. To evaluate the clearance of HPV as assessed by HPV genotype testing of cytologic specimens.
III. To create a tissue bank for future studies.
OUTLINE: This is a dose-escalation study. Patients are sequentially assigned to 1 of 2 groups.
GROUP I: Patients receive artesunate transanally once daily (QD) on days 1-5. Treatment repeats every 5 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients receive artesunate transanally QD on days 1-5. Treatment repeats every 5 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 16, 28, and 40 weeks.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorSandy Fang
