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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
2
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pubmed:dateCreated |
1988-3-24
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pubmed:abstractText |
Recombinant human tumor necrosis factor (rH-TNF) is a cytotoxic monokine with pleiotropic effects. A phase I trial of rH-TNF was initiated using a five-day continuous intravenous (IV) infusion repeated every 28 days. Thirty-eight courses of therapy were administered to 19 patients. The starting dose was 5 X 10(4) U/m2/d, with escalations to 1.0 X 10(5), 2.0 X 10(5), 2.4 X 10(5), and 3.0 X 10(5) U/m2/d. Systemic side effects, including fever, chills, hypotension, fatigue, anorexia, and headaches, were mild and self-limiting. At the maximum tolerated dose of 3.0 X 10(5) U/m2/d, dose-limiting hematologic toxicity was manifested by transient thrombocytopenia and leukopenia. Elevated bilirubin levels were also seen at the higher dose levels. Lipoprotein analysis demonstrated that the five-day treatment with rH-TNF was associated with decreases in high-density lipoproteins, as well as increases in triglycerides and very-low-density lipoproteins. Pharmacokinetic studies using an enzyme-linked immunosorbent assay (ELISA) test indicated plasma rH-TNF levels less than 0.2 U/mL. The recommended phase II dose of rH-TNF administered as a five-day continuous infusion is 2.4 X 10(5) U/m2/d.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Feb
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pubmed:issn |
0732-183X
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
6
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
344-50
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pubmed:dateRevised |
2009-11-19
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pubmed:meshHeading |
pubmed-meshheading:3339398-Drug Evaluation,
pubmed-meshheading:3339398-Drug-Induced Liver Injury,
pubmed-meshheading:3339398-Female,
pubmed-meshheading:3339398-Hematologic Diseases,
pubmed-meshheading:3339398-Humans,
pubmed-meshheading:3339398-Lipoproteins,
pubmed-meshheading:3339398-Male,
pubmed-meshheading:3339398-Neoplasms,
pubmed-meshheading:3339398-Recombinant Proteins,
pubmed-meshheading:3339398-Tumor Necrosis Factor-alpha
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pubmed:year |
1988
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pubmed:articleTitle |
Recombinant human tumor necrosis factor administered as a five-day continuous infusion in cancer patients: phase I toxicity and effects on lipid metabolism.
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pubmed:affiliation |
Laboratory of Clinical Pharmacology, Dana-Farber Cancer Institute, Boston, MA 02115.
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pubmed:publicationType |
Journal Article,
Research Support, Non-U.S. Gov't
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