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

Primary Purpose

Anus Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AIJP (Arnebia Indigo Jade Pearl)
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anus Neoplasms focused on measuring HSIL, HGAIN, AIN, neoplasia, dysplasia, TCM, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
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
Percent of recommended applications of cream reported in participant diary. >75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent
Response With >50% Adherence
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
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.

Full Information

First Posted
February 13, 2008
Last Updated
April 14, 2020
Sponsor
University of California, San Francisco
Collaborators
Spring Wind Herbs
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1. Study Identification

Unique Protocol Identification Number
NCT00622440
Brief Title
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
Acronym
AIJP
Official Title
Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 14, 2008 (Actual)
Primary Completion Date
December 12, 2012 (Actual)
Study Completion Date
December 12, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Spring Wind Herbs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anus Neoplasms
Keywords
HSIL, HGAIN, AIN, neoplasia, dysplasia, TCM, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AIJP (Arnebia Indigo Jade Pearl)
Intervention Description
Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo twice daily for 48 weeks.
Primary Outcome Measure Information:
Title
Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
Description
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.
Time Frame
Baseline, Week 48, and Week 60; up to 60 weeks
Secondary Outcome Measure Information:
Title
Treatment Adherence
Description
Percent of recommended applications of cream reported in participant diary. >75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent
Time Frame
Up to 48 weeks
Title
Response With >50% Adherence
Description
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.
Time Frame
Baseline, Week 48, and Week 60; up to 60 weeks
Title
Response With >75% Adherence
Description
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.
Time Frame
Baseline, Week 48, and Week 60; up to 60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misha R Cohen, OMD, LAc
Organizational Affiliation
Chicken Soup Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naomi Jay, PhD, FNP
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.ucsfhealth.org/adult/medical_services/cancer/cr/conditions/anal/signs.html
Description
General information about HPV, dysplasia, and anal cancer. The website also includes a list of providers of high-resolution anoscopy (HRA).

Learn more about this trial

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

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