Recombinant human interleukin-4 (rhu IL-4) administered by the intravenous and subcutaneous routes in patients with advanced cancer--a phase I toxicity study and pharmacokinetic analysis.

2.50
Hdl Handle:
http://hdl.handle.net/10541/99920
Title:
Recombinant human interleukin-4 (rhu IL-4) administered by the intravenous and subcutaneous routes in patients with advanced cancer--a phase I toxicity study and pharmacokinetic analysis.
Authors:
Prendiville, Joseph A; Thatcher, Nick; Lind, Michael J; McIntosh, R; Ghosh, Anna K; Stern, Peter L; Crowther, Derek
Abstract:
19 patients with advanced cancer were entered into a phase I study of recombinant human interleukin-4 (rhu IL-4). The predominant clinical side-effects included flu-like symptoms, gastrointestinal upset, lethargy and transient hypotension. In addition, there were several cases of capillary leak syndrome. 2 cases of gastrointestinal haemorrhage occurred; this was life threatening in 1 patient. The maximum tolerated dose (MTD) was 400 micrograms/m2/day. Biochemical toxicity was limited to asymptomatic elevation of liver enzymes suggesting IL-4 induced liver damage. Pharmacokinetic analysis following the intravenous bolus injection has shown that IL-4 is rapidly cleared (mean T1/2 = 19 +/- 8.7 min) from a small compartment (mean Vd = 4.9 +/- 3.68 l) probably indicating that IL-4 is retained in the systemic circulation or at most the extracellular fluid volume. 2 patients with non-Hodgkin lymphomas (NHL) showed a transient response to IL-4 whilst a third patient with NHL showed transient disease progression.
Affiliation:
CRC Department of Medical Oncology, Christie Hospital NHS Trust, Manchester, U.K.
Citation:
Recombinant human interleukin-4 (rhu IL-4) administered by the intravenous and subcutaneous routes in patients with advanced cancer--a phase I toxicity study and pharmacokinetic analysis. 1993, 29A (12):1700-7 Eur. J. Cancer
Journal:
European Journal of Cancer
Issue Date:
1993
URI:
http://hdl.handle.net/10541/99920
DOI:
10.1016/0959-8049(93)90108-R
PubMed ID:
8398297
Type:
Article
Language:
en
ISSN:
0959-8049
Appears in Collections:
All Christie Publications ; All Paterson Institute for Cancer Research

Full metadata record

DC FieldValue Language
dc.contributor.authorPrendiville, Joseph Aen
dc.contributor.authorThatcher, Nicken
dc.contributor.authorLind, Michael Jen
dc.contributor.authorMcIntosh, Ren
dc.contributor.authorGhosh, Anna Ken
dc.contributor.authorStern, Peter Len
dc.contributor.authorCrowther, Dereken
dc.date.accessioned2010-05-27T14:37:02Z-
dc.date.available2010-05-27T14:37:02Z-
dc.date.issued1993-
dc.identifier.citationRecombinant human interleukin-4 (rhu IL-4) administered by the intravenous and subcutaneous routes in patients with advanced cancer--a phase I toxicity study and pharmacokinetic analysis. 1993, 29A (12):1700-7 Eur. J. Canceren
dc.identifier.issn0959-8049-
dc.identifier.pmid8398297-
dc.identifier.doi10.1016/0959-8049(93)90108-R-
dc.identifier.urihttp://hdl.handle.net/10541/99920-
dc.description.abstract19 patients with advanced cancer were entered into a phase I study of recombinant human interleukin-4 (rhu IL-4). The predominant clinical side-effects included flu-like symptoms, gastrointestinal upset, lethargy and transient hypotension. In addition, there were several cases of capillary leak syndrome. 2 cases of gastrointestinal haemorrhage occurred; this was life threatening in 1 patient. The maximum tolerated dose (MTD) was 400 micrograms/m2/day. Biochemical toxicity was limited to asymptomatic elevation of liver enzymes suggesting IL-4 induced liver damage. Pharmacokinetic analysis following the intravenous bolus injection has shown that IL-4 is rapidly cleared (mean T1/2 = 19 +/- 8.7 min) from a small compartment (mean Vd = 4.9 +/- 3.68 l) probably indicating that IL-4 is retained in the systemic circulation or at most the extracellular fluid volume. 2 patients with non-Hodgkin lymphomas (NHL) showed a transient response to IL-4 whilst a third patient with NHL showed transient disease progression.en
dc.language.isoenen
dc.subjectGastrointestinal Haemorrhageen
dc.subjectCanceren
dc.subject.meshAdult-
dc.subject.meshBiological Availability-
dc.subject.meshFemale-
dc.subject.meshGastrointestinal Hemorrhage-
dc.subject.meshHumans-
dc.subject.meshInjections, Intravenous-
dc.subject.meshInjections, Subcutaneous-
dc.subject.meshInterleukin-4-
dc.subject.meshLiver-
dc.subject.meshMale-
dc.subject.meshNeoplasms-
dc.subject.meshRecombinant Proteins-
dc.subject.meshSleep Stages-
dc.subject.meshTime Factors-
dc.titleRecombinant human interleukin-4 (rhu IL-4) administered by the intravenous and subcutaneous routes in patients with advanced cancer--a phase I toxicity study and pharmacokinetic analysis.en
dc.typeArticleen
dc.contributor.departmentCRC Department of Medical Oncology, Christie Hospital NHS Trust, Manchester, U.K.en
dc.identifier.journalEuropean Journal of Canceren

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