A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma
A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
NOTE: *For patients with diffuse intrinsic pontine glioma only
Patients are followed every 3-6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months.
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed CNS tumor of the following types:
High grade glioma (HGG) of one of the following histologies:
Diffuse intrinsic pontine glioma (DIPG)
Diagnosed by gadolinium-enhanced MRI
At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons
No diffuse leptomeningeal disease
No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:
No diffuse brainstem enlargement due to neurofibromatosis
No primary brain stem malignant glioma
No M+ disease (CSF positive for tumor or metastatic disease)
Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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