Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).

Participants who receive placebo in this study have the option to receive active drug (artesunate) after their week 15 colposcopy visit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frantz Viral Therapeutics, LLC; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Amarex Clinical Research; Frantz Viral Therapeutics LLC; Harris Health System (L.B.J. Hospital); M.D. Anderson Cancer Center; The Cleveland Clinic
• Treatments: Artemisinin; Artemisinine; Artemisinins; Artesunate

Criteria

Inclusion Criteria:

• Adult females age ≥ 25 years

• Capable of informed consent

• Any HPV genotype detectable by DNA test/HPV genotyping

• Colposcopically-directed, histologically confirmed tissue diagnosis of either CIN2, CIN3, or CIN2/3

• Women of childbearing potential agree to use birth control through week 28 of the study.

• Weight ≥ 50kg

Exclusion Criteria:

• Pregnant and nursing women

• Active autoimmune disease

• Taking immunosuppressive medication

• HIV seropositivity

• Immunocompromised subjects

• Evidence of concurrent cervical adenocarcinoma in situ

• Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects