Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: High-grade squamous intraepithelial lesions of the skin near the anus are caused by the human papillomavirus (HPV). Antiviral drugs,, such as cidofovir, act against viruses and may stop these lesions from becoming cancer.

PURPOSE: This phase II trial is studying the side effects and how well topical cidofovir works in treating HIV-infected patients with high-grade squamous intraepithelial lesions of the skin near the anus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Cidofovir

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed perianal high-grade squamous intraepithelial lesions (HSIL) within the past 12 weeks

• The perianal skin (i.e., perianus) is defined as extending radially 5 cm from the anal verge

• Lesions must cover a surface area of ≥ 3 square centimeters

• Lesions extending outside the perianus (e.g., vulvar lesions on the posterior perineum bordering the perianus) are allowed

• Serologic documentation of HIV infection AND meets 1 of the following criteria:

• Has been on stable highly active anti-retroviral therapy (HAART) for ≥ 12 weeks prior to study entry

• Has a CD4 count of > 200/mm³ AND is not receiving anti-retroviral therapy OR is currently receiving a non-HAART* anti-retroviral regimen with no plans to initiate HAART within the next 12 weeks NOTE: * A non-HAART regimen is considered to be a therapy that does not include a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor

• No untreated invasive cancer of the lower genital tract

• No concurrent neoplasia requiring cytotoxic therapy

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Life expectancy ≥ 3 months

• Hemoglobin ≥ 8 g/dL

• ANC ≥ 1,000/mm³

• Platelet count ≥ 75,000/mm³

• Creatinine < 1.5 times upper limit of normal (ULN)

• Total or conjugated (direct) bilirubin ≤ 2.5 times ULN

• AST and ALT ≤ 3 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study therapy

• No acute, opportunistic infection other than oral thrush, yeast vaginitis, or genital herpes within the past 14 days

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior ablative or surgical treatment of perianal dysplasia

• At least 4 weeks since prior topical treatment for perianal dysplasia

• If any prior treatment caused significant trauma to ther area, healing should occur prior to starting treatment

• More than 14 days since prior acute treatment for infection (other than for oral thrush, yeast vaginitis, or genital herpes) or other serious medical illness

• No concurrent corticosteroids other than replacement doses

• No other concurrent investigational drugs except IND-approved anti-retroviral agents

• No concurrent systemic cytotoxic chemotherapy