Clinical trial NCT00550589 (phase 2, status: completed)
Conditions: anal cancer, precancerous condition
ICD codes: C21.1, C44.500, C44.590, D12.9, C21.8, Y95, D69.9, J94.9, L53.9, G47.01, G47.14, P28.9
Drugs: cidofovir
SMILES: NC1=NC(=O)N(C[C@@H](CO)OCP(O)(O)=O)C=C1
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