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

A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Sarcoma; Lymphoma; Precancerous Condition; Aids-related Malignancies
• Intervention / Treatment: Genetic: polymerase chain reaction; Other: cytology specimen collection procedure; Other: histological technique; Procedure: colposcopic biopsy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0658
      • Rebecca and John Moores UCSD Cancer Center
    • Los Angeles, California, United States, 90089-9181
      • USC/Norris Comprehensive Cancer Center and Hospital
    • Los Angeles, California, United States, 90095-1793
      • UCLA Clinical AIDS Research and Education (CARE) Center
    • San Francisco, California, United States, 94115
      • UCSF Helen Diller Family Comprehensive Cancer Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Cancer Research Center of Hawaii
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston University Cancer Research Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
  • Texas
    • Houston, Texas, United States, 77030-2707
      • Baylor University Medical Center - Houston
  • Washington
    • Seattle, Washington, United States, 98101
      • Benaroya Research Institute at Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll patients who are study participants on interventional AMC protocols for diseases other than HPV-associated neoplasia with an accrual goal of 15 patients or more.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Specimen Collection; Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.

Genetic: polymerase chain reaction; PCR for HPV DNA detection, performed on specimens collected at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.; Other: cytology specimen collection procedure; Detection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.; Other: histological technique; Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.; Procedure: colposcopic biopsy; Where observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)	Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials	Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies	Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Changes in anal HPV types present	Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Frequency of ASIL	Baseline, treatment discontinuation on parent protocol, final visit on parent protocol

Collaborators and Investigators

• Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); The Emmes Company, LLC
• Investigators: Principal Investigator: J. Michael Berry, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 14, 2008
• Primary Completion (ACTUAL): April 19, 2017
• Study Completion (ACTUAL): April 19, 2017

Study Registration Dates

• First Submitted: June 7, 2008
• First Submitted That Met QC Criteria: June 7, 2008
• First Posted (ESTIMATE): June 11, 2008

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: AIDS-related peripheral/systemic lymphoma; AIDS-related diffuse large cell lymphoma; AIDS-related immunoblastic large cell lymphoma; AIDS-related small noncleaved cell lymphoma; AIDS-related diffuse mixed cell lymphoma; AIDS-related diffuse small cleaved cell lymphoma; HIV Infections; AIDS-related lymphoblastic lymphoma; AIDS-related Kaposi sarcoma; human papilloma virus infection; AIDS-related primary CNS lymphoma; multicentric Castleman disease; low-grade squamous intraepithelial lesion; high-grade squamous intraepithelial lesion; AIDS-related malignancies
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Dysplasia; Neoplasms; Sarcoma; Lymphoma; Infections; Precancerous Conditions; Squamous Intraepithelial Lesions of the Cervix
• Other Study ID Numbers: AMC-058; U01CA121947 (U.S. NIH Grant/Contract); CDR0000590397 (OTHER: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No