Anal Cancer, Precancerous Condition
Conditions
Keywords
anal cancer, high-grade squamous intraepithelial lesion
Brief summary
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
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.
Interventions
PROCEDUREinfrared photocoagulation therapy
DEVICEInfrared 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.
Sponsors
National Cancer Institute (NCI)
AIDS Malignancy Consortium
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed