Drug administration
Stock, Cancer
ADVERSE REACTIONS, DISEASE, CANCER
Drug was supplied (Cancer Research UK) and manufactured as single-use aseptic 1 mL fill in 2 mL glass vials containing a solution of MOv18 IgE at a concentration of 1 mg/mL at pH6.5 with 0.1 M sodium citrate, 30 g/L L-arginine, 50 g/L sucrose and 0.02% polysorbate 20 in water for injection. Stock was stored at 5 ± 3 °C, initially diluted to a concentration of 100 μg/mL in 0.9% sodium chloride, then infused over 90 min through a peripheral line in a total volume of 250 ml 0.9% saline. A shorter infusion time for subsequent doses of 60 min was allowed if no adverse reactions are encountered. Vital signs were monitored during the infusion and at regular intervals afterwards. Patients were hospitalised overnight following the first administration to facilitate safety monitoring procedures.The protocol-defined treatment regimen was 6 doses of MOv18 IgE administered weekly, following which disease response was reassessed using CT. Patients tolerating treatment and appearing to benefit from treatment were offered the option of continuing into a maintenance phase of two-weekly dosing for a further 6 weeks (Fig. 