RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas.
A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma
OUTLINE: This is a pilot, multicenter study.
Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study within 1-1.5 years.
Brain Tumors Central Nervous System Tumors childhood high-grade cerebral astrocytoma childhood spinal cord neoplasm Temozolomide Dacarbazine Lomustine
For people ages 3 years to 21 years
3 to 21
Lansky 50-100% (for patients ≤ 16 years of age)
At least 8 weeks
Hemoglobin ≥ 8 g/dL (transfusions allowed)
Albumin ≥ 2 g/dL
Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal
Pulse oximetry ≥ 94% (if determination is clinically indicated)
PRIOR CONCURRENT THERAPY:
No prior biologic agents
No prior chemotherapy
Concurrent corticosteroids allowed only for treatment of increased intracranial pressure
No concurrent radiotherapy using cobalt-60
See Disease Characteristics
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