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

NCT ID: NCT03100045

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2021-10-06

Brief Summary

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

Detailed Description

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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.

Conditions

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HPV-Related Anal Intraepithelial Neoplasia AIN2/3 Artesunate Alternative Treatment Anal Dysplasia Precancerous Conditions Human Papilloma Virus

Keywords

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HPV suppository Artesunate artemisinin anal dysplasia treatment alternative treatment anal precancer Johns Hopkins Sandy Fang Frantz Viral Therapeutics Wisconsin Evie Carchman

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Subjects will be enrolled sequentially in each treatment cohort.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ART 200 mg, 2 cycles

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

Group Type EXPERIMENTAL

Artesunate Suppositories

Intervention Type DRUG

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

ART 200 mg, 3 cycles

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

Group Type EXPERIMENTAL

Artesunate Suppositories

Intervention Type DRUG

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

ART 400 mg, 2 cycles

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

Group Type EXPERIMENTAL

Artesunate Suppositories

Intervention Type DRUG

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

ART 400 mg, 3 cycles

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

Group Type EXPERIMENTAL

Artesunate Suppositories

Intervention Type DRUG

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

ART 600 mg, 2 cycles

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

Group Type EXPERIMENTAL

Artesunate Suppositories

Intervention Type DRUG

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

ART 600 mg, 3 cycles

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

Group Type EXPERIMENTAL

Artesunate Suppositories

Intervention Type DRUG

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

Interventions

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Artesunate Suppositories

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

Intervention Type DRUG

Other Intervention Names

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Artemisinin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frantz Viral Therapeutics, LLC

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandy H Fang, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00090922

Identifier Type: -

Identifier Source: org_study_id