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

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 2

Conditions

Anus Neoplasms

Treatments

Drug: AIJP (Arnebia Indigo Jade Pearl)

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00622440

NCI-2011-03238 (Registry Identifier)

07501

P-07-020 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full description

The purpose of this study is to test a new noninvasive topical cream, AIJP (Arnebia Indigo Jade Pearl), for treatment of precancerous anal lesions in order to prevent their progression to anal cancer. AIJP is a topical Chinese herbal cream that has been specifically designed to treat people with the cancer precursor lesions caused by human papillomavirus (HPV). In general, HPV infection is a key factor in development of cervical, anal and vulvar cancers. People with HIV are especially vulnerable to develop anal cancer associated with HPV. It is known that prior to development of anal cancer a person develops a precancerous condition known as a high-grade squamous intraepithelial lesion (HSIL). Treatment of the HSIL can prevent progression to anal cancer. Current therapies for HSIL and anal cancer are highly invasive. A new effective noninvasive topical therapy for precancerous HSIL could have a high impact on prevention of anal cancer.

Enrollment

70 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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