Cervical Dysplasia, CIN 2/3, HPV Infection, HPV Related Disease, Pre-Cancerous Dysplasia
Conditions
Keywords
treatment study, cancer prevention, non-surgical, HPV related disease, CIN, topical treatment, vaginal inserts, artesunate, artemisinin, non-invasive, high risk HPV, vaginal suppository
Brief 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).
Detailed description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17. Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3. Secondary Objectives: * To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3 * To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3. * To evaluate viral clearance after three 5-day cycles of artesunate and the LEEP procedure
Interventions
DRUGArtesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
Placebo for artesunate vaginal inserts
Sponsors
Amarex Clinical Research
M.D. Anderson Cancer Center
Harris Health System (L.B.J. Hospital)
The Cleveland Clinic
University of Michigan
Florida Gynecologic Oncology
Frantz Viral Therapeutics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants, study team, and sponsor are blinded to the treatment assignment.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 100 Years
Healthy volunteers
No
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 cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3) * Women of childbearing potential agree to use birth control through week17 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with histologic regression by week 17 | 17 weeks | Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17 | 17 weeks | Number of participants who had HPV strains detected at study entry which become undetectable by week 17 |
| Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure. | 40 weeks | Number of participants who had HPV strains detected at study entry which become undetectable after three 5-day cycles of artesunate and the LEEP procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment-Emergent Adverse Events (TEAE) | 6 weeks | Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention |
| Number of participants who withdrew from the study due to TEAEs | 6 weeks | Number of participants who were withdrawn from the study due to adverse events related to the study drug |
Countries
United States
Contacts
Primary ContactMihaela Plesa, BA, CCRP
Backup ContactAhmad Bayat, MD
Outcome results
None listed