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Protocol No. UW18118

Principal Investigator Carchman, Evie

Phase I (Cancer Prevention)

Age Group Adult

Scope National

Sponsor Type Industry; Institutional

Title A Phase I Study of Intra-anally Administered Artesunate in Patients with High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

Objective This research is being done to find better ways to treat high grade anal dysplasia. In this study, we will be testing Artesunate, an anti-malarial drug, in the form of anal suppositories in people with high grade anal dysplasia. We will be using different doses of this suppository to try to find out which dose is best. You have been diagnosed with high-grade anal intraepithelial neoplasia (AIN 2/3; also known as high- grade anal dysplasia), which are precancerous cells that may or may not become a cancer in the future. Most of the changes that lead to cancer are caused by human papillomavirus or HPV. Unfortunately, there is no known cure for HPV at this time. We usually treat these precancerous cells with surgery; however, this is not a cure, and these precancerous cells can come back. If you have surgery, you will have pain, and you can develop problems with bowel movements if you have many surgery treatments

Treatment Artesunate suppositories will be administered transanally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. 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

Description Phase I Study of Artesunate in Patients with High-Grade Anal Intraepithelial Neoplasia

Key Eligibility Inclusion criteria:
  • Age greater than or equal to 18 years
  • Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by HRA. This includes patients who are newly diagnosed with AIN 2/3 as well as those who have recurrent AIN 2/3 after medical therapy or surgical therapy
  • Adequate contraceptive use for males and females of reproductive potential
  • 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.)
  • Patients who have and have not been immunized with the HPV vaccine
  • Weight greater than or equal to 50 kg
    Exclusion criteria:
  • Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by HRA
  • Known anal, vulvar, cervical, or penile cancer
  • CD4 count < 200 at the time of consideration for entry into this study. Patients, whose CD4 counts drop below 200 at any timepoint in this study will be treated with the standard of care treatment arm of surgical ablation
  • 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
  • Pregnant female

  • Applicable Disease Sites Anal

    Status Open

    Participating Institutions UW Hospital and Clinics