This pilot phase I trial studies the side effects and best dose of artesunate in treating patients with high grade cervical intraepithelial neoplasia (abnormal and uncontrolled cell growth). Artesunate is a drug that acts against infections caused by the human papillomavirus and may help treat patients with high grade cervical intraepithelial neoplasia.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02354534.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of the intra-vaginal administration of artesunate in study subjects.
SECONDARY OBJECTIVES:
I. To explore clinical activity, such as clearance of human papillomavirus (HPV) disease, corresponding to intra-vaginal administration of artesunate.
OUTLINE: This is a dose-escalation study.
Patients receive artesunate intravaginally via suppository on day 0 and at weeks 2 and 4.
After completion of study treatment, patients are followed up at weeks 19, 28, and 41, and then every 3 months for up to 1 year.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorCornelia Liu Trimble