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A phase I clinical trial of recombinant human tumor necrosis factor

We performed a Phase I assessment of recombinant human tumor necrosis factor (rTNF‐α) in 27 patients with advanced solid neoplasms. Therapy consisted of a 30‐minute intravenous (IV) infusion on days 1 through 5, every 2 to 3 weeks. Daily doses ranged from 5 μg/m2 to 200 μg/m2. Dose‐limiting sequelae were hypotension, rigors, and phlebitis. Transient fatigue and fever (median, 38°C) were not clearly dose‐related between 5 μg/m2/d and 150 μg/m2/d. Other reversible complications in three patients included transient leukopenia (leukocyte count, 1.3,1.2 × 103/μl in two patients) at a dose of 5 μg/m2/d and 150 μg/m2/d, respectively; and thrombocytopenia (leukocyte count, 73 × 103/μl) at 10 μg/m2/d. Among 22 patients with initial and subsequent differential counts, the median number of eosinophils at the commencement of therapy was 182 cells/μl compared with a subsequent median of 462 cells/μl. We also detected hypertriglyceridemia in all patients. The median baseline increased from 93 mg/dl (range, 56 to 219 mg/dl) to 203 mg/dl (range, 94 to 454 mg/dl). From our experience, a clinically manageable outpatient regimen for Phase II trials consists of rTNF‐α (150 μg/m2) followed by a 1‐hour IV infusion of 500 ml of normal saline to abrogate hypotension daily for 5 days every 2 weeks for four cycles, then every 3 weeks thereafter to facilitate recovery from constitutional sequelae.