ANTIVITRONECTIN RECEPTOR HUMANIZED MONOCLONAL ANTIBODY IN METASTATIC CANCER

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This is an open label Phase I study of Vitaxin to establish any toxicity/ adverse events over a limited dose range given as two infusions 3 weeks apart at doses of 10 mg, 50 mg, or 200 mg. Pharmacokinetics, antibody response to Vitaxin (HAMA) and anti-tumor effects will be documented. The ability of 99Tc-Vitaxin (imaging probe) to ocalize to tumor sites will be determined prior to Vitaxin infusion and, if localization occurs, follow-up 99Tc-V probe studies will be done to assess the effect of Vitaxin treatment on radiolocalization (available 6v' sites). We recognize that this use of radiolabeled antibody to analyze available antigen sites is novel but we believe that the vascular site of 6v'3 targets may make this approach feasible. The initial Phase I trial observed a short T1/2 at the 0.1 mg/kg dose level suggesting that the imaging strategy may work. The study will provide worthwhile observations relevant to Vitaxin tolerance, pharmacokinetics, HAMA, and anti-tumor effects with potential to provide novel observations on receptor binding and "blockade."