A phase I/II trial of intratumoral endoscopic ultrasound injection of @entity18886 with intravenous @entity136 in unresectable XXXX .

@entity1 @entity3123 @entity788 @entity137 @entity295 @entity2003 @entity5 @entity420 @entity136 @entity3 @entity18886
PURPOSE: Localized @entity3123 is rarely resectable and is resistant to conventional therapies. @entity18886 ( @entity18886 ) is an E1B-55kD gene-deleted replication-selective adenovirus that preferentially replicates in and kills malignant cells. Endoscopic ultrasound (EUS) has the potential to conveniently and accurately deliver local therapy to the pancreas. Therefore, we undertook a trial of the feasibility, tolerability, and efficacy of EUS injection of @entity18886 into unresectable @entity3123 . EXPERIMENTAL DESIGN: Twenty-one @entity1 with locally advanced @entity420 or with @entity3 , but minimal or absent liver metastases, underwent eight sessions of @entity18886 delivered by EUS injection into the primary @entity788 over 8 weeks. The final four treatments were given in combination with @entity136 (i.v., 1,000 mg/m(2)). @entity1 received 2 x 10(10) (n = 3) or 2 x 10(11) (n = 18) virus particles/treatment. RESULTS: After combination therapy, 2 @entity1 had partial regressions of the injected @entity5 , 2 had minor responses, 6 had stable disease, and 11 had progressive disease or had to go off study because of treatment @entity137 . No clinical @entity788 occurred despite mild, transient elevations in lipase in a minority of @entity1 . Two @entity1 had @entity295 before the institution of prophylactic oral antibiotics. Two @entity1 had duodenal perforations from the @entity2003 . No perforations occurred after the protocol was changed to transgastic injections only. CONCLUSIONS: This study indicates that @entity18886 injection via EUS into @entity3123 by the transgastic route with prophylactic antibiotics is feasible and generally well tolerated either alone or in combination with @entity136 . Transgastric EUS-guided injection is a new and practical method of delivering biological agents to @entity788 .
