Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
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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 |
| 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 |
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| 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 | |
| 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: | CDR0000316109, AMC-032 |
| Study First Received: | August 6, 2003 |
| Last Updated: | January 22, 2013 |
| 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 Neoplasms Precancerous Conditions Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on February 26, 2013
