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

November 2, 2021 updated by: Johns Hopkins University

A Phase I Study of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ART 200 mg, 2 cycles
Two five-day cycles of Artesunate suppositories, 200 mg/day
Drug: Artesunate Suppositories
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Other Names:
  • Artemisinin
Experimental: ART 200 mg, 3 cycles
Three five-day cycles of Artesunate suppositories, 200 mg/day
Drug: Artesunate Suppositories
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Other Names:
  • Artemisinin
Experimental: ART 400 mg, 2 cycles
Two five-day cycles of Artesunate suppositories, 400 mg/day
Drug: Artesunate Suppositories
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Other Names:
  • Artemisinin
Experimental: ART 400 mg, 3 cycles
Three five-day cycles of Artesunate suppositories, 400 mg/day
Drug: Artesunate Suppositories
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Other Names:
  • Artemisinin
Experimental: ART 600 mg, 2 cycles
Two five-day cycles of Artesunate suppositories, 600 mg/day
Drug: Artesunate Suppositories
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Other Names:
  • Artemisinin
Experimental: ART 600 mg, 3 cycles
Three five-day cycles of Artesunate suppositories, 600 mg/day
Drug: Artesunate Suppositories
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Other Names:
  • Artemisinin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks from the date of the first dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16 weeks
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
28 weeks
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
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of Wisconsin, Madison
Frantz Viral Therapeutics, LLC

Investigators

  • Principal Investigator: Sandy H Fang, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Actual)

October 6, 2021

Study Completion (Actual)

October 6, 2021

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00090922

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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