Using Artesunate Vaginal Inserts to Treat Cervical Pre-Cancer
A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
PHASE2 · Frantz Viral Therapeutics, LLC · NCT04098744
This study is testing whether artesunate vaginal inserts can help women with cervical pre-cancer feel better and improve their condition.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 25 Years to 100 Years |
| Sex | Female |
| Sponsor | Frantz Viral Therapeutics, LLC (industry) |
| Locations | 7 sites (Fort Myers, Florida and 6 other locations) |
| Trial ID | NCT04098744 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the effectiveness of artesunate vaginal inserts in treating women with cervical high-grade intraepithelial neoplasia (CIN2/3). Participants are randomly assigned to receive either artesunate or a placebo over three 5-day cycles, with follow-up visits to assess treatment response and safety. The study includes telehealth options for dosing visits and requires participants to undergo a LEEP procedure at week 17 to evaluate histopathologic response. The primary goal is to determine the histopathologic response to the treatment, while secondary objectives focus on safety and viral clearance.
Who should consider this trial
Good fit: Ideal candidates are adult females aged 25 and older with biopsy-proven HPV-associated CIN2/3.
Not a fit: Patients who are pregnant, nursing, or have active autoimmune diseases or concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for women with CIN2/3, potentially preventing the progression to cervical cancer.
How similar studies have performed: Other studies have explored non-surgical treatments for CIN, but the use of artesunate vaginal inserts is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Fort Myers, Florida and 6 other locations
- Florida Gynecologic Oncology — Fort Myers, Florida, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States (RECRUITING)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
- Hillcrest Hospital — Mayfield Heights, Ohio, United States (RECRUITING)
- The Harris Health System (L.B.J Hospital) — Houston, Texas, United States (RECRUITING)
- University of Texas, M.D. Anderson — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Mihaela Plesa, BA, CCRP
- Email: FVTinfo@frantzgroup.com
- Phone: 440-255-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: CIN 2/3, HPV Infection, Pre-Cancerous Dysplasia, Cervical Dysplasia, HPV Related Disease, treatment study, cancer prevention, non-surgical