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NCT Number: NCT03100045

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

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

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate Suppositories

Drug

Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia

Other names: Artemisinin

Primary outcomes

  1. Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3)

    Time frame: 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 outcomes

  1. Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less

    Time frame: 16 weeks

    Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy

  2. Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less

    Time frame: 28 weeks

    Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy

  3. Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping

    Time frame: 40 weeks

    Number of patients with HPV genotypes present at study entry which become undetectable during the study window

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Frantz Viral Therapeutics, LLC
  • University of Wisconsin, Madison

Registry information

Official study title

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

Acronym: ART-AIN

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2017
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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