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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
  Purpose

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.


Condition Intervention Phase
Anal Cancer
Precancerous Condition
Procedure: infrared photocoagulation therapy
Device: Infrared Coagulator
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study

Resource links provided by NLM:


Further study details as provided by AIDS Malignancy Clinical Trials Consortium:

Enrollment: 18
Study Start Date: September 2003
Study Completion Date: April 2006
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infrared coagulator 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066430

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
Investigators
Study Chair: Elizabeth Stier, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT00066430     History of Changes
Other Study ID Numbers: AMC-032, CDR0000316109
Study First Received: August 6, 2003
Last Updated: September 16, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by AIDS Malignancy Clinical Trials Consortium:
anal cancer
high-grade squamous intraepithelial lesion

Additional relevant MeSH terms:
Anus Neoplasms
Precancerous Conditions
Anus Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014