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


Phase 1
18 Years
N/A
Not Enrolling
Both
Anal Cancer, Precancerous Condition

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Elizabeth Stier, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000316109

NCT ID:

NCT00066430

Start Date:

September 2003

Completion Date:

April 2006

Related Keywords:

  • Anal Cancer
  • Precancerous Condition
  • anal cancer
  • high-grade squamous intraepithelial lesion
  • Anus Neoplasms
  • Neoplasms
  • Precancerous Conditions

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
UCSF Comprehensive Cancer CenterSan Francisco, California  94115