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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01164722
First received: July 16, 2010
Last updated: July 8, 2014
Last verified: July 2014

July 16, 2010
July 8, 2014
April 2011
July 2015   (final data collection date for primary outcome measure)
Complete response at 3 months and 1 year [ Time Frame: 3 months and 1 year post treatment ] [ Designated as safety issue: No ]
Complete response at 3 months and 1 year [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01164722 on ClinicalTrials.gov Archive Site
  • Tolerability and safety of infrared coagulator ablation [ Time Frame: All study visits through year 2 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with high-grade anal intraepithelial neoplasia at 1 year [ Time Frame: 1 year on study ] [ Designated as safety issue: No ]
  • Recurrence rate at 1 year [ Time Frame: 1 year on study ] [ Designated as safety issue: No ]
  • Incidence of metachronous lesions [ Time Frame: every 3 months on study ] [ Designated as safety issue: No ]
  • Tolerability and safety of IRC ablation [ Designated as safety issue: Yes ]
  • Proportion of patients with HGAIN at 1 year [ Designated as safety issue: No ]
  • Recurrence rate at 1 year [ Designated as safety issue: No ]
  • Incidence of metachronous lesions [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults

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.

OBJECTIVES:

Primary

  • Evaluate the complete response rate at 3 months and 1 year in HIV-seropositive patients with high-grade anal intraepithelial neoplasia (HGAIN) treated with infrared coagulator (IRC) ablation versus observation.

Secondary

  • Determine the tolerability and safety of IRC ablation versus observation in these patients.
  • Compare the proportion of patients with HGAIN at 1 year.
  • Evaluate the response and recurrence rates at 1 year of individual lesions in patients treated with this regimen vs observation.
  • Determine the incidence of metachronous lesions in these patients.
  • Compare the response and recurrence rates at 2 years of individual lesions in patients under observation who subsequently received IRC ablation with the response and recurrence rates at 1 year in patients initially treated with IRC.

OUTLINE: This is a multicenter study. Patients are stratified according to site. Patients are randomized to 1 of 2 arms.

  • Arm I: Infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance for 1.5 seconds. IRC ablation is reapplied until the level of submucosal vessels are reached.

    • One week after each IRC ablation, patients complete a questionnaire regarding pain, bleeding, and other complaints.
  • Arm II: Patients receive standard of care and undergo observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions.

NOTE: Patients may receive a maximum of 6 IRC treatments while on study (3 per year).

Patients undergo a physical exam, digital rectal exam, anal cytology, and HRA at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 2 years.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Anal Cancer
  • Neoplasm of Uncertain Malignant Potential
  • Nonneoplastic Condition
  • Precancerous Condition
  • Other: clinical observation
    Patients undergo observation
  • Procedure: infrared photocoagulation therapy
    Anal infrared coagulator ablation
  • Experimental: Arm I
    Infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
    Intervention: Procedure: infrared photocoagulation therapy
  • Active Comparator: Arm II
    Patients receive standard of care and undergo observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
    Intervention: Other: clinical observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
July 2016
July 2015   (final data collection date for primary outcome measure)

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
Both
27 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01164722
AMC-076, U01CA121947, AMC-076
Yes
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Principal Investigator: Stephen E. Goldstone, MD Laser Surgery Care
AIDS Malignancy Clinical Trials Consortium
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP