Anal Cancer Clinical Trial
Official title:
Phase IIA Trial of 1% Topical Cidofovir for Treatment of High-Grade Perianal Squamous Intraepithelial Lesions in HIV-Infected Men and Women
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.
OBJECTIVES:
Primary
- To evaluate the safety and tolerability of topical cidofovir in HIV-infected patients
with perianal high-grade squamous intraepithelial lesions (HSIL).
- To estimate the regression rate of perianal HSIL in patients treated with this regimen.
Secondary
- To determine the human papilloma virus (HPV) DNA types and HPV strain variants present
in perianal HSIL and normal perianal tissue.
- To determine if clinical regression of perianal HSIL is associated with clearance of HPV
DNA.
- To identify the HPV DNA types present in the anus and cervix and compare them with the
HPV DNA present in the perianus in order to determine if the HPV types associated with
the perianal lesions are the same as those infecting the anus and cervix.
- To determine if there are abnormally methylated genes in perianal HSIL compared with
normal perianal tissue and if these genes are the same or different from those that have
been previously identified in anal and cervical dysplasia.
- To determine whether methylated genes are changed after treatment with cidofovir.
- To characterize differences in gene expression in perianal HSIL compared with normal
perianal tissue.
- To examine changes in gene expression in perianal HSIL after exposure to cidofovir using
RNA microarray analysis and confirm results with real-time polymerase chain reaction.
- To correlate pretreatment CD4 count, viral load, lesion size, methylation pattern,
and/or HPV type and strain with the clinical efficacy of topical cidofovir.
OUTLINE: This is a multicenter study.
Patients apply topical cidofovir to the perianus once daily on days 1-5. Patients undergo
punch biopsy of pretreatment lesional biopsy sites on day 14. Beginning 2-4 weeks after
biopsy, patients receive course 2 of cidofovir therapy. Subsequent treatment repeats every 14
days for up to 6 courses* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive a total of 6 courses of study therapy.
Patients undergo collection of tumor and normal tissue for histopathological and molecular
correlative studies. Punch biopsies are obtained at baseline, after the first course of
therapy, and at 6 weeks after completion of therapy. Tissue samples are examined for
histopathology, human papilloma virus (HPV)DNA typing, DNA methylation, and gene expression
(via RNA microarray analysis and polymerase chain reaction).
After completion of study therapy, patients are followed at 6 weeks.
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