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Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma.


Posted on: 07/12/2011

J Neurooncol. 2011 Jul 9. [Epub ahead of print]

Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma.

Reardon DA, Vredenburgh JJ, Coan A, Desjardins A, Peters KB, Gururangan S, Sathornsumetee S, Rich JN, Herndon JE, Friedman HS.

Source

Department of Pediatrics, Duke University Medical Center, Durham, NC, USA, reard003@mc.duke.edu.

Abstract

We determined the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of the oral vascular endothelial growth factor receptor (VEGFR) inhibitor, sunitinib, when administered with irinotecan among recurrent malignant glioma (MG) patients. For each 42-day cycle, sunitinib was administered once a day for four consecutive weeks followed by a 2 week rest. Irinotecan was administered intravenously every other week. Each agent was alternatively escalated among cohorts of 3-6 patients enrolled at each dose level. Patients on CYP3A-inducing anti-epileptic drugs were not eligible. Twenty-five patients with recurrent MG were enrolled, including 15 (60%) with glioblastoma (GBM) and 10 (40%) with grade 3 MG. Five patients progressed previously on bevacizumab and two had received prior VEGFR tyrosine kinase inhibitor therapy. The MTD was 50 mg of sunitinib combined with 75 mg/m(2) of irinotecan. DLT were primarily hematologic and included grade 4 neutropenia in 3 patients and one patient with grade 4 thrombocytopenia. Non-hematologic DLT included grade 3 mucositis (n = 1) and grade 3 dehydration (n = 1). Progression-free survival (PFS)-6 was 24% and only one patient achieved a radiographic response. The combination of sunitinib and irinotecan was associated with moderate toxicity and limited anti-tumor activity. Further studies with this regimen using the dosing schedules evaluated in this study are not warranted.

 

PMID: 21744079 [PubMed - as supplied by publisher]

 


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