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Trial record 2 of 8 for:    artemisinin | cancer

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

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date April 12, 2021
Actual Study Start Date  ICMJE April 20, 2017
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • Regression of anal intraepithelial neoplasia (AIN2/3) to Anal Intraepithelial Neoplasia (AIN1) or less [ Time Frame: 16 weeks ]
    Clearance of AIN2/3 disease
  • Clearance of human papillomavirus (HPV) virus measured by HPV genotyping [ Time Frame: 40 weeks ]
    Clearance of HPV virus in anal specimens collected sequentially
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
Official Title  ICMJE A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • HPV-Related Anal Intraepithelial Neoplasia
  • AIN2/3
  • Artesunate
  • Alternative Treatment
  • Anal Dysplasia
  • Precancerous Conditions
  • Human Papilloma Virus
Intervention  ICMJE Drug: Artesunate Suppositories
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Other Name: Artemisinin
Study Arms  ICMJE
  • Experimental: ART 200 mg, 2 cycles
    Two five-day cycles of Artesunate suppositories, 200 mg/day
    Intervention: Drug: Artesunate Suppositories
  • Experimental: ART 200 mg, 3 cycles
    Three five-day cycles of Artesunate suppositories, 200 mg/day
    Intervention: Drug: Artesunate Suppositories
  • Experimental: ART 400 mg, 2 cycles
    Two five-day cycles of Artesunate suppositories, 400 mg/day
    Intervention: Drug: Artesunate Suppositories
  • Experimental: ART 400 mg, 3 cycles
    Three five-day cycles of Artesunate suppositories, 400 mg/day
    Intervention: Drug: Artesunate Suppositories
  • Experimental: ART 600 mg, 2 cycles
    Two five-day cycles of Artesunate suppositories, 600 mg/day
    Intervention: Drug: Artesunate Suppositories
  • Experimental: ART 600 mg, 3 cycles
    Three five-day cycles of Artesunate suppositories, 600 mg/day
    Intervention: Drug: Artesunate Suppositories
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03100045
Other Study ID Numbers  ICMJE IRB00090922
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Frantz Viral Therapeutics, LLC
  • University of Wisconsin, Madison
Investigators  ICMJE
Principal Investigator: Sandy H Fang, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP