Phase II clinical trial of high-dose recombinant human tumor necrosis factor
- Cite this article as:
- Lenk, H., Tanneberger, S., Müller, U. et al. Cancer Chemother. Pharmacol. (1989) 24: 391. doi:10.1007/BF00257449
Based on a phase I study in 1986, 22 patients have been entered in a phase II study of high-dose human tumor necrosis factor (rH-TNF) since May 1987. Of these patients, 18 are evaluable at present, 2 are still under investigation, and 2 have dropped out. All had advanced stages of cancer (9 soft-tissue sarcomas, 3 melanomas, 5 hypernephromas) and inclusion in the study was ethically acceptable (informed consent). The daily dose of rH-TNF was 15×105 units/m2, escalated to 21×105 units/m2 (683–956 μg/m2 every week; range 1–6 cycles). Additional prophylactic ketoprofen administration was carried out. Of the 18 evaluable patients, 4 responsed with no change (2/4, clinical improvement) and 14 showed progressive disease. The main toxicities observed were hypotension (decrease in systolic blood pressure, 21–60 Torr), leukocytosis, increases in ALAT/ASAT (WHO grade 0–4), fever (WHO grade 1–2), chills (mild to moderate), neurotoxicity (WHO grade 0–2), and nausea/vomiting (WHO grade 0–3).