Phase II study of recombinant human tumor necrosis factor in colorectal carcinoma.

Fifteen patients with colorectal carcinoma received a 30-min intravenous infusion of recombinant human tumor necrosis factor (rHuTNF) to investigate the value of rHuTNF in the treatment of colorectal carcinoma. Patients received 5 x 10(5) U/m2 (217 micrograms/m2) on day 1, and in the absence of serious side effects 10 x 10(5) U/m2 (435 micrograms/m2) on day 3 and 15 x 10(5) U/m2 (652 micrograms/m2) on day 5. The cycle was repeated on day 28. Full dose escalation was possible in all patients. There was a minor response in one patient (disappearance of retroperitoneal lymph nodes). All other patients showed progressive disease. At the dose and schedule used, rHuTNF had minimal therapeutic activity in colorectal carcinoma.