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

NCT03100045 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IRB00090922
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less

  16 weeks

• Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less

  28 weeks

• Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping

  40 weeks

Study Arms (6)

ART 200 mg, 2 cycles

EXPERIMENTAL

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

Drug: Artesunate Suppositories

ART 200 mg, 3 cycles

EXPERIMENTAL

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

Drug: Artesunate Suppositories

ART 400 mg, 2 cycles

EXPERIMENTAL

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

Drug: Artesunate Suppositories

ART 400 mg, 3 cycles

EXPERIMENTAL

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

Drug: Artesunate Suppositories

ART 600 mg, 2 cycles

EXPERIMENTAL

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

Drug: Artesunate Suppositories

ART 600 mg, 3 cycles

EXPERIMENTAL

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

Drug: Artesunate Suppositories

Interventions

Artesunate Suppositories DRUG

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

Also known as: Artemisinin

ART 200 mg, 2 cycles; ART 200 mg, 3 cycles; ART 400 mg, 2 cycles; ART 400 mg, 3 cycles; ART 600 mg, 2 cycles; ART 600 mg, 3 cycles

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Frantz Viral Therapeutics, LLC: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Precancerous Conditions

Interventions

artemisinin

Condition Hierarchy (Ancestors)

Neoplasms

Study Officials

• Sandy H Fang, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be enrolled sequentially in each treatment cohort.

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: April 20, 2017
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)