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Titolo:
A phase I study of CNI-1493, an inhibitor of cytokine release, in combination with high-desk interleukin-2 in patients with renal cancer and melanoma
Autore:
Atkins, HB; Redman, B; Mier, J; Gollob, J; Weber, J; Sosman, J; MacPherson, BL; Plasse, T;
Indirizzi:
Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA Beth Israel Deaconess Med Ctr Boston MA USA 02215 r, Boston, MA 02215 USA Univ Michigan, Med Ctr, Ann Arbor, MI 48109 USA Univ Michigan Ann Arbor MI USA 48109 an, Med Ctr, Ann Arbor, MI 48109 USA Univ So Calif, Kenneth Norris Jr Comprehens Canc Ctr, Los Angeles, CA 90033 USA Univ So Calif Los Angeles CA USA 90033 anc Ctr, Los Angeles, CA 90033 USA Univ Illinois, Med Ctr, Chicago, IL 60612 USA Univ Illinois Chicago IL USA 60612 linois, Med Ctr, Chicago, IL 60612 USA Cytokine PharmaSci Inc, W Conshohocken, PA 19428 USA Cytokine PharmaSci Inc W Conshohocken PA USA 19428 hohocken, PA 19428 USA
Titolo Testata:
CLINICAL CANCER RESEARCH
fascicolo: 3, volume: 7, anno: 2001,
pagine: 486 - 492
SICI:
1078-0432(200103)7:3<486:APISOC>2.0.ZU;2-9
Fonte:
ISI
Lingua:
ENG
Soggetto:
TUMOR-NECROSIS-FACTOR; DOSE RECOMBINANT INTERLEUKIN-2; BLOOD MONONUCLEAR-CELLS; BOLUS INTERLEUKIN-2; THERAPY; CARCINOMA; INDUCTION; TRIAL; IL-2; IMMUNOTHERAPY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
30
Recensione:
Indirizzi per estratti:
Indirizzo: Plasse, T Cytokine PharmaSci Inc, 150 S Warner Rd,Suite 420, King Of Prussia, PA 19406 USA Cytokine PharmaSci Inc 150 S Warner Rd,Suite 420 King Of Prussia PA USA 19406
Citazione:
H.B. Atkins et al., "A phase I study of CNI-1493, an inhibitor of cytokine release, in combination with high-desk interleukin-2 in patients with renal cancer and melanoma", CLIN CANC R, 7(3), 2001, pp. 486-492

Abstract

CNI-1493, an inhibitor of proinflammatory cytokines, was studied in a Phase I trial in melanoma and renal cancer patients receiving high-dose interleukin 2 (IL-2). Objectives of the study were to define the maximum tolerateddose (MTD) and toxicity of CNI-1493, to assess its pharmacological effects, and to define its pharmacokinetics. Twenty-four patients were treated in sequential cohorts with CNI-1493 doses from 2 through 32 mg/m(2) daily. Patients first received only CNI-1493 daily for 5 days. After a 9-day rest, patients received two 5-day courses of IL-2 of 600,000 IU/kg every 8 h for upto 14 doses/course plus daily CNI-1493; courses were separated by a 9-day rest period. CNI-1493 administered alone was well tolerated at doses through 32 mg/m(2); MTD was not reached. The only clinical toxicity attributed toCNI-1493 was occasional injection-site phlebitis, Grade 1 creatinine increases occurred in 1 of 7 patients at 4 mg/m(2), in 1 of 1 patients at 25 mg/m(2), and in 3 of 6 patients at 32 mg/m(2) CNI-1493 alone. In combination with high-dose IL-2, CNI-1493 at greater than or equal to 25 mg/m(2) seemed to exacerbate IL-2-induced nephrotoxicity: grade 3 or 4 creatinine increases developed in 3 of 6 patients at 25 or 32 mg/m(2), as compared with 1 of 16 patients at doses less than or equal to 16 mg/m(2). The MTD for CNI-1493 given with high-dose IL-2 was 16 mg/m(2). The dose-limiting toxicity of IL-2 was hypotension in 63% of patients; overall tolerance to IL-2 was not improved by CNI-1493, However, relative to changes seen in a reference group receiving high-dose IL-2 alone, at doses greater than or equal to4 mg/m(2) CNI-1493 did show evidence of pharmacological activity as an inhibitor of tumor necrosis factor production.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 20/01/20 alle ore 10:15:44