Clinical trial NCT04098744: Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Official title: A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: CIN 2/3
HPV Infection
Pre-Cancerous Dysplasia
Cervical Dysplasia
HPV Related Disease
Keywords: treatment study
cancer prevention
non-surgical
HPV related disease
CIN
topical treatment
vaginal inserts
artesunate
artemisinin
non-invasive
high risk HPV
vaginal suppository
Lead sponsor: Frantz Viral Therapeutics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Amarex Clinical Research
name: M.D. Anderson Cancer Center
name: Harris Health System (L.B.J. Hospital)
name: The Cleveland Clinic
name: University of Michigan
name: Morehouse School of Medicine
First posted: 2019-09-23
Enrollment: 78
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Proportion of participants with histologic regression by week 17
timeFrame: 17 weeks
Secondary outcomes:
measure: Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17
timeFrame: 17 weeks
measure: Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure.
timeFrame: 40 weeks
Other outcomes:
measure: Number of participants with Treatment-Emergent Adverse Events (TEAE)
timeFrame: 6 weeks
measure: Number of participants who withdrew from the study due to TEAEs
timeFrame: 6 weeks
Locations:
city: Fort Myers
country: United States
facility: Florida Gynecologic Oncology
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital
state: Ohio
city: Houston
country: United States
facility: The Harris Health System (L.B.J Hospital)
state: Texas
city: Houston
country: United States
facility: University of Texas, M.D. Anderson
state: Texas
Study officials:
References: