Launching a Novel Preclinical Infrastructure: Comparative Oncology Trials Consortium Directed Therapeutic Targeting of TNFα to Cancer Vasculature
Figure 3
Schema representing the schedule for the multi-dose phase of RGD-A-TNF evaluation in dogs with spontaneous cancers.
This study was designed as an open label, multiple fixed-dose trial (i) to establish feasibility and (ii) to identify chronic and/or cumulative toxicity of repetitively administered RGD-A-TNF. Dogs received weekly doses (5×1012 TU intravenously) of RGD-A-TNF. Anticancer activity of this agent was evaluated using RECIST criteria. The treatment received population included dogs that received at least four weekly doses (i.e., one cycle 1). This population consisted of 14 dogs. Dogs were permitted to receive additional therapy in subsequent cycles if there was evidence of either stable disease or tumor response. Tumor measurements were recorded every two weeks with full restaging every 28 days.