Clinical trial NCT00066430: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anal Cancer
Precancerous Condition
Keywords: anal cancer
high-grade squamous intraepithelial lesion
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Stier, MD
role: STUDY_CHAIR
References: