Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study

Conditions
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Anal Cancer, Precancerous Condition

Intervention / Treatment
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* Procedure: infrared photocoagulation therapy
* Device: Infrared Coagulator


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: HIV positive Presence of internal anal lesions with histologically confirmed high-grade squamous intraepithelial neoplasia with at least 1 positive margin No more than 3 lesions, each no more than 10 mm in diameter No evidence of microscopic invasion in any anal biopsy specimens No history of anal cancer PATIENT CHARACTERISTICS: Age Over 18 Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Platelet count at least 50,000/mm^3 CD4 count at least 50 cells/mm^3 Hepatic Not specified Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No allergy to lidocaine No anal insertions, including enemas or anal intercourse, for 24 hours before and at least 1 week after study treatment No prior severe photosensitivity reaction No active opportunistic infection No concurrent neoplasia requiring cytotoxic therapy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Must be on stable regimen of highly active antiretroviral therapy (HAART) for at least 12 weeks prior to study entry unless CD4 count > 200/mm^3 AND no plans to initiate HAART within the next 3 months More than 14 days since prior acute treatment for an infection or other medical illness No prior infrared coagulation for anal dysplasia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infrared coagulator<br> | Procedure: infrared photocoagulation therapy<br> <br> Device: Infrared Coagulator<br>* 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.<br>* Other names: Redfield Infrared Coagulator (IRC) 2100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal cancer, high-grade squamous intraepithelial lesion