Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
Condition: Anal Cancer; Neoplasm of Uncertain Malignant Potential; Nonneoplastic Condition; Precancerous Condition
MeSH terms: Anus Neoplasms; Precancerous Conditions; Disease
Intervention: clinical observation; infrared photocoagulation therapy
Intervention description: Patients undergo observation; Anal infrared coagulator ablation
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 27 Years
Healthy volunteers: No
Keywords: anal cancer; HIV infection; human papilloma virus infection; neoplasm of uncertain malignant potential; high-grade squamous intraepithelial lesion

Summary:

      RATIONALE: Infrared coagulator ablation may be effective in preventing the development of
      anal cancer in patients with anal neoplasia

      PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how
      well it works compared to observation in preventing anal cancer in HIV-positive patients with
      anal neoplasia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of high-grade anal intraepithelial neoplasia (AIN) meeting the following:

               -  AIN2 and/or AIN3 confirmed by biopsy ≥ 2 weeks to ≤ 60 days before enrollment

               -  1-3 lesions with each lesion ≤ 15 mm in diameter

               -  At least one high-grade AIN lesion is still visible at study entry

          -  HIV-infection documented by federally approved, licensed HIV-test in conjunction with
             screening test (e.g., ELISA, western blot, or other test)

               -  HIV-infection, based on prior ELISA and western blot assays, recorded and
                  documented by another physician, allowed provided patient undergoes an approved
                  antibody test to confirm diagnosis

               -  Patients on concurrent anti-retroviral therapy with a history of HIV-positivity
                  based on an approved antibody test allowed

               -  Detectable plasma HIV-1 RNA also allowed

          -  No perianal AIN, perianal condyloma, or lower vulvar intraepithelial neoplasia or
             condyloma requiring treatment

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  Life expectancy ≥ 2 years

          -  CD4 count ≥ 200/mm³

          -  ANC > 750/mm³

          -  Platelet count ≥ 75,000/mm³

          -  Hemoglobin ≥ 9.0 g/dL

          -  INR and aPTT normal

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Female patients must have undergone cervical pap smear (if having a cervix) and
             gynecologic evaluation within the past 12 months

          -  Must be capable of complying with the requirements of this protocol

          -  Concurrent HPV-related disease allowed

          -  No history of anal cancer

          -  No acute infection or other serious medical illness requiring treatment within the
             past 14 days

               -  Fungal infection of the skin or a sexually transmitted disease requiring
                  treatment allowed

          -  No concurrent malignancy requiring systemic therapy

               -  Kaposi sarcoma limited to the skin allowed

        PRIOR CONCURRENT THERAPY:

          -  No prior infrared coagulator (IRC) ablation for high-grade anal intraepithelial
             neoplasia (HGAIN)

               -  Prior HGAIN treated by any means other than IRC within the past 2 months allowed

          -  At least 5 days since prior coumadin or clopidogrel and ≥ 7 days after study therapy
             before receiving coumadin or clopidogrel again

          -  No concurrent anticoagulant therapy other than aspirin or NSAIDs

          -  More than 3 months since prior and concurrent systemic corticosteroids, cytokines, or
             immunomodulatory therapy (e.g., interferons) or local imiquimod

          -  No concurrent systemic therapy