Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia

This is an interventional prevention trial for Anal Cancer focused on measuring anal cancer, HIV infection, human papilloma virus infection, neoplasm of uncertain malignant potential, high-grade squamous intraepithelial lesion Read More

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