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Titolo:
PHASE-I TRIAL OF INTERLEUKIN-2 IN COMBINATION WITH THE SOLUBLE TUMOR-NECROSIS-FACTOR RECEPTOR P75 IGG CHIMERA
Autore:
TREHU EG; MIER JW; DUBOIS JS; SORCE D; KLEMPNER MS; EPSTEIN M; DINARELLO CA; SHAPIRO L; KAPPLER K; RONAYNE L; ATKINS MB;
Indirizzi:
TUFTS UNIV,NEW ENGLAND MED CTR,DIV ADULT HEMATOL ONCOL,750 WASHINGTONST,BOX 542 BOSTON MA 02111 TUFTS UNIV,SCH MED,DIV HEMATOL ONCOL BOSTON MA 02111 TUFTS UNIV,SCH MED,DIV INFECT DIS BOSTON MA 02111 TUFTS UNIV NEW ENGLAND MED CTR BOSTON MA 02111
Titolo Testata:
Clinical cancer research
fascicolo: 8, volume: 2, anno: 1996,
pagine: 1341 - 1351
SICI:
1078-0432(1996)2:8<1341:PTOIIC>2.0.ZU;2-#
Fonte:
ISI
Lingua:
ENG
Soggetto:
ACTIVATED KILLER-CELLS; BLOOD MONONUCLEAR-CELLS; METASTATIC MALIGNANT-MELANOMA; HIGH-DOSE INTERLEUKIN-2; METHYL-L-ARGININE; CONTINUOUS INFUSION INTERLEUKIN-2; NITRIC-OXIDE SYNTHESIS; RECOMBINANT INTERLEUKIN-2; FACTOR-ALPHA; FACTOR TNF;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
53
Recensione:
Indirizzi per estratti:
Citazione:
E.G. Trehu et al., "PHASE-I TRIAL OF INTERLEUKIN-2 IN COMBINATION WITH THE SOLUBLE TUMOR-NECROSIS-FACTOR RECEPTOR P75 IGG CHIMERA", Clinical cancer research, 2(8), 1996, pp. 1341-1351

Abstract

Our purpose was to determine the effective biological dose and/or maximum tolerated dose of recombinant human tumor necrosis factor receptor:IgG chimera (rhuTNFR:Fc; Immunex, Seattle, WA) in combination with interleukin 2 (IL-2) with regard to reduction in IL-2 toxicity and modulation of biological effects of high-dose IL-2 administration, Twenty-four patients with metastatic cancer were treated with escalating doses of rhuTNFR:Fc at 1, 1, 5, 10, and 20 mg/m(2) i,v, on days 1 and 15 (dose levels 1-5) or 10, 20, and 30 mg/m(2) days 1 and 15 plus 50% doseon days 3, 5, 17, and 19 (dose levels 6-8) prior to IL 2 at doses of 300,000 IU/kg (dose level 1) and 600,000 IU/kg (dose levels 2-8) i,v, every 8 h on days 1-5 and 15-19, The t(1/2) of rhuTNFR in patients receiving IL-2 was 72 h, The median number of IL-2 doses was 24, and central nervous system, skin, and cardiac arrhythmias were the major dose-limiting toxicities. TNF bioactivity was inhibited, and the polymorphonuclear leukocyte chemotactic defect normally seen with IL-2 was not observed, Increases in C-reactive protein, IL-6, IL-8, and IL-1 receptor antagonist levels were partially suppressed relative to historical controls, whereas peripheral blood mononuclear cell phenotypes, urinarynitrate, endothelial adhesion molecule expression in skin biopsies, and cellular infiltrates in tumor biopsies were consistent with findings in patients treated with IL-2 alone, Four patients developed thyroiddysfunction, There were five responses: two complete responses (both melanoma) and three partial responses (response rate, 21%), rhuTNFR:Fcmay modulate the toxicity and some of the biological effects of IL-2 while preserving antitumor activity, Dose level 6 (10 mg/m(2) on days 1 and 15, and 5 mg/m(2) on days 3, 5, 17, and 19) has been chosen for a randomized, double-blind, placebo-controlled trial of IL-2 with and without rhuTNFR:Fc.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/11/20 alle ore 10:28:00