Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia

NCT01164722 | Completed Phase 3 Results DMC

• 2 other identifiers: AMC-076U01CA121947
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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 coagulator ablation to see how well it works compared to observation in preventing anal cancer in HIV-positive patients with anal neoplasia.

Conditions

Anal Cancer; Neoplasm of Uncertain Malignant Potential; Nonneoplastic Condition; Precancerous Condition

Keywords

anal cancer; HIV infection; human papilloma virus infection; neoplasm of uncertain malignant potential; high-grade squamous intraepithelial lesion

Outcome Measures

Primary Outcomes (1)

• Complete Response Through 1 Year

  No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.

  1 year post treatment

Secondary Outcomes (4)

• Tolerability and Safety of Infrared Coagulator Ablation

  All study visits through year 2

• Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year

  1 year on study

• Recurrence Rate at 1 Year

  1 year on study

• Incidence of Metachronous Lesions

  one year on study

Study Arms (2)

Arm I: Infrared coagulator treatment

EXPERIMENTAL

Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.

Device: infrared photocoagulation therapy

Arm II: Expectant management

ACTIVE COMPARATOR

Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.

Other: clinical observation

Interventions

clinical observation OTHER

Patients undergo observation

Arm II: Expectant management

infrared photocoagulation therapy DEVICE

Anal infrared coagulator ablation

Also known as: Redfield Infrared Coagulator, Redfield IRC

Arm I: Infrared coagulator treatment

Eligibility Criteria

• Age: 27 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator
• University of Arkansas: collaborator

Study Sites (7)

UCLA Clinical AIDS Research and Education (CARE) Center

Los Angeles, California, 90095-1793, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

Laser Surgery Care

New York, New York, 10010, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Benaroya Research Institute at Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• Goldstone SE, Lensing SY, Stier EA, Darragh T, Lee JY, van Zante A, Jay N, Berry-Lawhorn JM, Cranston RD, Mitsuyasu R, Aboulafia D, Palefsky JM, Wilkin T. A Randomized Clinical Trial of Infrared Coagulation Ablation Versus Active Monitoring of Intra-anal High-grade Dysplasia in Adults With Human Immunodeficiency Virus Infection: An AIDS Malignancy Consortium Trial. Clin Infect Dis. 2019 Mar 19;68(7):1204-1212. doi: 10.1093/cid/ciy615.

  PMID: 30060087 DERIVED

MeSH Terms

Conditions

Anus Neoplasms; Precancerous Conditions; HIV Infections; Papillomavirus Infections; Squamous Intraepithelial Lesions

Interventions

Watchful Waiting; Light Coagulation

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Hemostatic Techniques; Therapeutics; Hemostasis, Surgical; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures

Results Point of Contact

• Title: Group Statistician
• Organization: AIDS Malignancy Consortium

jylee@uams.edu

1-501-526-6712

Study Officials

• Stephen E. Goldstone, MD

  Laser Surgery Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 19, 2010
• Study Start: April 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: August 4, 2020
• Results First Posted: October 31, 2016

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)