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.
Schaadt
M
M
Medizinische Klinik I, University of Cologne, Cologne, F.R.G.
Pfreundschuh
M
M
Lorscheidt
G
G
Peters
K M
KM
Steinmetz
T
T
Diehl
V
V
D000293:Adolescent; D000328:Adult; D000368:Aged; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000601:surgery; D003131:Combined Modality Therapy; D004341:Drug Evaluation; D006801:Humans; D008875:Middle Aged; D011994:Recombinant Proteins; D014409:Tumor Necrosis Factor-alpha / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*
D011994:Recombinant Proteins; D014409:Tumor Necrosis Factor-alpha