Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
RATIONALE: Infrared coagulation may be effective in preventing the development of anal cancer in patients who have anal neoplasia.
PURPOSE: Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia.
|Anal Cancer Precancerous Condition||Procedure: infrared photocoagulation therapy Device: Infrared Coagulator||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study|
|Study Start Date:||September 2003|
|Study Completion Date:||April 2006|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
|Experimental: Infrared coagulator||
Procedure: infrared photocoagulation therapy
Device: Infrared Coagulator
IRC treatment of up to 3 HGAIN lesions at baseline (study initiation). A second IRC treatment may be administered for recurrent lesions at the 3 month visit.
Other Name: Redfield Infrared Coagulator (IRC) 2100
- Determine the recurrence rate of high-grade squamous intraepithelial neoplasia in the anal canal of HIV-positive patients treated with infrared coagulation.
- Determine the time to recurrence and time to progression in patients treated with this procedure.
- Determine the toxicity of this procedure in these patients.
- Correlate CD4/CD8 count and HIV viral load with outcome in patients treated with this procedure.
- Correlate outcome with human papilloma virus subtype in patients treated with this procedure.
OUTLINE: This is an open-label, pilot, multicenter study.
Patients undergo treatment with an infrared coagulator in direct contact with the lesion for 1.5 seconds and necrotic tissue is then debrided. Treatment repeats to the level of the submucosal vessels under colposcopic guidance. A repeat biopsy is performed at 3 months to assess treatment success. Patients with incompletely treated lesions receive 1 more treatment. Up to 3 lesions are treated during each visit in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires regarding anal pain and discomfort at baseline, at 4 weeks, and at 3, 6, 9, and 12 months.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066430
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94143|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Elizabeth Stier, MD||Memorial Sloan Kettering Cancer Center|