Clinical trial NCT00622440: Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
Official title: Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anus Neoplasms
Keywords: HSIL
HGAIN
AIN
neoplasia
dysplasia
TCM
Traditional Chinese Medicine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Spring Wind Herbs
First posted: 2008-02-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
timeFrame: Baseline, Week 48, and Week 60; up to 60 weeks
Secondary outcomes:
measure: Treatment Adherence
timeFrame: Up to 48 weeks
measure: Response With >50% Adherence
timeFrame: Baseline, Week 48, and Week 60; up to 60 weeks
measure: Response With >75% Adherence
timeFrame: Baseline, Week 48, and Week 60; up to 60 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Chicken Soup Chinese Medicine
name: Misha R Cohen, OMD, LAc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Naomi Jay, PhD, FNP
role: PRINCIPAL_INVESTIGATOR
References: