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

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ClinicalTrials.gov Identifier: NCT03100045
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : April 12, 2021
Sponsor:
Collaborators:
Frantz Viral Therapeutics, LLC
University of Wisconsin, Madison
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease Intervention/treatment Phase
HPV-Related Anal Intraepithelial Neoplasia AIN2/3 Artesunate Alternative Treatment Anal Dysplasia Precancerous Conditions Human Papilloma Virus Drug: Artesunate Suppositories Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Subjects will be enrolled sequentially in each treatment cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Artemisinin




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100045


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Johns Hopkins University
Frantz Viral Therapeutics, LLC
University of Wisconsin, Madison
Investigators
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Principal Investigator: Sandy H Fang, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03100045    
Other Study ID Numbers: IRB00090922
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
HPV
suppository
Artesunate
artemisinin
anal dysplasia
treatment
alternative treatment
anal precancer
Johns Hopkins
Sandy Fang
Frantz Viral Therapeutics
Wisconsin
Evie Carchman
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Papilloma
Precancerous Conditions
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Artesunate
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics