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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


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, 

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