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- Title
Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme.
- Authors
Christopher Turner; Susan Chi; Karen Marcus; Tobey MacDonald; Roger Packer; Tina Poussaint; Sridhar Vajapeyam; Nicole Ullrich; Liliana Goumnerova; R. Scott; Caitlin Briody; Christine Chordas; Mary Zimmerman; Mark Kieran
- Abstract
Abstract??A phase II study was conducted to assess the efficacy of administering daily thalidomide concomitantly with radiation and continuing for up to 1?year following radiation in children with brain stem gliomas (BSG) or glioblastoma multiforme (GBM). Secondary objectives were to obtain preliminary evidence of biologic activity of thalidomide and to evaluate toxicities from chronic administration of thalidomide in this population.Thirteen patients (2?14?years old) with newly diagnosed BSG (12 patients) or GBM (one patient) were enrolled between July 1999 and June 2000. All patients received focal radiotherapy to a total dose of 5,580?cGy. Thalidomide was administered once daily beginning on the first day of radiation and continued for 12?months or until the patient came off study. The starting dose was 12?mg/kg (rounded down to the nearest 50?mg) and was increased by 20% weekly, if tolerated, to 24?mg/kg or 1,000?mg (whichever was lower). Advanced imaging techniques and urine and serum analysis for anti-angiogenic markers were performed in some patients in an attempt to correlate changes with clinical effect of therapy.No patients completed the planned 12?months of thalidomide therapy and all have since died of disease progression. The median duration of therapy was 5?months (range 2?11?months). Nine patients came off study for progressive disease (PD), three patients due to toxicity and one patient withdrew consent. Several patients on this study required more extended courses of high dose steroids than would have been otherwise expected for this population due to significant peritumoral edema and necrosis. No consistent pattern emerged from the biologic correlative studies from 11 patients. However, advanced imaging with techniques such as MR spectroscopy, MR perfusion and 18-fluorodeoxyglucose positron emission tomography (FDG-PET) were helpful in distinguishing growing tumor from treatment effect and necrosis in some patients.The median time to progression (TTP) was 5?months (range 2?11?months) and the median time to death (TTD) was 9?months (range 5?17?months). In this small patient sample adding thalidomide to radiation did not improve TTP or TTD from historical controls, however, toxicity appeared to be increased.
- Subjects
GLIOBLASTOMA multiforme; GLIOMAS; THALIDOMIDE; RADIOTHERAPY
- Publication
Journal of Neuro-Oncology, 2007, Vol 82, Issue 1, p95
- ISSN
0167-594X
- Publication type
Article
- DOI
10.1007/s11060-006-9251-9