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Titolo:
A phase I clinical, pharmacological, and biological trial of interleukin 6plus granulocyte-colony stimulating factor after ifosfamide, carboplatin, and etoposide in children with recurrent/refractory solid tumors: Enhanced hematological responses but a high incidence of grade III/IV constitutionaltoxicities
Autore:
Bracho, F; Krailo, MD; Shen, V; Bergeron, S; Davenport, V; Liu-Mares, W; Blazar, BR; Panoskaltsis-Mortari, A; van de Ven, C; Secola, R; Ames, MM; Reid, JM; Reaman, GH; Cairo, MS;
Indirizzi:
Georgetown Univ Hosp, Vincent T Lombardi Canc Res Ctr, Washington, DC 20007 USA Georgetown Univ Hosp Washington DC USA 20007 tr, Washington, DC 20007 USA Univ So Calif, Sch Med, Los Angeles, CA 90033 USA Univ So Calif Los Angeles CA USA 90033 Sch Med, Los Angeles, CA 90033 USA Childrens Hosp Orange Cty, Orange, CA 92668 USA Childrens Hosp Orange CtyOrange CA USA 92668 e Cty, Orange, CA 92668 USA Childrens Hosp Los Angeles, Los Angeles, CA 90027 USA Childrens Hosp Los Angeles Los Angeles CA USA 90027 Angeles, CA 90027 USA Univ Minnesota, Ctr Canc, Minneapolis, MN 55455 USA Univ Minnesota Minneapolis MN USA 55455 r Canc, Minneapolis, MN 55455 USA Mayo Clin, Rochester, MN 55905 USA Mayo Clin Rochester MN USA 55905Mayo Clin, Rochester, MN 55905 USA Childrens Natl Med Ctr, Washington, DC 20010 USA Childrens Natl Med Ctr Washington DC USA 20010 , Washington, DC 20010 USA Columbia Univ, Babies & Childrens Hosp, New York, NY 10032 USA Columbia Univ New York NY USA 10032 hildrens Hosp, New York, NY 10032 USA
Titolo Testata:
CLINICAL CANCER RESEARCH
fascicolo: 1, volume: 7, anno: 2001,
pagine: 58 - 67
SICI:
1078-0432(200101)7:1<58:APICPA>2.0.ZU;2-O
Fonte:
ISI
Lingua:
ENG
Soggetto:
RECOMBINANT HUMAN INTERLEUKIN-6; BONE-MARROW; MEGAKARYOCYTE DEVELOPMENT; COMPLEMENTARY-DNA; PROTEIN RESPONSE; BREAST-CANCER; GROWTH-FACTOR; STEM-CELLS; G-CSF; CHEMOTHERAPY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
44
Recensione:
Indirizzi per estratti:
Indirizzo: Cairo, MS Childrens Canc Grp, POB 60012, Arcadia, CA 91066 USA Childrens Canc Grp POB 60012 Arcadia CA USA 91066 , CA 91066 USA
Citazione:
F. Bracho et al., "A phase I clinical, pharmacological, and biological trial of interleukin 6plus granulocyte-colony stimulating factor after ifosfamide, carboplatin, and etoposide in children with recurrent/refractory solid tumors: Enhanced hematological responses but a high incidence of grade III/IV constitutionaltoxicities", CLIN CANC R, 7(1), 2001, pp. 58-67

Abstract

Phase I trial was conducted to determine the safety, biological activity, and hematopoietic recovery by the combination of interleukin 6 (IL-6) and granulocyte-colony stimulating factor (G-CSF) after myelosuppressive chemotherapy in children. Patients <22 years of age at diagnosis with either recurrent or refractory solid tumors received ifosfamide 1,800 mg/m(2)/day x 5 days, carboplatin 400 mg/m(2)/day x 2 days, and etoposide 100 mg/m(2)/day x 5 days, followed by daily s.c. G-CSF (5 <mu>g/kg/day) and IL-6 (2.5, 3.75, or 5.0 mug/kg/day), Pharmacokinetic, proinflammatory mediator levels, hematopoietic colony assays, and cytokine receptor expression studies were performed during course one. Nineteen patients were evaluable for toxicity and received IL-6 at doses of 2.5 (n = 8), 3.75 (n = 5), or 5.0 (n = 6) mug/kg/day. Dose-limiting constitutional toxicity occurred in two of six patients at 5.0 mug/kg/day, two of five patients at 3.75 mug/kg/day, and two of eightpatients at 2.5 mug/kg/day. The maximum tolerated dose (MTD) exceeded the lowest dose tested. Because of lack of drug availability, an MTD was not established. The maximum concentration of IL-6 (2.5 mug/kg/day) was 0.799 +/-1.055 ng/ml (mean +/- SD). During the first course, the median time to absolute neutrophil count greater than or equal to1,000/mm(3) and platelets greater than or equal to 100,000 mm(3) was estimated at 19 and 23 days, respectively. Peripheral blood progenitor cells expressing receptors to IL-3, IL-6, and GCSF increased significantly over baseline (P < 0.05). After the first dose of IL-6, IFN-<gamma> levels were abnormal in 13 patients, and IL-1beta levels were abnormal in 10 patients, IL-6 has a high incidence of constitutional toxicity and a lower MTD in children compared with adults. In vivo use of IL-6 in children after chemotherapy remains limited. However, IL-6 may be more optimally investigated in children under ex vivo conditions.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 07/07/20 alle ore 21:45:22