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

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Brief Title

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

Official Title

A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults

Brief 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.
    

Detailed Description

      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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Complete Response Through 1 Year

Secondary Outcome

 Tolerability and Safety of Infrared Coagulator Ablation

Condition

Anal Cancer

Intervention

clinical observation

Study Arms / Comparison Groups

 Arm I: Infrared coagulator treatment
Description:  Infrared photocoagulation therapy. The 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

120

Start Date

April 2011

Completion Date

July 2016

Primary Completion Date

July 2015

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
      

Gender

All

Ages

27 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stephen E. Goldstone, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01164722

Organization ID

AMC-076

Secondary IDs

U01CA121947

Responsible Party

Sponsor

Study Sponsor

AIDS Malignancy Consortium

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Stephen E. Goldstone, MD, Principal Investigator, Laser Surgery Care


Verification Date

July 2020