Overview

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