A phase I study of rDNA alpha-2b interferon as a 6-week continuous intravenous infusion.

2.50
Hdl Handle:
http://hdl.handle.net/10541/108004
Title:
A phase I study of rDNA alpha-2b interferon as a 6-week continuous intravenous infusion.
Authors:
Smith, David B; Wagstaff, John; Thatcher, Nick; Scarffe, J Howard
Abstract:
Sixteen patients with advanced malignancy were treated with rDNA alpha-2b interferon using a continuous 6-week i.v. schedule. Patients received 1 microgram, 3 mu [corrected], 5 mu and 7 mu/m2/day via a portable infusion pump system, all therapy being on an outpatient basis. The dose-limiting toxicity occurring at 7 mu/m2/day [corrected] was lethargy and somnolence. Five million units (mu) was the maximum tolerated dose but significant nausea, anorexia and lethargy affected 4/5 patients at this level. A dose of 3 mu/m2/day was well tolerated, producing little disturbance of normal activity in the majority of patients. Suppression of WBC and platelets was seen at all doses but was not dose-limiting. There was increasing severity of derangement of hepatic transaminases with increasing dose, and the occurrence of liver toxicity appeared to correlate with nausea, anorexia and lethargy. Assay of serum interferon during the infusion showed that this system maintained a constant level of interferon in the blood. However, the increase did not show a linear pattern with increasing dose, suggesting saturation of metabolic inactivation at 7 mu/m2/day. We recommend that a dose of 3 mu/m2/day be used in future studies of prolonged infusions of alpha-2 interferon.
Affiliation:
Cancer Research Campaign Department of Medical Oncology, Christie Hospital and Holt Radium Institute, Manchester, UK.
Citation:
A phase I study of rDNA alpha-2b interferon as a 6-week continuous intravenous infusion. 1987, 20 (4):327-31 Cancer Chemother. Pharmacol.
Journal:
Cancer Chemotherapy and Pharmacology
Issue Date:
1987
URI:
http://hdl.handle.net/10541/108004
DOI:
10.1007/BF00262586
PubMed ID:
3690806
Type:
Article
Language:
en
ISSN:
0344-5704
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorSmith, David Ben
dc.contributor.authorWagstaff, Johnen
dc.contributor.authorThatcher, Nicken
dc.contributor.authorScarffe, J Howarden
dc.date.accessioned2010-07-21T09:56:13Z-
dc.date.available2010-07-21T09:56:13Z-
dc.date.issued1987-
dc.identifier.citationA phase I study of rDNA alpha-2b interferon as a 6-week continuous intravenous infusion. 1987, 20 (4):327-31 Cancer Chemother. Pharmacol.en
dc.identifier.issn0344-5704-
dc.identifier.pmid3690806-
dc.identifier.doi10.1007/BF00262586-
dc.identifier.urihttp://hdl.handle.net/10541/108004-
dc.description.abstractSixteen patients with advanced malignancy were treated with rDNA alpha-2b interferon using a continuous 6-week i.v. schedule. Patients received 1 microgram, 3 mu [corrected], 5 mu and 7 mu/m2/day via a portable infusion pump system, all therapy being on an outpatient basis. The dose-limiting toxicity occurring at 7 mu/m2/day [corrected] was lethargy and somnolence. Five million units (mu) was the maximum tolerated dose but significant nausea, anorexia and lethargy affected 4/5 patients at this level. A dose of 3 mu/m2/day was well tolerated, producing little disturbance of normal activity in the majority of patients. Suppression of WBC and platelets was seen at all doses but was not dose-limiting. There was increasing severity of derangement of hepatic transaminases with increasing dose, and the occurrence of liver toxicity appeared to correlate with nausea, anorexia and lethargy. Assay of serum interferon during the infusion showed that this system maintained a constant level of interferon in the blood. However, the increase did not show a linear pattern with increasing dose, suggesting saturation of metabolic inactivation at 7 mu/m2/day. We recommend that a dose of 3 mu/m2/day be used in future studies of prolonged infusions of alpha-2 interferon.en
dc.language.isoenen
dc.subjectHaematologic Diseasesen
dc.subject.meshAdult-
dc.subject.meshAnorexia-
dc.subject.meshDrug Evaluation-
dc.subject.meshDrug-Induced Liver Injury-
dc.subject.meshHematologic Diseases-
dc.subject.meshHumans-
dc.subject.meshInfusions, Intravenous-
dc.subject.meshInterferon Type I-
dc.subject.meshMelanoma-
dc.subject.meshMiddle Aged-
dc.subject.meshMultiple Myeloma-
dc.subject.meshNausea-
dc.subject.meshRecombinant Proteins-
dc.titleA phase I study of rDNA alpha-2b interferon as a 6-week continuous intravenous infusion.en
dc.typeArticleen
dc.contributor.departmentCancer Research Campaign Department of Medical Oncology, Christie Hospital and Holt Radium Institute, Manchester, UK.en
dc.identifier.journalCancer Chemotherapy and Pharmacologyen

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