Treatment of children with newly diagnosed brain stem gliomas with intravenous recombinant β-interferon and hyperfractionated radiation therapy: A Childrens Cancer Group phase I/II study
✍ Scribed by Roger J. Packer; Michael Prados; Peter Phillips; H. Stacy Nicholson; James M. Boyett; Joel Goldwein; Lucy B. Rorke; Michael N. Needle; Leslie Sutton; Robert A. Zimmerman; Charles R. Fitz; L. Gilbert Vezina; Erlinda Etcubanas; Joy C. Wallenberg; Gregory Reaman; William Wara
- Publisher
- John Wiley and Sons
- Year
- 1996
- Tongue
- English
- Weight
- 721 KB
- Volume
- 77
- Category
- Article
- ISSN
- 0008-543X
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✦ Synopsis
BACKGROUND.
Prognosis for the majority of children with brain stem gliomas is dismal. In previous studies, recombinant beta-interferon (@IF) has been shown to be effective for children with recurrent brain stem gliomas and may also act synergistically with radiotherapy (RT).
METHODS.
Thirty-two children with diffuse intrinsic brain stem gliomas were treated with (rPIF) and 7200 centigray (cGy) of hyperfractionated RT (100 cGy twice-daily fractions) to determine the toxicity of treatment and the tolerance of the brain stem to this regimen, as well as to assess survival. Patients were treated with rpIF 3 times per week during RT and then for 8 weeks following RT. Initially, a dose escalation trial was performed.
RESULTS.
Interferon was initially begun at 12.5 x 10' IUlm' and escalated up to 400 x 10' IU/m'. The safe starting dose was determined to be 100 x lo6 IUIm'. Due to unacceptable toxicity, the maintenance dose was reduced to 200 x lo6 IUI m'. Therapy was relatively well tolerated, although 13 of the patients required dose modifications due to hepatic or hematologic toxicity. Four of the patients had to discontinue treatment due to this toxicity. One patient died while receiving maintenance IF of encephalopathy, seizures, and brain stem dysfunction; believed possibly due to the @IF. Thirty of the 32 patients have developed progressive disease. The median time to progression from study entry was five months and the median time to death was 9 months.
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