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.

Study Overview

• Status: Completed
• Conditions: Precancerous Condition; Anal Cancer
• Intervention / Treatment: Procedure: infrared photocoagulation therapy; Device: Infrared Coagulator

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Comprehensive Cancer Center
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Redfield Infrared Coagulator (IRC) 2100

Collaborators and Investigators

• Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Elizabeth Stier, MD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: August 6, 2003
• First Submitted That Met QC Criteria: August 6, 2003
• First Posted (Estimate): August 7, 2003

Study Record Updates

• Last Update Posted (Estimate): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: anal cancer; high-grade squamous intraepithelial lesion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Precancerous Conditions; Anus Neoplasms
• Other Study ID Numbers: AMC-032; CDR0000316109 (Other Identifier: NCI)