Clinical trial NCT00695422: Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
Official title: A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aids-related Malignancies
Lymphoma
Precancerous Condition
Sarcoma
Keywords: high-grade squamous intraepithelial lesion
low-grade squamous intraepithelial lesion
human papilloma virus infection
AIDS-related diffuse large cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related Kaposi sarcoma
AIDS-related lymphoblastic lymphoma
AIDS-related malignancies
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
AIDS-related small noncleaved cell lymphoma
multicentric Castleman disease
HIV Infections
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: The Emmes Company, LLC
First posted: 2008-06-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

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

Primary outcomes:
measure: Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)
timeFrame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
measure: Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials
timeFrame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
measure: Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies
timeFrame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
measure: Changes in anal HPV types present
timeFrame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
measure: Frequency of ASIL
timeFrame: Baseline, treatment discontinuation on parent protocol, final visit on parent protocol
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Rebecca and John Moores UCSD Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Clinical AIDS Research and Education (CARE) Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii
state: Hawaii
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: Baylor University Medical Center - Houston
state: Texas
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: University of California, San Francisco
name: J. Michael Berry, MD
role: PRINCIPAL_INVESTIGATOR
References: