A Phase I Study of Intra-anally Administered Artesunate in Patients with High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this trial is to find a non-surgical way to treat high grade anal dysplasia using Artesunate suppositories. Artesunate is an anti-malarial drug. We will be using different doses of this suppository to try to find out which dose is best. High-grade anal intraepithelial neoplasia (AIN 2/3), also known as high-grade anal dysplasia, are precancerous cells that could become a cancer in the future. Most of the changes that lead to cancer are caused by human papillomavirus or HPV. There is no known cure for HPV at this time. The usual treatment for these precancerous cells is surgery; however, this is not a cure, and these precancerous cells can come back. Following surgery, patients have a lot of pain, and can develop problems with bowel movements if multiple surgeries are needed. Artesunate is widely used by the World Health Organization (WHO) for the treatment of malaria and has been used worldwide for many years in different dosages and forms. Laboratory studies show that it kills cells that are infected with HPV. This is the first study that will look at the potential role of Artesunate in treating high-grade anal dysplasia.
•Age ? 18 years.•Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy•Female of childbearing potential: negative urine pregnancy test.•Adequate contraceptive use for males and females of reproductive potential.•Patients who have the ability to collaborate with planned follow-up (transportation, compliance history, etc.).•Weight ? 50 kg.•Life expectancy greater than 2 years.
Patients who meet the eligibility criteria will be enrolled sequentially in 6 treatment groups receiving 2 or 3 cycles of Artesunate suppositories. Treatment cycles consist of 5 days of Artesunate suppositories administered 2 weeks apart. There will be a follow-up visit 1 week after the start of each treatment cycle to evaluate for any toxicities.
01/17/2020 05:03 AM