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

Johns Hopkins University

Status and phase: Completed; Phase 1

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

Treatments: Drug: Artesunate Suppositories

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03100045

IRB00090922

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

ART 200 mg, 2 cycles

Experimental group

Description:

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

Treatment:

Drug: Artesunate Suppositories

ART 200 mg, 3 cycles

Experimental group

Description:

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

Treatment:

Drug: Artesunate Suppositories

ART 400 mg, 2 cycles

Experimental group

Description:

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

Treatment:

Drug: Artesunate Suppositories

ART 400 mg, 3 cycles

Experimental group

Description:

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

Treatment:

Drug: Artesunate Suppositories

ART 600 mg, 2 cycles

Experimental group

Description:

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

Treatment:

Drug: Artesunate Suppositories

ART 600 mg, 3 cycles

Experimental group

Description:

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

Treatment:

Drug: Artesunate Suppositories