Phase I Trial of Intravesical Recombinant Adenovirus Mediated Interferon-α2b Formulated in Syn3 for Bacillus Calmette-Guérin Failures in Nonmuscle Invasive Bladder Cancer
作者： Colin P.N. Dinney , Mark B. Fisher , Neema Navai , Michael A. O'Donnell , David Cutler
DOI: 10.1016/J.JURO.2013.03.030
关键词: Urology 、 Genetic enhancement 、 Bladder cancer 、 Efficacy 、 Adenoviridae 、 Immunology 、 Medicine 、 Adverse effect 、 Interferon 、 Alpha interferon 、 BCG vaccine
摘要: Purpose: A phase I trial of intravesical recombinant adenovirus mediated interferon-α2b gene therapy (rAd-IFNα) formulated with the excipient SCH Syn3 was conducted in patients nonmuscle invasive bladder cancer who had disease recurrence after treatment bacillus Calmette-Guerin. The primary objective to determine safety rAd-IFNα/Syn3. Secondary end points were demonstrated effective rAd-IFNα expression and preliminary evidence clinical activity at 3 months.Materials Methods: total 17 recurrent Calmette-Guerin enrolled study. single (3 × 109 1011 particles per ml) administered. Patient evaluated for 12 or more weeks. Efficacy transfer determined by urine IFNα protein concentrations. Preliminary drug efficacy months.Results: Intravesical rAd-IFNα/Syn3 well tolerated as no...
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