Status:
COMPLETED
Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
Anal Cancer
Neoplasm of Uncertain Malignant Potential
Eligibility:
All Genders
27+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Infrared coagulator ablation may be effective in preventing the development of anal cancer in patients with anal neoplasia PURPOSE: This randomized phase III trial is studying infrared coa...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01164722
Start Date
April 1 2011
End Date
July 1 2016
Last Update
August 4 2020
Active Locations (7)
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1
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90095-1793
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
3
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
4
Laser Surgery Care
New York, New York, United States, 10010