Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia

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Brief Title

Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia

Official Title

Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study

Brief Summary

      RATIONALE: Infrared coagulation may be effective in preventing the development of anal cancer
      in patients who have anal neoplasia.

      PURPOSE: Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal
      cancer in HIV-positive patients who have high-grade anal neoplasia.

Detailed Description


        -  Determine the recurrence rate of high-grade squamous intraepithelial neoplasia in the
           anal canal of HIV-positive patients treated with infrared coagulation.

        -  Determine the time to recurrence and time to progression in patients treated with this

        -  Determine the toxicity of this procedure in these patients.

        -  Correlate CD4/CD8 count and HIV viral load with outcome in patients treated with this

        -  Correlate outcome with human papilloma virus subtype in patients treated with this

      OUTLINE: This is an open-label, pilot, multicenter study.

      Patients undergo treatment with an infrared coagulator in direct contact with the lesion for
      1.5 seconds and necrotic tissue is then debrided. Treatment repeats to the level of the
      submucosal vessels under colposcopic guidance. A repeat biopsy is performed at 3 months to
      assess treatment success. Patients with incompletely treated lesions receive 1 more
      treatment. Up to 3 lesions are treated during each visit in the absence of disease
      progression or unacceptable toxicity.

      Patients complete questionnaires regarding anal pain and discomfort at baseline, at 4 weeks,
      and at 3, 6, 9, and 12 months.

      Patients are followed every 3 months for 1 year.

      PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 6 months.

Study Phase

Phase 1

Study Type



Anal Cancer


infrared photocoagulation therapy

Study Arms / Comparison Groups

 Infrared coagulator


* 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


Estimated Enrollment


Start Date

September 2003

Completion Date

April 2006

Primary Completion Date

September 2004

Eligibility Criteria


          -  HIV positive

          -  Presence of internal anal lesions with histologically confirmed high-grade squamous
             intraepithelial neoplasia with at least 1 positive margin

               -  No more than 3 lesions, each no more than 10 mm in diameter

          -  No evidence of microscopic invasion in any anal biopsy specimens

          -  No history of anal cancer



          -  Over 18

        Performance status

          -  Karnofsky 70-100%

        Life expectancy

          -  Not specified


          -  Platelet count at least 50,000/mm^3

          -  CD4 count at least 50 cells/mm^3


          -  Not specified


          -  Not specified


          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No allergy to lidocaine

          -  No anal insertions, including enemas or anal intercourse, for 24 hours before and at
             least 1 week after study treatment

          -  No prior severe photosensitivity reaction

          -  No active opportunistic infection

          -  No concurrent neoplasia requiring cytotoxic therapy


        Biologic therapy

          -  Not specified


          -  Not specified

        Endocrine therapy

          -  Not specified


          -  Not specified


          -  Not specified


          -  Must be on stable regimen of highly active antiretroviral therapy (HAART) for at least
             12 weeks prior to study entry unless CD4 count > 200/mm^3 AND no plans to initiate
             HAART within the next 3 months

          -  More than 14 days since prior acute treatment for an infection or other medical

          -  No prior infrared coagulation for anal dysplasia




18 Years - N/A

Accepts Healthy Volunteers



Elizabeth Stier, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

AIDS Malignancy Consortium


 National Cancer Institute (NCI)

Study Sponsor

Elizabeth Stier, MD, Study Chair, Memorial Sloan Kettering Cancer Center

Verification Date

September 2014