Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0085593 (chills)
 4,268 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A Phase I study of rHu-TNF (PT-050) was conducted in patients with various malignant tumors refractory to conventional therapy. rHu-TNF was administered by 30-min intravenous (i.v.) infusion or intratumor (i.t.) injection. The starting dose of 1 X 10(5) U/body was increased to 5 X 10(6) U/body in the i.v. group and to 2 X 10(6) U/body in the i.t. group. rHu-TNF was evaluated in 41 patients among the enrolled 43 patients of the i.v. group, and in 9 out of 10 in the i.t. group. In the i.v. group, fever (68.3%), chills (75.6%), hypotension (46.3%), general fatigue (34.1%), nausea/vomiting (22.0%/22.0%), pain in the extremities (17.1%), etc. were observed as adverse reactions (ADRs), and elevation of GOT/GPT (46.3%/43.9%), elevation of ALP(26.8%)and decrease in platelets (12.2%), etc. were observed as abnormal laboratory findings. Among these, hypotension was recognized as the dose-limiting factor and the maximum tolerated dose was considered to be 1 X 10(6) U/body. Plasma levels of rHu-TNF after 30-min i.v. administration were dose-related, and decreased with half-lives of 0.5-2.4 hours. In the i.t. group, ADRs occurred with a lower incidence than in the i.v. group except for fever, chills and general fatigue. Plasma levels after i.t. administration were all within the assay limit. Evident tissue necrosis was observed in the region where rHu-TNF was administered in the i.t. group.
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PMID:[A phase I study of recombinant human tumor necrosis factor (rHu-TNF: PT-050). The PT-050 Study Group]. 302 81

A phase I study of recombinant human tumor necrosis factor (rHu-TNF:PT-050) given by intravenous infusion over 30 min or by intratumoral administration was performed in 53 patients with various types of malignant tumors. The dose of rHu-TNF was started with 0.1 x 10(6) U/body for both intravenous infusion and intratumoral administration and increased to 5 x 10(6) U/body for intravenous infusion and 2 x 10(6) U/body for intratumoral administration. The side effects of rHu-TNF given by intravenous infusion included fever, shaking chills, hypotension, general malaise, nausea, and vomiting, and clinical laboratory tests showed elevations of GOT, GPT, and ALP, etc. Among these, only hypotension was dose-related and was considered to be a dose-limiting factor. The maximum tolerable dose estimated was 1 x 10(6) U/body. The plasma concentration of rHu-TNF after completion of a 30-min infusion was dose-dependent, and the elimination half-life was 0.5-2.4 hr. When the rHu-TNF was administered intratumorally, the frequency of side effects was low compared with intravenous infusion.
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PMID:Phase I study of recombinant human tumor necrosis factor (rHu-TNF:PT-050). 318 Jan 46