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

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00622440

Purpose

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).

Condition	Intervention	Phase
Anus Neoplasms	Drug: AIJP (Arnebia Indigo Jade Pearl) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream

Resource links provided by NLM:

MedlinePlus related topics: Anal Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Pathologic response (progression, no change, or regression) of anal HSIL to treatment with the topical cream versus treatment with placebo [ Time Frame: Clinical assessment at screen, week 24, week 48, and follow up at week 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate treatment adherence and drop-out rates, and obtain effect size for Phase 3 trial [ Time Frame: Week 24, week 48, and week 60 ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: AIJP (Arnebia Indigo Jade Pearl) Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
2: Placebo Comparator	Drug: Placebo Placebo twice daily for 48 weeks.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622440

Contacts

Contact: Fred Fishman, BS	(415) 353-7443	Fred.Fishman@ucsf.edu
Contact: Naomi Jay, Ph.D., FNP	(415) 353-7443	Naomi.Jay@ucsf.edu

Locations

United States, California
UCSF Mt. Zion Medical Center, 1600 Divisadero St., Box 1699	Recruiting
San Francisco, California, United States, 94143-1699
Contact: Fred Fishman 415-353-7443 Fred.Fishman@ucsf.edu
Contact: Naomi Jay, PhD (415) 353-7443 Naomi.Jay@ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Misha R Cohen, OMD, LAc

Institute for Health and Aging, UCSF School of Nursing

More Information

Additional Information:

General information about HPV, dysplasia, and anal cancer. The website also includes a list of providers of high-resolution anoscopy (HRA). This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Institute for Health and Aging, UCSF School of Nursing ( Misha Cohen, O.M.D., L.Ac. )
Study ID Numbers:	CCRC 5031, CC # 07501, CTRF Grant # P-07-020
Study First Received:	February 13, 2008
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00622440 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

HSIL
HGAIN
AIN
neoplasia

dysplasia
TCM
Traditional Chinese Medicine

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Rectal Neoplasm
Intestinal Diseases
Anal Cancer
Rectal Diseases

Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Anus Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Neoplasms

Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Anus Neoplasms
Anus Diseases
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009