A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following
histologies:

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Gliosarcoma

- Primary spinal cord malignant gliomas allowed

- No primary brainstem tumors

- Has undergone surgical resection or biopsy of the tumor within the past 31 days

- Pre-operative and post-operative brain MRI with and without gadolinium-contrast
OR pre-operative and post-operative spine MRI for spinal cord primaries

- Post-operative MRI not required for patients who undergo biopsy only

- No evidence of neuraxis dissemination

- Spine MRI and cerebrospinal fluid cytology required only if clinically indicated

PATIENT CHARACTERISTICS:

Age

- 3 to 21

Performance status

- Karnofsky 50-100% (for patients > 16 years of age)

- Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

- At least 8 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3 (transfusion independent)

- Hemoglobin ≥ 8 g/dL (transfusions allowed)

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT ≤ 2.5 times ULN

- Albumin ≥ 2 g/dL

Renal

- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of
normal

Pulmonary

- No evidence of dyspnea at rest

- No exercise intolerance

- Pulse oximetry ≥ 94% (if determination is clinically indicated)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

- Able to swallow oral medication

- Seizures allowed provided they are well controlled with anticonvulsants

- No hypersensitivity to temozolomide

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic agents

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior corticosteroids allowed

- No concurrent corticosteroids as an antiemetic

- Concurrent corticosteroids allowed only for treatment of increased intracranial
pressure

Radiotherapy

- No concurrent radiotherapy using cobalt-60

Surgery

- See Disease Characteristics

Other

- No other prior treatment

- No concurrent phenobarbital or cimetidine

- No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during
study chemoradiotherapy