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Titolo:
Phase I pilot trial of the bispecific antibody MDXH210 (anti-Fc gamma RI Xanti-HER-2/neu) in patients whose prostate cancer overexpresses HER-2/neu
Autore:
Schwaab, T; Lewis, LD; Cole, BF; Deo, Y; Fanger, MW; Wallace, P; Guyre, PM; Kaufman, PA; Heaney, JA; Schned, AR; Harris, RD; Ernstoff, MS;
Indirizzi:
Dartmouth Coll, Hitchcock Med Ctr, Urooncol Program, Norris Cotton Canc Ctr, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 otton Canc Ctr, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Urol Sect, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 Ctr, Urol Sect, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Immunol Res Program, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 ol Res Program, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Immunotherapy Res Program, Dept Surg, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 ram, Dept Surg, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Dept Pathol, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 r, Dept Pathol, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Dept Radiol, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 r, Dept Radiol, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Epidemiol & Biostat Sect, Dept Community & Family Med, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 y & Family Med, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Dept Microbiol, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 Dept Microbiol, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Dept Physiol, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 , Dept Physiol, Lebanon, NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Clin Pharmacol Sect, Dept Med, Lebanon,NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 Sect, Dept Med, Lebanon,NH 03756 USA Dartmouth Coll, Hitchcock Med Ctr, Hematol Oncol Sect, Lebanon, NH 03756 USA Dartmouth Coll Lebanon NH USA 03756 tol Oncol Sect, Lebanon, NH 03756 USA Medarex Inc, Annandale, NJ USA Medarex Inc Annandale NJ USAMedarex Inc, Annandale, NJ USA
Titolo Testata:
JOURNAL OF IMMUNOTHERAPY
fascicolo: 1, volume: 24, anno: 2001,
pagine: 79 - 87
SICI:
1524-9557(200101/02)24:1<79:PIPTOT>2.0.ZU;2-G
Fonte:
ISI
Lingua:
ENG
Soggetto:
TUMOR-CELLS; RECEPTOR; CYTOTOXICITY; IGG;
Keywords:
prostate cancer; bispecific antibody; HER-2/neu; treatment;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
18
Recensione:
Indirizzi per estratti:
Indirizzo: Ernstoff, MS Dartmouth Coll, Hitchcock Med Ctr, Hematol Oncol Sect, 1 Med Ctr Dr, Lebanon, NH 03756 USA Dartmouth Coll 1 Med Ctr Dr Lebanon NH USA 03756 NH 03756 USA
Citazione:
T. Schwaab et al., "Phase I pilot trial of the bispecific antibody MDXH210 (anti-Fc gamma RI Xanti-HER-2/neu) in patients whose prostate cancer overexpresses HER-2/neu", J IMMUNOTH, 24(1), 2001, pp. 79-87

Abstract

The goal of this study was to evaluate, in patients with prostate cancer, the toxicity profle acid biologic activity of the bispecific antibody MDXH210, which has specificity for the non-ligand-binding site of the high-affinity immunoglobulin G receptor (Fc gamma RI) and the extracellular. domain of the HER-2/neu photo-oncogene product. Patients with prostate cancer that expressed HER-2/neu were entered into a phase I dose-escalation trial of MDXH210. Patients received an intravenous infusion MDXH210 during a period of2 h three times per week for 2 weeks and were monitored for toxicity. Pharmacokinetic and pharmacodynamic parameters were measured and included the biologic end points of monocyte-bound MDXH210, cytokine production, and clinical response. Seven patients were treated with MDXH210 doses ranging from 1 to 8 mg/m(2). In general, MDXH210 was well tolerated, with only mild infusion-related malaise, fever, chills, and myalgias. No dose-limiting toxic effects were observed. Biologic effects included induction of low plasma concentrations of tumor necrosis factor-alpha and interleukin-6 observed immediately after MDXH210 infusion and 70% saturation of circulating monocyte-associated Fc gamma RT with MDXH210 at a dose level of 4 to 8 mg/m(2). Five of six patients had stable prostate-specific antigen levels during the course of 40 days or more. Circulating plasma HER-2/neu levels decreased by 80% at days 12 and 29 (p = 0.03 and 0.06, respectively, by the Wilcoxon signed rank test). MDXH210 can be given safely to patients with HER-2/neu-positiveprostate cancer in doses of at least 8 mg/m(2). At the doses studied, biologic activity was demonstrated and characterized by binding of MDXH210 to circulating monocytes, release of monocyte-derived cytokines, a decrease in circulating HER-2/neu, and short-term stabilization of prostate-specific antigen levels.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 11/07/20 alle ore 20:07:00