Artesunate Vaginal Inserts for Cervical Dysplasia
(ART-CIN_IIB Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Frantz Viral Therapeutics, LLC
Must not be taking: Immunosuppressants
Disqualifiers: Pregnancy, Autoimmune disease, HIV, others
Prior Safety Data
Breakthrough Therapy
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking immunosuppressive medication.
Is artesunate safe for human use?
Artesunate, used in malaria treatment, has been tested in pregnant women and was well tolerated with no drug-related adverse effects. In trials for cervical and vulvar conditions, artesunate was evaluated for safety and showed promise, but more research is needed to confirm its safety for these specific uses.
12345How is the drug Artesunate unique for treating cervical dysplasia?
Artesunate vaginal inserts for cervical dysplasia are unique because they use an artemisinin derivative, which is different from the commonly used prostaglandin-based treatments like dinoprostone for cervical conditions. This treatment offers a novel approach by potentially leveraging the anti-inflammatory and anti-cancer properties of artesunate, which are not typical of standard cervical dysplasia treatments.
678910Eligibility Criteria
This trial is for adult women aged 25 or older with a biopsy-confirmed diagnosis of high-grade cervical lesions (CIN2/3), weighing at least 50kg, and not pregnant or breastfeeding. Participants must be able to consent and agree to use birth control until week 28 of the study. Women who are immunocompromised, have concurrent cancer (except nonmelanoma skin lesions), HIV-seropositive, or have active autoimmune diseases cannot join.Inclusion Criteria
I have a confirmed diagnosis of a high-grade cervical precancer.
I weigh at least 110 pounds.
I agree to use birth control until week 28 of the study.
+6 more
Exclusion Criteria
Are you immune compromised in any way?
I have no other cancers except for non-dangerous skin lesions.
I have a diagnosis of early-stage cervical cancer.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive three 5-day cycles of artesunate or placebo vaginal inserts at weeks 0, 2, and 4
6 weeks
3 visits (telehealth)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a LEEP procedure at week 17
40 weeks
3 visits (in-person) at weeks 6, 17, and 40
Participant Groups
The study is testing Artesunate vaginal inserts versus placebo inserts in treating high-grade cervical pre-cancerous lesions caused by HPV. It's a phase II trial where participants are randomly assigned to receive either the treatment or placebo without knowing which one they're getting.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Artesunate vaginal insertExperimental Treatment1 Intervention
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Group II: Placebo vaginal insertsPlacebo Group1 Intervention
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.
Artesunate is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Artesunate for:
- Malaria
- Cervical intraepithelial neoplasia (CIN2/3) - Investigational
🇪🇺 Approved in European Union as Artesunate for:
- Malaria
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic Fairview HospitalCleveland, OH
Florida Gynecologic OncologyFort Myers, FL
Northwell Health Physician Partners Gynecologic OncologyBrightwaters, NY
Grady Health SystemAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Frantz Viral Therapeutics, LLCLead Sponsor
Morehouse School of MedicineCollaborator
Amarex Clinical ResearchCollaborator
Harris Health System (L.B.J. Hospital)Collaborator
The Cleveland ClinicCollaborator
M.D. Anderson Cancer CenterCollaborator
University of MichiganCollaborator
References
Safety and efficacy of topical artesunate for the treatment of vulvar intraepithelial neoplasia 2/3. [2023]To evaluate the safety, tolerability, and efficacy of topical artesunate ointment for treatment of biopsy-confirmed Human papillomavirus (HPV)-associated Vulvar intraepithelial neoplasia (VIN) 2/3.
A first-in-human proof-of-concept trial of intravaginal artesunate to treat cervical intraepithelial neoplasia 2/3 (CIN2/3). [2022]Most treatment options for cervical intraepithelial neoplasia 2/3 (CIN2/3) are either excisional or ablative, and require sequential visits to health care providers. Artesunate, a compound that is WHO-approved for treatment of acute malaria, also has cytotoxic effect on squamous cells transformed by HPV. We conducted a first-in-human Phase I dose-escalation study to assess the safety and efficacy of self-administered artesunate vaginal inserts in biopsy-confirmed CIN2/3.
