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

Johns Hopkins University18 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Artesunate SuppositoriesDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

Time frame: 6 weeks from the date of the first dosing

Secondary Outcomes

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

Time frame: 16 weeks

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

Time frame: 28 weeks

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

Time frame: 40 weeks

Data from ClinicalTrials.gov

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