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

Primary Purpose

HPV-Related Anal Intraepithelial Neoplasia, AIN2/3, Artesunate

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Artesunate Suppositories
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HPV-Related Anal Intraepithelial Neoplasia focused on measuring HPV, suppository, Artesunate, artemisinin, anal dysplasia, treatment, alternative treatment, anal precancer, Johns Hopkins, Sandy Fang, Frantz Viral Therapeutics, Wisconsin, Evie Carchman

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital
  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ART 200 mg, 2 cycles

ART 200 mg, 3 cycles

ART 400 mg, 2 cycles

ART 400 mg, 3 cycles

ART 600 mg, 2 cycles

ART 600 mg, 3 cycles

Arm Description

Two five-day cycles of Artesunate suppositories, 200 mg/day

Three five-day cycles of Artesunate suppositories, 200 mg/day

Two five-day cycles of Artesunate suppositories, 400 mg/day

Three five-day cycles of Artesunate suppositories, 400 mg/day

Two five-day cycles of Artesunate suppositories, 600 mg/day

Three five-day cycles of Artesunate suppositories, 600 mg/day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
March 29, 2017
Last Updated
November 2, 2021
Sponsor
Johns Hopkins University
Collaborators
Frantz Viral Therapeutics, LLC, University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03100045
Brief Title
Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
Acronym
ART-AIN
Official Title
A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
October 6, 2021 (Actual)
Study Completion Date
October 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Frantz Viral Therapeutics, LLC, University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV-Related Anal Intraepithelial Neoplasia, AIN2/3, Artesunate, Alternative Treatment, Anal Dysplasia, Precancerous Conditions, Human Papilloma Virus
Keywords
HPV, suppository, Artesunate, artemisinin, anal dysplasia, treatment, alternative treatment, anal precancer, Johns Hopkins, Sandy Fang, Frantz Viral Therapeutics, Wisconsin, Evie Carchman

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Subjects will be enrolled sequentially in each treatment cohort.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ART 200 mg, 2 cycles
Arm Type
Experimental
Arm Description
Two five-day cycles of Artesunate suppositories, 200 mg/day
Arm Title
ART 200 mg, 3 cycles
Arm Type
Experimental
Arm Description
Three five-day cycles of Artesunate suppositories, 200 mg/day
Arm Title
ART 400 mg, 2 cycles
Arm Type
Experimental
Arm Description
Two five-day cycles of Artesunate suppositories, 400 mg/day
Arm Title
ART 400 mg, 3 cycles
Arm Type
Experimental
Arm Description
Three five-day cycles of Artesunate suppositories, 400 mg/day
Arm Title
ART 600 mg, 2 cycles
Arm Type
Experimental
Arm Description
Two five-day cycles of Artesunate suppositories, 600 mg/day
Arm Title
ART 600 mg, 3 cycles
Arm Type
Experimental
Arm Description
Three five-day cycles of Artesunate suppositories, 600 mg/day
Intervention Type
Drug
Intervention Name(s)
Artesunate Suppositories
Other Intervention Name(s)
Artemisinin
Intervention Description
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3)
Description
Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0
Time Frame
6 weeks from the date of the first dosing
Secondary Outcome Measure Information:
Title
Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less
Description
Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy
Time Frame
16 weeks
Title
Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less
Description
Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy
Time Frame
28 weeks
Title
Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping
Description
Number of patients with HPV genotypes present at study entry which become undetectable during the study window
Time Frame
40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy H Fang, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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