Four Artemisinin-Based Treatments in African Pregnant Women with Malaria. [2022]Information regarding the safety and efficacy of artemisinin combination treatments for malaria in pregnant women is limited, particularly among women who live in sub-Saharan Africa.
Artemisinin derivatives in the treatment of falciparum malaria in pregnancy. [2019]An artemisinin derivative (artesunate or artemether) was used for the treatment of multidrug-resistant Plasmodium falciparum malaria in 83 Karen pregnant women in Thailand; 55 women were treated for recrudescent infection following quinine or mefloquine, 12 for uncomplicated hyperparasitaemic episodes, and 16 had not declared their pregnancy when treated. The women were followed weekly until delivery. Artesunate and artemether were well tolerated and there was no drug-related adverse effect. Recrudescence within 42 d occurred in 16% of the treated episodes. Overall 73 pregnancies (88%) resulted in live births, 3 (4%) in abortions and 2 (3%) in still births, and 5 women were lost to follow-up before delivery. There was no congenital abnormality in any of the newborn children, and the 46 children followed for more than one year all developed normally.
Four artemisinin-based treatments in African pregnant women with malaria. [2022]Information regarding the safety and efficacy of artemisinin combination treatments for malaria in pregnant women is limited, particularly among women who live in sub-Saharan Africa.
Dinoprostone Vaginal Insert: A Review in Cervical Ripening. [2021]Dinoprostone vaginal insert (Cervidil®; Propess®), a retrievable vaginal pessary containing 10 mg of dinoprostone [prostaglandin E2 (PGE2)] in a controlled-release drug delivery device, is approved in many countries worldwide for the initiation (or continuation) of cervical ripening in patients at term prior to labour induction. The device is designed to provide a constant and sustained release of dinoprostone to the cervix to promote the complex processes involved in cervical ripening. The vaginal insert is attached to a retrieval system that facilitates easy removal of the device at the onset of labour or in the event of complications. The effectiveness of dinoprostone vaginal insert has been demonstrated in a vast range of randomized clinical trials in women at term. The agent is well tolerated, with a generally favourable safety profile, both maternal and foetal/neonatal. As with all prostaglandin agents used in cervical ripening, dinoprostone vaginal insert is associated with a risk of uterine hyperstimulation. However, this is generally rapidly reversible upon removal of the insert. The demonstrated effectiveness and safety of the device, combined with the benefits of controlled drug release from a simple, single application, and efficient dose control, suggest that dinoprostone vaginal insert is a valuable option for promoting cervical ripening in patients with an unfavourable cervix at term.
[Dinoprostone: slow release vaginal insert (Propess) and intracervical gel (Prepidil) for the induction of labour with unriped cervix]. [2013]The purpose of the present study is to compare the effectiveness and safety of a slow release vaginal PGE2 insert (Propess) with intracervical PGE2 gel (Prepidil gel) in the induction of cervical ripening and labour.
A randomized trial of vaginal prostaglandin E2 for induction of labor. Insert vs. tablet. [2013]To compare the efficacy and safety of a prostaglandin E2 (PGE2) vaginal insert with PGE2 administered as a vaginal tablet.
Dinoprostone vaginal insert for cervical ripening and labor induction: a meta-analysis. [2019]To compare dinoprostone 10 mg controlled-release vaginal insert with other forms of vaginal or cervical prostaglandin for cervical ripening.
Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. [2019]Dinoprostone vaginal insert has been compared to Dinoprostone cervical gel in few studies, whose cases presented different Bishop scores and gestational ages at admission, and various treatment strategies in control arms. The present study compares the vaginal insert to the cervical gel in patients with low Bishop score at term.