Low-Dose Chemotherapy in Combination with COX-2 Inhibitors and PPAR-Gamma Agonists in Recurrent High-Grade Gliomas – A Phase II StudyHau P.f · Kunz-Schughart L.a · Bogdahn U.f · Baumgart U.f · Hirschmann B.f · Weimann E.b · Mühleisen H.c · Ruemmele P.d · Steinbrecher A.f · Reichle A.e
aOncoRay/ZIK Dresden, Dresden, bDepartment of Neurology, and cInstitute of Neuropathology, Institute of Pathology, Klinikum Ludwigsburg, Ludwigsburg, dPathology, and eDepartments of Oncology and fNeurology, University of Regensburg, Regensburg, Germany
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Objectives: Combined treatment approaches targeting tumor as well as other cells contributing to tumor progression may control chemorefractory malignancies. Methods: A phase II trial was initiated to analyze the activity of continuously administered pioglitazone and rofecoxib combined with low-dose chemotherapy (capecitabine or temozolomide) in patients with high-grade gliomas (glioblastoma or anaplastic glioma). Results: Fourteen patients were evaluable for response and toxicity. Major side effects were palmoplantar erythema, edema and motor neuropathy grade 3. Disease stabilizations lasting longer than 3 months were noted in 4 of 14 patients (29%). Clinical responses did not correspond to immunohistochemical staining for cyclooxygenase 2, peroxisome proliferator-activated receptor-γ and CD31. Discussion: The study demonstrates that this novel regimen is moderately active and well tolerated in patients with high-grade gliomas. As a comparably small proportion of patients responded, the regimen might only be suitable for a subset of highly selected patients.
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