Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream

• Status: Completed
• Trial end date: 2012-12-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Spring Wind Herbs

Criteria

Inclusion Criteria:

• Anal HSIL confirmed by biopsy no more than 30 days prior to entry

• Anal HSIL deemed not amenable to therapy or participant declines routine ablative therapy

• HIV positive

• Stable HIV treatment regimen for at least 8 weeks prior to entry

• At least 18 years of age

• Women of childbearing potential must use contraception

• Platelet count above 70,000/mm3 within 30 days prior to entry

• ANC greater or equal to 1000/mm3 within 30 days prior to entry

• Creatinine less then or equal to 1.5 times ULN within 30 days prior to entry

• AST and ALT less than or equal to 3 times ULN within 30 days prior to entry

Exclusion Criteria:

• Prior history of invasive anal, cervical, vaginal, or vulvar cancer

• Pregnancy or lactation and breast-feeding

• Must not participate in a conception process including sperm donation

• Medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with ability to comply with protocol

• Known allergy to any topical cream components

• Patients with lesions clinically suspicious per HRA examiner for early progression (less than one year) to anal cancer