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

A

AIDS Malignancy Consortium

Status and phase

Completed
Phase 1

Conditions

Anal Cancer
Precancerous Condition

Treatments

Procedure: infrared photocoagulation therapy
Device: Infrared Coagulator

Study type

Interventional

Funder types

NETWORK
NIH

Identifiers

NCT00066430
AMC-032
CDR0000316109 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Infrared coagulator
Experimental group
Treatment:
Device: Infrared Coagulator
Procedure: infrared photocoagulation therapy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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