Eligibility And Dosing In A Phase I Trial Of Lmb2

The phase I trial of LMB-2 began in 1996 and included patients with a histologically confirmed diagnosis of Hodgkin's disease (HD), NHL, or leukemia with evidence of CD25 on malignant cells, except in HD not amenable to biopsy.58 All patients had prior standard and salvage therapy (see Table 33.2), and those with indolent disease were in need of treatment. For firsttime or repeat cycles, patients could not have high levels of neutralizing antibodies. LMB-2 was administered for three doses by 30-min infusion (q.o.d. X 3). The maximum tolerated dose (MTD) was defined as the highest dose level for which 0-1 out of 6 patients had dose limiting toxicity (DLT). Patients without progressive disease or neutralizing antibodies could be retreated, and could be dose escalated to the dose level below that which new patients were permitted to receive. Plasma levels of LMB-2 were quantitated by a cytotoxicity assay and enzyme-linked immunosorbent assays.

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