Phase I clinical trial of cilengitide in children with refractory brain tumors: Pediatric Brain Tumor Consortium Study PBTC-012.

Phase I clinical trial of cilengitide in children with refractory brain tumors: Pediatric Brain Tumor Consortium Study PBTC-012. Research Abstract Details 

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Phase I clinical trial of cilengitide in children with refractory brain tumors: Pediatric Brain Tumor Consortium Study PBTC-012. Abstract Text:

Tobey J MacDonald,Clinton F Stewart,Mehmet Kocak,Stewart Goldman,Richard G Ellenbogen,Peter Phillips,Deborah Lafond,Tina Young Poussaint,Mark W Kieran,James M Boyett,Larry E Kun,

PURPOSE: A phase I trial of the antiangiogenesis agent cilengitide (EMD 121974), an alpha v beta 3,5 integrin antagonist, was performed to estimate the maximum-tolerated dose (MTD) and describe dose-limiting toxicities (DLTs) and the incidence and severity of other toxicities when administered to children with refractory brain tumors. PATIENTS AND METHODS: Thirty-one assessable patients received intravenous cilengitide over 1 hour twice a week for up to 52 weeks at dosages from 120 to 2,400 mg/m(2). Serial blood and urine samples for clinical pharmacology studies were obtained in a subset of consenting patients. RESULTS: No DLTs were observed, and thus, the MTD was not estimated. Three of 13 patients at the dosage level of 2,400 mg/m(2) experienced grade 3 or 4 intratumoral hemorrhage (ITH) possibly related to the study drug; however, two of the ITH events were asymptomatic and, by the current toxicity criteria, would be classified as grade 1. For patients treated at cilengitide 2,400 mg/m(2), the 6-month cumulative incidence estimate of ITH is 23% (SE = 13%). No ITH was observed at 1,800 mg/m(2). Three patients completed 1 year of protocol therapy; one patient with glioblastoma multiforme demonstrated complete response, and two patients had stable disease (SD). An additional patient had SD for more than 5 months. CONCLUSION: The phase II dosage of intravenous cilengitide in children with refractory brain tumors is 1,800 mg/m(2). A phase II trial to assess the efficacy of cilengitide therapy for children with refractory brain tumors is being developed by the Children's Oncology Group.

Phase I clinical trial of cilengitide in children with refractory brain tumors: Pediatric Brain Tumor Consortium Study PBTC-012. Publishing Authors By Initials

TJ MacDonald,CF Stewart,M Kocak,S Goldman,RG Ellenbogen,P Phillips,D Lafond,TY Poussaint,MW Kieran,JM Boyett,LE Kun,

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Phase I clinical trial of cilengitide in children with refractory brain tumors: Pediatric Brain Tumor Consortium Study PBTC-012. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Journal of clinical oncology : official journal of

VOLUME: 26

Page Numbers: 919-24

Journal Abbreviation: J. Clin. Oncol.

ISSN: 1527-7755

DAY: 20

MONTH: Feb

YEAR: 2008

Phase I clinical trial of cilengitide in children with refractory brain tumors: Pediatric Brain Tumor Consortium Study PBTC-012. Information

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LANGUAGE: eng

NlmUniqueID: 8309333

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Grant and Affiliation Information for Phase I clinical trial of cilengitide in children with refractory brain tumors: Pediatric Brain Tumor Consortium Study PBTC-012.

AFFILIATION: Children's National Medical Center, 111 Michigan Ave, NW, Washington, DC 20010, USA. tmacdona@cnmc.org

Country: United States

AGENCY: United States NCI

GRANT: U01 CA81457

ACRONYM: CA

MEDLINETA: J Clin Oncol

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