Last updated on December 2016

Topical or Ablative Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Squamous Intraepithelial Lesions


Brief description of study

This randomized phase III trial compares topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer. It is not yet known if treating HSIL is more effective than active monitoring in preventing patients from developing anal cancer.

Detailed Study Description

PRIMARY OBJECTIVES: I. To determine the effectiveness of treating anal HSIL to reduce the incidence of anal cancer in human immunodeficiency virus (HIV)-infected men and women. SECONDARY OBJECTIVES: I. Determine safety of infrared coagulation, electrocautery, imiquimod, 85% trichloroacetic acid and 5-fluorouracil (fluorouracil) treatments for anal HSIL. II. Compare quality of life measures between arms. TERTIARY OBJECTIVES: I. Determine the human papilloma virus (HPV) type in cancer and compare to that of overlying HSIL and HSIL biopsies collected concurrently that did not progress to cancer. II. Determine the strain variant of HPV 16 in participants who progressed to anal cancer and compare to participants with HSIL biopsies who did not progress to cancer. III. Determine the HPV integration site in overlying anal cancer to that of HSIL overlying the cancer and HSIL biopsies collected concurrently that did not progress to cancer. IV. Perform gene expression array analysis comparing expression in anal cancer with HSIL overlying the cancer; perform gene expression array analysis comparing expression in HSIL biopsies that progressed to cancer with non-progressing HSIL biopsies at other locations; perform similar analyses comparing expression in HSIL biopsies that progressed to cancer with the same lesion at earlier time points prior to progression. V. Characterize genetic changes in anal cancers compared with HSIL overlying the cancer; characterize genetic changes in HSIL biopsies that progressed to cancer compared with non-progressing HSIL biopsies at other locations; characterize genetic changes HSIL biopsies that progressed to cancer with the same lesion at earlier time points prior to progression. VI. Identify host and viral biomarkers of progression from HSIL to cancer. VII. Evaluate medical history and behavioral risk factors for HSIL progression to cancer. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients are directed to receive either topical or ablative treatment at the discretion of the clinician. Patients receiving topical treatment apply imiquimod intra-anally, peri-anally or both thrice weekly for up to 16 weeks, fluorouracil twice daily for 5 days every 2 weeks for up to 16 weeks, or trichloroacetic acid every 3 weeks up to 12 weeks. Patients receiving ablative treatment using infrared coagulation, hyfrecation/electrocautery, or laser. Patients may undergo excision under anesthesia if the clinician believes none of the other treatment approaches will be effective. The number and timing of such treatments will be at the discretion of the investigator. Patients with persistent HSIL should continue a protocol-approved treatment or a new protocol treatment should be considered. ARM II: Patients undergo active monitoring with examinations every 6 months. Every 12 months, patients undergo biopsies of visible lesions. Patients have cytology performed at every visit. After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Clinical Study Identifier: NCT02135419

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Ronald Mitsuyasu, MD

UCLA CARE Clinic
Los Angeles, CA United States
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Joel Palefsky, MD

University of California at San Francisco Anal Dysplasia Clinic
San Francisco, CA United States
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Edward Gardener, MD

Denver Public Health
Denver, CO United States
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Jessica Korman, MD

Capital Digestive Care
Washington, WA United States
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Benjamin Stearn, MD

Dupont Circle Physicians Group
Washington, WA United States
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Isabella Rosa-Cunha, MD

University of Miami Miller School of Medicine - Sylvester Cancer Center
Miami, FL United States
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Isabella Rosa-Cunha, MD

University of Miami Miller School of Medicine
Miami, FL United States
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Gary Bucher, MD

Anal Dysplasia Clinic MidWest
Chicago, IL United States
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Elizabeth Stier, MD

Boston Medical Center
Boston, MA United States
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Lori Panther, MD

Fenway Health
Boston, MA United States
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Mark Einstein, MD, MS

Hutchinson Metro Center Ambulatory Care Center
Bronx, NY United States
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Mark Einstein, MD, MS

Montefiore - Albert Einstein College of Medicine
Bronx, NY United States
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Timothy Wilkin, MD, MPH

Cornell Clinical Trials Unit, Chelsea Center
New York, NY United States
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Stephen Goldstone, MD

Laser Surgery Care
New York, NY United States
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Luis Barroso, MD

Wake Forest Baptist Health
Winston-Salem, NC United States
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David Aboulafia, MD

Virginia Mason Medical Center
Seattle, WA United States
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Robert Harrington

Harborview Medical Center
Seattle, WA United States
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Juan De La Ossa, MD

The Polyclinic
Seattle, WA United States
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Maribel Tirado-Gomez, MD

University of Puerto Rico
San Juan, Puerto Rico
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