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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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 evidence of microscopic invasion in any anal biopsy specimens
No history of anal cancer
PATIENT CHARACTERISTICS:
Age
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Hematopoietic
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PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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