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Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Anus Neoplasms

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Trial Information

Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Pathologic response (progression, no change, or regression) of anal HSIL to treatment with the topical cream versus treatment with placebo

Outcome Time Frame:

Clinical assessment at screen, week 24, week 48, and follow up at week 60

Safety Issue:

No

Principal Investigator

Misha R Cohen, OMD, LAc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute for Health and Aging, UCSF School of Nursing

Authority:

United States: Food and Drug Administration

Study ID:

CCRC 5031

NCT ID:

NCT00622440

Start Date:

March 2008

Completion Date:

December 2012

Related Keywords:

  • Anus Neoplasms
  • HSIL
  • HGAIN
  • AIN
  • neoplasia
  • dysplasia
  • TCM
  • Traditional Chinese Medicine
  • Anus Neoplasms
  • Neoplasms
  • Uterine Cervical Dysplasia

Name

Location
UCSF Mt. Zion Medical Center, 1600 Divisadero St., Box 1699 San Francisco, California  94143-1699