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Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma
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Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma
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Journal Article
Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma
2011
Overview
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.
Publisher
Springer US,Springer Nature B.V
Subject
/ Aged
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Brain Neoplasms - drug therapy
/ Camptothecin - administration & dosage
/ Camptothecin - adverse effects
/ Camptothecin - analogs & derivatives
/ Clinical Study – Patient Study
/ Drugs
/ Female
/ Glioma
/ Humans
/ Indoles - administration & dosage
/ Male
/ Medicine
/ Neoplasm Recurrence, Local - drug therapy
/ Oncology
/ Pyrroles - administration & dosage
/ Survival
/ Toxicity
