Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN with
Syn3) when given intravesically to patients with high grade non-muscle invasive bladder
cancer who are refractory to or have relapsed from BCG therapy. The pharmacodynamics of
INSTILADRIN will also be studied by measuring the interferon (IFNα2b) levels excreted in the
urine. rAd-IFN is a non-replicating recombinant adenovirus type 5 (Ad5)-vector encoding the
interferon alpha-2b (IFNα2b) gene. Syn 3 is clinical surfactant excipient which enhances the
ability of the adenoviral vector to transfect cells in the bladder wall.