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

Anal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066430
• Other study ID #: AMC-032
• Secondary ID: CDR0000316109
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2003
• Last updated: September 16, 2014
• Start date: September 2003
• Est. completion date: April 2006

Study information

• Verified date: September 2014
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2006
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,