Phase I trial intramuscularly administered tumor necrosis factor in patients with advanced cancer Journal Article

  


Authors: Jakubowski, A. A.; Casper, E. S.; Gabrilove, J. L.; Templeton, M. A.; Sherwin, S. A.; Oettgen, H. F.
Article Title: Phase I trial intramuscularly administered tumor necrosis factor in patients with advanced cancer
Abstract: A phase I trial of intramuscularly administered recombinant human tumor necrosis factor (rTNF) was conducted in 19 adult patients with advanced solid tumors. The agent was administered daily for up to five consecutive days every other week for two to four courses. Doses of rTNF ranged from 5 to 200 μg/m2/d. Dose-limiting toxicities were encountered at doses > 100 μg/m2/d. Toxicities included tenderness, erythema and induration at the site of injection, fatigue, fever, chills, headache, anorexia, nausea, vomiting, and diarrhea. Moderate to marked reductions in WBC and platelet counts were observed regularly at the highest dose levels, but none were clinically significant. Hepatic enzyme elevation was seen frequently, and two patients developed hyperbilirubinemia. Only one of seven patients treated with doses > 100 μg/m2/d completed the planned course of therapy. Even at the highest dose levels, serum concentrations of rTNF could only rarely be detected in the serum. No therapeutic responses were observed. The maximal tolerated dose (MTD) of rTNF in this trial was 150 μg/m2/d, administered for two courses.
Keywords: adult; clinical article; aged; blood toxicity; phase 1 clinical trial; tumor necrosis factor; blood level; intramuscular drug administration; human; male; female; priority journal
Journal Title: Journal of Clinical Oncology
Volume: 7
Issue: 3
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1989-03-01
Start Page: 298
End Page: 303
Language: English
DOI: 10.1200/jco.1989.7.3.298
PUBMED: 2918329
PROVIDER: scopus
DOI/URL:

https://www.scopus.com/inward/record.uri?eid=2-s2.0-0024503384&doi=10.1200%2fJCO.1989.7.3.298&partnerID=40&md5=a057afd06261dc4dfd48f3aed84c2bb9
Notes: Article -- Export Date: 14 April 2020 -- Source: Scopus
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MSK Authors
  1. Ann Jakubowski
    457 Jakubowski
  2. Herbert F Oettgen
    130 Oettgen
  3. Ephraim S Casper
    108 Casper
  4. Janice Gabrilove
    122 Gabrilove
  5. Mary Agnes Templeton
    11 Templeton
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