- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00622440
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream (AIJP)
Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
Placebo twice daily for 48 weeks.
|
Active Comparator: 1
|
Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
Time Frame: Baseline, Week 48, and Week 60; up to 60 weeks
|
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. |
Baseline, Week 48, and Week 60; up to 60 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Adherence
Time Frame: Up to 48 weeks
|
Percent of recommended applications of cream reported in participant diary. >75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent |
Up to 48 weeks
|
Response With >50% Adherence
Time Frame: Baseline, Week 48, and Week 60; up to 60 weeks
|
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. |
Baseline, Week 48, and Week 60; up to 60 weeks
|
Response With >75% Adherence
Time Frame: Baseline, Week 48, and Week 60; up to 60 weeks
|
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. |
Baseline, Week 48, and Week 60; up to 60 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Misha R Cohen, OMD, LAc, Chicken Soup Chinese Medicine
- Principal Investigator: Naomi Jay, PhD, FNP, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07501
- P-07-020 (Other Grant/Funding Number: Cancer Treatment Research Foundation (CTRF))
- NCI-2011-03238 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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