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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00066430
First received: August 6, 2003
Last updated: September 16, 2014
Last verified: September 2014

August 6, 2003
September 16, 2014
September 2003
September 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00066430 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study

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.

OBJECTIVES:

  • 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 procedure.
  • Determine the toxicity of this procedure in these patients.
  • Correlate CD4/CD8 count and HIV viral load with outcome in patients treated with this procedure.
  • Correlate outcome with human papilloma virus subtype in patients treated with this procedure.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anal Cancer
  • Precancerous Condition
  • Procedure: infrared photocoagulation therapy
  • Device: Infrared Coagulator
    IRC treatment of up to 3 HGAIN lesions at baseline (study initiation). A second IRC treatment may be administered for recurrent lesions at the 3 month visit.
    Other Name: Redfield Infrared Coagulator (IRC) 2100
Experimental: Infrared coagulator
Interventions:
  • Procedure: infrared photocoagulation therapy
  • Device: Infrared Coagulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2006
September 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 50,000/mm^3
  • CD4 count at least 50 cells/mm^3

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • 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 illness
  • No prior infrared coagulation for anal dysplasia
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066430
AMC-032, CDR0000316109
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Study Chair: Elizabeth Stier, MD Memorial Sloan-Kettering Cancer Center
AIDS Malignancy Clinical Trials Consortium
September 2014

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