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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00622440
First received: February 13, 2008
Last updated: August 11, 2014
Last verified: August 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) [ Time Frame: Baseline/screen, Week 48, Week 60 ] [ Designated as safety issue: No ]

    Response assessed 12 weeks after treatment.

    Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60.

    Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)

    Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)

    No Response (NR): HSIL present at weeks 48 & 60 on histology, or improvement ≤ 50% in number, size, area or characteristics.



Secondary Outcome Measures:
  • Treatment Adherence [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

    Percent of recommended applications of cream reported in participant diary.

    >75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent


  • Estimate Effect Size for Phase 3 Trial [ Time Frame: Baseline, Week 60 ] [ Designated as safety issue: No ]
    Secondary outcome stated in original protocol posting

  • Response With >50% Adherence [ Time Frame: Baseline, 48 weeks, 60 weeks ] [ Designated as safety issue: No ]

    Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.

    Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree HSIL absent at week 60.

    Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs reviewed by two clinicians, with decision by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)

    Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in number of lesions with HSIL, or improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved)

    No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics.


  • Response With >75% Adherence [ Time Frame: Baseline, 48 weeks, 60 weeks ] [ Designated as safety issue: No ]

    Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.

    Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60.

    Complete response (CR): No HSIL on histology or cytology (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)

    Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)

    No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics.



Enrollment: 70
Study Start Date: March 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: AIJP (Arnebia Indigo Jade Pearl)
Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCSF Mt. Zion Medical Center, 1600 Divisadero St., Box 1699
San Francisco, California, United States, 94143-1699
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:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00622440     History of Changes
Other Study ID Numbers: CCRC 5031, CC # 07501, CTRF Grant # P-07-020
Study First Received: February 13, 2008
Results First Received: July 17, 2014
Last Updated: August 11, 2014
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

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 16, 2014