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A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults


Phase 3
27 Years
N/A
Open (Enrolling)
Both
Anal Cancer, Neoplasm of Uncertain Malignant Potential, Nonneoplastic Condition, Precancerous Condition

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Trial Information

A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults


OBJECTIVES:

Primary

- Evaluate the complete response rate at 3 months and 1 year in HIV-seropositive patients
with high-grade anal intraepithelial neoplasia (HGAIN) treated with infrared coagulator
(IRC) ablation versus observation.

Secondary

- Determine the tolerability and safety of IRC ablation versus observation in these
patients.

- Compare the proportion of patients with HGAIN at 1 year.

- Evaluate the response and recurrence rates at 1 year of individual lesions in patients
treated with this regimen vs observation.

- Determine the incidence of metachronous lesions in these patients.

- Compare the response and recurrence rates at 2 years of individual lesions in patients
under observation who subsequently received IRC ablation with the response and
recurrence rates at 1 year in patients initially treated with IRC.

OUTLINE: This is a multicenter study. Patients are stratified according to site. Patients
are randomized to 1 of 2 arms.

- Arm I: Infrared coagulator (IRC) contact tip is placed in direct contact with lesion
under high-resolution anoscopy (HRA) guidance for 1.5 seconds. IRC ablation is
reapplied until the level of submucosal vessels are reached.

- One week after each IRC ablation, patients complete a questionnaire regarding
pain, bleeding, and other complaints.

- Arm II: Patients receive standard of care and undergo observation. After 12 months,
patients may receive IRC ablation to all anal intraepithelial neoplasia lesions.

NOTE: Patients may receive a maximum of 6 IRC treatments while on study (3 per year).

Patients undergo a physical exam, digital rectal exam, anal cytology, and HRA at baseline
and periodically during study.

After completion of study therapy, patients are followed up periodically for 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of high-grade anal intraepithelial neoplasia (AIN) meeting the following:

- AIN2 and/or AIN3 confirmed by biopsy ≥ 2 weeks to ≤ 60 days before enrollment

- 1-3 lesions with each lesion ≤ 15 mm in diameter

- At least one high-grade AIN lesion is still visible at study entry

- HIV-infection documented by federally approved, licensed HIV-test in conjunction with
screening test (e.g., ELISA, western blot, or other test)

- HIV-infection, based on prior ELISA and western blot assays, recorded and
documented by another physician, allowed provided patient undergoes an approved
antibody test to confirm diagnosis

- Patients on concurrent anti-retroviral therapy with a history of HIV-positivity
based on an approved antibody test allowed

- Detectable plasma HIV-1 RNA also allowed

- No perianal AIN, perianal condyloma, or lower vulvar intraepithelial neoplasia or
condyloma requiring treatment

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Life expectancy ≥ 2 years

- CD4 count ≥ 200/mm³

- ANC > 750/mm³

- Platelet count ≥ 75,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- INR and aPTT normal

- Negative pregnancy test

- Fertile patients must use effective contraception

- Female patients must have undergone cervical pap smear (if having a cervix) and
gynecologic evaluation within the past 12 months

- Must be capable of complying with the requirements of this protocol

- Concurrent HPV-related disease allowed

- No history of anal cancer

- No acute infection or other serious medical illness requiring treatment within the
past 14 days

- Fungal infection of the skin or a sexually transmitted disease requiring
treatment allowed

- No concurrent malignancy requiring systemic therapy

- Kaposi sarcoma limited to the skin allowed

PRIOR CONCURRENT THERAPY:

- No prior infrared coagulator (IRC) ablation for high-grade anal intraepithelial
neoplasia (HGAIN)

- Prior HGAIN treated by any means other than IRC within the past 2 months allowed

- At least 5 days since prior coumadin or clopidogrel and ≥ 7 days after study therapy
before receiving coumadin or clopidogrel again

- No concurrent anticoagulant therapy other than aspirin or NSAIDs

- More than 3 months since prior and concurrent systemic corticosteroids, cytokines, or
immunomodulatory therapy (e.g., interferons) or local imiquimod

- No concurrent systemic therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Complete response at 3 months and 1 year

Outcome Time Frame:

3 months and 1 year post treatment

Safety Issue:

No

Principal Investigator

Stephen E. Goldstone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Laser Surgery Care

Authority:

United States: Federal Government

Study ID:

CDR0000681457

NCT ID:

NCT01164722

Start Date:

April 2011

Completion Date:

April 2015

Related Keywords:

  • Anal Cancer
  • Neoplasm of Uncertain Malignant Potential
  • Nonneoplastic Condition
  • Precancerous Condition
  • anal cancer
  • HIV infection
  • human papilloma virus infection
  • neoplasm of uncertain malignant potential
  • high-grade squamous intraepithelial lesion
  • Anus Neoplasms
  • Neoplasms
  • Precancerous Conditions

Name

Location

New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
UCLA Clinical AIDS Research and Education (CARE) CenterLos Angeles, California  90024
Boston University Cancer Research CenterBoston, Massachusetts  02118
Laser Surgery CareNew York, New York  10011