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

Sponsored by AIDS Malignancy Clinical Trials Consortium

Phase Quota
Phase 3

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.

Study Start Date: April 2011

Estimated Completion Date: July 2016

Specialties: Infectious Disease: HIV/Immunodeficiency Gastroenterology: GI Oncology Oncology: GI Oncology

Interventions

  • Procedure: infrared photocoagulation therapy
  • Other: clinical observation

Inclusion 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

Exclusion criteria

Study Locations And Contact Information

  • Benaroya Research Institute at Virginia Mason Medical Center, Seattle Washington
  • University of Pittsburgh Medical Center, Pittsburgh Pennsylvania
  • Laser Surgery Care, New York New York
  • Boston University Cancer Research Center, Boston Massachusetts
  • New York Weill Cornell Cancer Center at Cornell University, New York New York
  • UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco California
  • UCLA Clinical AIDS Research and Education CARE Center, Los Angeles California

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