Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

Human Papilloma Virus Clinical Trial

— ART-AIN  

Official title:

A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100045
• Other study ID #: IRB00090922
• Status: Completed
• Phase: Phase 1
• Start date: April 20, 2017
• Est. completion date: October 6, 2021

Study information

• Verified date: November 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• AIN2/3
• Alternative Treatment
• Anal Dysplasia
• Artesunate
• Carcinoma in Situ
• HPV-Related Anal Intraepithelial Neoplasia
• Human Papilloma Virus
• Neoplasms
• Papilloma
• Precancerous Conditions

Intervention

Drug:
• Artesunate Suppositories
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Frantz Viral Therapeutics, LLC, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3)	Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0	6 weeks from the date of the first dosing
Secondary	Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less	Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy	16 weeks
Secondary	Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less	Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy	28 weeks
Secondary	Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping	Number of patients with HPV genotypes present at study entry which become undetectable during the study window	40 weeks