Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia (NCT00066430) | Clinical Trial Compass
CompletedPhase 1
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
United States18 participantsStarted 2003-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inf…