| Literature DB >> 2924376 |
P J Creaven1, D E Brenner, J W Cowens, R P Huben, R M Wolf, H Takita, S G Arbuck, M S Razack, A D Proefrock.
Abstract
A phase I trial of human recombinant tumor necrosis factor (rH-TNF) has been carried out in patients with advanced solid tumors. Sixty-six courses of the drug were given by 1 h IV infusion, daily for 5 days to 33 patients at doses of 5, 10, 20, 30, 45, 60, and 80 x 10(4) U/m2/day. All patients received isotonic saline (up to 21/day) and either indomethacin or ketoprofen. Acute toxicity resembled that seen with the phase I study of a single dose (5). Dose limiting toxicity was acute, rapidly reversible, hepatic dysfunction and hypotension. Hypertension during drug infusion and dyspnea were marked in some patients. There was one complete and one minor response, both in patients with renal cell carcinoma. The dose of 80 x 10(4) U/m2/day x 5 was poorly tolerated and the recommended starting dose for phase II studies is 60 x 10(4) U/m2/day x 5. Caution is recommended in treating patients with pre-existing hepatic function abnormalities, hypertension, hypotension or significant obstructive airway disease.Entities:
Mesh：
Substances：
Year: 1989 PMID： 2924376 DOI： 10.1007/BF00267953
Source DB: PubMed Journal: Cancer Chemother Pharmacol ISSN： 0344-5704 Impact factor: 3.333