Phase 2
N=33
Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus
Anal Cancer · Precancerous Condition
Bottom Line
View on ClinicalTrials.gov: NCT00550589 ↗Enrolled (actual)
33
Serious AEs
9.1%
Results posted
Jun 2011
Primary outcome: Primary: Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL) — 0.515 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cidofovir (Drug); DNA methylation analysis (Genetic); gene expression analysis (Genetic); polymerase chain reaction (Genetic); biopsy (Procedure); histopathologic examination (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL) |
0.515 | — |
| PRIMARY Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0 |
3 | — |
| SECONDARY Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue |
16 | — |
| SECONDARY Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA |
2 | — |
| SECONDARY Identification of HPV-DNA Types Present in the Anus |
14 | — |
| SECONDARY Identification of Abnormally Methylated Genes in Perianal Dysplasia |
— | — |
| SECONDARY Distribution of Abnormally Methylated Genes Among HSIL, Low-grade Squamous Intraepithelial Lesions, and Normal Perianal Skin |
— | — |
| SECONDARY Changes in Gene Expression in Perianal HSIL After Exposure to Cidofovir as Assessed by RNA Microarray Analysis |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00550589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.