AIN2/3, Alternative Treatment, Anal Dysplasia, Artesunate, HPV-Related Anal Intraepithelial Neoplasia, Human Papilloma Virus, Precancerous Conditions
Conditions
Keywords
HPV, suppository, Artesunate, artemisinin, anal dysplasia, treatment, alternative treatment, anal precancer, Johns Hopkins, Sandy Fang, Frantz Viral Therapeutics, Wisconsin, Evie Carchman
Brief summary
This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
Detailed description
Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving different doses of Artesunate suppositories administered trans-anally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1 cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.
Interventions
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Sponsors
Frantz Viral Therapeutics, LLC
University of Wisconsin, Madison
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be enrolled sequentially in each treatment cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy (HRA) * Female of childbearing potential: negative urine pregnancy test * Able to provide informed consent * Patients who have the ability to collaborate with planned follow-up (transportation, compliance history, etc.). * Weight ≥50 kg.
Exclusion criteria
* Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by high resolution anoscopy * Known anal, vulvar, cervical, or penile cancer * CD4 count \< 200 at the time of consideration for entry into this study * Unable to provide informed consent * Currently receiving systemic chemotherapy or radiation therapy for another cancer. * Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease) * Extensive anal condyloma precludes the ability for the clinician to visualize HSIL during HRA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3) | 6 weeks from the date of the first dosing | Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less | 16 weeks | Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy |
| Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping | 40 weeks | Number of patients with HPV genotypes present at study entry which become undetectable during the study window |
Countries
United States
Outcome results
None listed