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- Title
A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme.
- Authors
Morris Groves; Vinay Puduvalli; Susan Chang; Charles Conrad; Mark Gilbert; Ivo Tremont-Lukats; Ta-Jen Liu; Pamela Peterson; David Schiff; Timothy Cloughesy; Patrick Wen; Harry Greenberg; Lauren Abrey; Lisa DeAngelis; Kenneth Hess; Kathleen Lamborn; Michael Prados; W. Yung
- Abstract
AbstractBackground??Laboratory and clinical data suggest that the anti-angiogenic agent, thalidomide, if combined with cytotoxic agents, may be effective against recurrent glioblastoma multiforme (GBM).Objectives??To determine 6-month progression-free survival (6PFS) and toxicity of temozolomide plus thalidomide in adults with recurrent GBM.Patients and methods??Eligible patients had recurrent GBM after surgery, radiotherapy, and/or adjuvant chemotherapy. Temozolomide was given at 150?200?mg/m2/day on days 1?5 of each 28-day cycle. Thalidomide was given orally at 400?mg at bedtime (days 1?28) and increased to 1,200?mg as tolerated. Patients were evaluated with magnetic resonance imaging scans every 56?days. The study was designed to detect an increase of the historical 6PFS for GBM from 10 to 30%.Results??Forty-four patients were enrolled, 43 were evaluable for efficacy and safety. The study population included 15 women, 29 men; median age was 53?years (range 32?84); median Karnofsky performance status was 80% (range 60?100%). Thirty-six (82%) patients were chemotherapy-na?ve. There were 57 reports of toxicity of grade 3 or greater. Non-fatal grade 3?4 granulocytopenia occurred in 15 patients (34%). The objective response rate was 7%. The estimated probability of being progression-free at 6?months with this therapy is 24% [95% confidence interval (C.I.) 12?38%]. The median time to progression is 15?weeks (95% C.I. 10?20?weeks). There was no observed correlation between serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and IL-8 and the 6PFS outcome.Conclusion??This drug combination was reasonably safe, but with little indication of improvement compared to temozolomide alone.
- Subjects
TERATOGENIC agents; GLIOBLASTOMA multiforme; THERAPEUTICS; DRUG therapy
- Publication
Journal of Neuro-Oncology, 2007, Vol 81, Issue 3, p271
- ISSN
0167-594X
- Publication type
Article
- DOI
10.1007/s11060-006-9225-y