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

Phase 1

Completed

• Conditions: Anal Cancer; Precancerous Condition
• Interventions: Procedure: infrared photocoagulation therapy; Device: Infrared Coagulator

• Registration Number: NCT00066430
• Lead Sponsor: AIDS Malignancy Consortium

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

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 Timeline

• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Study Start: 2003-09
• Primary Completion: 2004-09
• Study Completion: 2006-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infrared coagulator	infrared photocoagulation therapy	-
Infrared coagulator	Infrared Coagulator	-

Trial Locations

Locations (2)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States