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

Publication ,  Journal Article
Reardon, DA; Vredenburgh, JJ; Coan, A; Desjardins, A; Peters, KB; Gururangan, S; Sathornsumetee, S; Rich, JN; Herndon, JE; Friedman, HS
Published in: J Neurooncol
December 2011

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.

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Published In

J Neurooncol

DOI

EISSN

1573-7373

Publication Date

December 2011

Volume

105

Issue

3

Start / End Page

621 / 627

Location

United States

Related Subject Headings

  • Young Adult
  • Sunitinib
  • Pyrroles
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Maximum Tolerated Dose
  • Male
  • Irinotecan
  • Indoles
 

Citation

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Reardon, D. A., Vredenburgh, J. J., Coan, A., Desjardins, A., Peters, K. B., Gururangan, S., … Friedman, H. S. (2011). Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma. J Neurooncol, 105(3), 621–627. https://doi.org/10.1007/s11060-011-0631-4
Reardon, David A., James J. Vredenburgh, April Coan, Annick Desjardins, Katherine B. Peters, Sridharan Gururangan, Sith Sathornsumetee, Jeremy N. Rich, James E. Herndon, and Henry S. Friedman. “Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma.J Neurooncol 105, no. 3 (December 2011): 621–27. https://doi.org/10.1007/s11060-011-0631-4.
Reardon DA, Vredenburgh JJ, Coan A, Desjardins A, Peters KB, Gururangan S, et al. Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma. J Neurooncol. 2011 Dec;105(3):621–7.
Reardon, David A., et al. “Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma.J Neurooncol, vol. 105, no. 3, Dec. 2011, pp. 621–27. Pubmed, doi:10.1007/s11060-011-0631-4.
Reardon DA, Vredenburgh JJ, Coan A, Desjardins A, Peters KB, Gururangan S, Sathornsumetee S, Rich JN, Herndon JE, Friedman HS. Phase I study of sunitinib and irinotecan for patients with recurrent malignant glioma. J Neurooncol. 2011 Dec;105(3):621–627.
Journal cover image

Published In

J Neurooncol

DOI

EISSN

1573-7373

Publication Date

December 2011

Volume

105

Issue

3

Start / End Page

621 / 627

Location

United States

Related Subject Headings

  • Young Adult
  • Sunitinib
  • Pyrroles
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Maximum Tolerated Dose
  • Male
  • Irinotecan
  • Indoles