Hybrid High-Dose Bolus/Continuous Infusion Interleukin-2 in Patients with Metastatic Renal Cell Carcinoma: A Phase II Trial of the National Biotherapy Study Group

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Abstract
Background Interleukin-2 (IL-2) is an active agent for the treatment of renal cell carcinoma. In animal studies, polyethylene glycol conjugated (PEG) IL-2 was found to be effective in certain IL-2-resistant models. When bolus/infusion IL-2 was administered to approximate the pharmacokinetics of PEG-IL-2, resistance was also overcome in these models. Based on these observations, the National Biotherapy Study Group (NBSG) previously had conducted a pilot study (NBSG 90-01) and then a phase I trial of a hybrid regimen of bolus IL-2 followed by continuous IL-2 (NBSG 91-04). Methods In the current study, NBSG 92-09, a phase II trial was conducted in patients with metastatic renal cell carcinoma using IL-2 at a dose of 36 MIU/m2 followed by a 72-hour continuous infusion of IL-2 at 18MIU/m2 per day, so that over 3 days a total of 90MIU/m2 of IL-2 were delivered; the same amount as previously given during 5 days of continuous intravenous (IV) IL-2 at 18MIU/m2 per day. This was repeated every 2 weeks for 2 months,...

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