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

Primary Purpose

Anal Cancer, Precancerous Condition

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
infrared photocoagulation therapy
Infrared Coagulator
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Cancer focused on measuring anal cancer, high-grade squamous intraepithelial lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center
  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infrared coagulator

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 6, 2003
Last Updated
September 16, 2014
Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00066430
Brief Title
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
Official Title
Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer, Precancerous Condition
Keywords
anal cancer, high-grade squamous intraepithelial lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infrared coagulator
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
infrared photocoagulation therapy
Intervention Type
Device
Intervention Name(s)
Infrared Coagulator
Other Intervention Name(s)
Redfield Infrared Coagulator (IRC) 2100
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Stier, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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