Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, DiagnosticActive18 and overNCI, OtherAMC-058
U01CA121947, CDR0000590397, NCT00695422

Trial Description

Summary

RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination, and anal endoscopy and biopsy, may help find and diagnose anal and genital human papillomavirus infection and squamous intraepithelial lesions and help doctors plan better treatment.

PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS cancer clinical trial.

Further Study Information

OBJECTIVES:

Primary

  • To determine if various pharmacotherapeutic agents investigated in primary AIDS Malignancy Clinical Trials (AMC) for diseases other than human papillomavirus (HPV)-associated neoplasia have any preliminary evidence of activity against anogenital HPV infection or anogenital squamous intraepithelial lesions (ASIL) in HIV-positive patients participating in these trials.
  • To describe changes in the types of anal HPV present and the prevalence of ASIL in patients treated on these studies.
  • To evaluate cervical HPV infection and cervical/vulvovaginal disease in HIV-positive women participating in these trials.
  • To describe changes in cervical HPV infection and cervical/vulvovaginal disease in these women after undergoing various study treatments.

OUTLINE: This is a multicenter study.

Patients undergo anal swab collection at baseline to obtain samples for anal cytology, anal human papillomavirus (HPV) typing, and other HPV-related testing (e.g., HPV viral load). Digital rectal examinations (DRE) are also performed as part of the baseline physical examination. Female patients also undergo cervical swab collection for cervical HPV testing and cytology, as well as colposcopy (if available) of the cervix and vulvovaginal region to completely assess lower genital tract HPV-related lesions. At sites where high-resolution anoscopy (HRA) is available, patients are encouraged, but not required, to have an HRA with biopsy of any visualized lesions within 30 days of collection of the swabs.

After baseline assessments, patients undergo treatment with the investigative agent according to the study protocol requirements. If study treatment continues beyond 6 months, additional anal and cervical swabs are obtained for anal and cervical HPV and cytology along with DREs every 6 months until completion of study treatment and at the final study visit. Patients may also undergo additional HRA with biopsy and/or colposcopy of the lower genital tract with biopsy (women only) at this time. Patients with an abnormal anal cytology or histology are referred for HRA per local standard of care. If HRA is not available at the treatment site, patients undergo a DRE, and those with an abnormal DRE are referred for evaluation by a surgeon.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Serologic documentation of HIV infection by any FDA-approved tests
  • Enrolled in an AIDS Malignancy Clinical Trials Consortium (AMC) clinical trial of any new or existing pharmacotherapeutic agent for treatment of disease other than human papillomavirus (HPV)-associated neoplasia
  • AMC study must have an accrual target of > 15 patients

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
  • Life expectancy ≥ 3 months
  • Not pregnant or nursing
  • Patients receiving myelosuppressive therapy must meet the following criteria:
  • ANC > 1,000/μL
  • Platelet count > 50,000/μL
  • Evaluated before treatment or completely recovered from their nadir
  • Able to understand and willing to sign a written informed consent document
  • No bleeding disorder or requirement for anticoagulation that would contraindicate any biopsy of the anal canal

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

AIDS Associated Malignancies Clinical Trials Consortium

  • National Cancer Institute
  • EMMES Corporation
J. Michael Berry, Principal Investigator
J. Michael Berry, MD
Ph: 877-827-3222

Trial Sites

U.S.A.

California
La Jolla

Rebecca and John Moores UCSD Cancer Center

Clinical Trials Office - Rebecca and John Moores UCSD Cancer
Ph: 858-822-5354
Email: cancercto@ucsd.edu

William Wachsman, MD
Principal Investigator

Los Angeles

UCLA Clinical AIDS Research and Education (CARE) Center

Ronald T. Mitsuyasu, MD
Ph: 310-557-1893
Email: rmitsuya@mednet.ucla.edu

Ronald Mitsuyasu, MD
Principal Investigator

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center

Clinical Trials Office - UCSF Helen Diller Family Comprehensi
Ph: 877-827-3222

J M Berry, MD
Principal Investigator

Massachusetts
Boston

Beth Israel Deaconess Medical Center

Clinical Trials Office - Beth Israel Deaconess Medical Center
Ph: 617-667-9925

Ayad Hamdan, MD
Principal Investigator

Boston University Cancer Research Center

Clinical Trials Office - Boston University Cancer Research Cen
Ph: 617-638-8265

Timothy Cooley
Principal Investigator

New York
New York

Memorial Sloan-Kettering Cancer Center

Mark Dickson, MD
Ph: 212-639-5218
Email: dicksonm@mskcc.org

Mark Dickson, MD
Principal Investigator

Texas
Houston

Baylor University Medical Center - Houston

Elizabeth Y. Chiao, MD, MPH
Ph: 713-798-8070

Elizabeth Y. Chiao
Principal Investigator

Washington
Seattle

Benaroya Research Institute at Virginia Mason Medical Center

Clinical Trials Office - Benaroya Research Institute
Ph: 206-583-6526

David Aboulafia, MD
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00695422
ClinicalTrials.gov processed this data on April 13, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.