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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03100045
Other study ID # IRB00090922
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 20, 2017
Est. completion date October 6, 2021

Study information

Verified date November 2021
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 6, 2021
Est. primary completion date October 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University Frantz Viral Therapeutics, LLC, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 weeks from the date of the first dosing
Secondary 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 16 weeks
Secondary 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 28 weeks
Secondary 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 40 weeks
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