Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Clinical Trials of FIAC at Memorial Sloan-Kettering Cancer Center
Clinical Trials of FIAC at Memorial Sloan-Kettering Cancer Center
Pages 42-50
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From page 42... ...
the common and morbidity-producing occurrence of clinically active herpes group viral infections in patients with immunocompromise because of either their underlying disease or immunosuppressive therapy for neoplastic disease and (2) the prior demonstration of potent anti-herpes group virus activity by FIAC in cell culture systems and in mice that had been inoculated with ordinarily lethal doses of HSV-1.
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From page 43... ...
The antiviral activity was believed to be due to phosphorylation by the pyrimidine nucleoside kineses induced by the virus in infected cells (and then cellular conversion to diand triphosphates) and subsequent inhibition of virus-encoded DNA polymerases (Lopez et al., 19801.
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From page 44... ...
score status of the study patients was only 60 and the principal justifications offered for a clinical trial involving such poorly performing patients were that the study was being carried out before the approval of acyclovir for the treatment of such patients and that FIAC showed minimal toxicity at therapeutic doses in the murine HSV model system. The design was one of an acute study; dosing of patients was at 60, 120,240,400, or 600 mglm21day (two divided doses)
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From page 45... ...
occurred in two patients whose VZV infection spread to the viscera and appear likely to have been due to the extensive nature of the viral infections. Two other patients, with HSV infections, died of their underlying diseases aiEter their viral cultures had become negative within 4 days of initiating treatment with FTAC.
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From page 46... ...
They felt that the temporal relationship between FIAC treatment and the necrologic and pulmonary complications noted in this trial warranted caution in undertaking antiviral therapy in patients with AIDS.
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From page 47... ...
Another patient died on the 12th day after completing therapy and had disseminated CMV disease which included brain involvement. In two patients receiving 300-400 mg of FlAC per m2/day, sudden hypotension and pulmonary edema occurred after 9 and 14 doses had been administered respectively.
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From page 48... ...
Among the six patients taking the lower daily doses only three reported mild nausea and rarely required antiemetics. The response of VZV infections to oral FlAC therapy was excellent, and no new cutaneous lesions were observed after 72 hours of therapy in 24 of 26 patients.
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From page 49... ...
Results were evaluable for 31 of the 34 subjects. In those subjects treated with FIAC the clinical response was superior to the response with Ara-A: the median time to formation of the last new vesicle was reduced by approximately 3 days' crusting occurred in a significantly greater proportion of patients within the first 72 hours after the initiation of treatment, the disappearance of pain occurred earlier, and the cutaneous dissemination of zoster occurred less frequently (in 0 of 17 patients receiving FIAC versus 2 of 16 treated with Ara-A)
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From page 50... ...
Its efficacy against CMV was unclear because of the uncertainty of the diagnosis in many patients and the steady downhill course of many of the seriously ill patients. Toxicity appeared to be manifested primarily as hematopoietic suppression and a mild elevation in AST levels.
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