Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
 they stop growing or die. Colony-stimulating factors such as filgrastim may increase the
 number of immune cells found in bone marrow or peripheral blood and may help a person's
 immune system recover from the side effects of chemotherapy.

 PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide,
 and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.
OBJECTIVES:

 -  Determine the response rate in patients with newly diagnosed high-grade glioma treated
 with temozolomide, carboplatin, and filgrastim (G-CSF).

 -  Determine the toxicity of this treatment regimen in these patients.

 -  Determine the rate of tumor progression in patients treated with this regimen.

 OUTLINE: This is a multicenter study. Patients are stratified according to disease category
 (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed
 gliomas).

 Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on
 days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7
 and continuing until blood counts recover. Treatment repeats every 28 days for at least 4
 courses in the absence of disease progression or unacceptable toxicity.

 PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this
 study within 4 years.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic
 astrocytoma

 -  Residual tumor on postoperative MRI

 -  Bidimensionally measurable disease

 PATIENT CHARACTERISTICS:

 Age:

 -  Under 65

 Performance status:

 -  Karnofsky or Lansky 70-100% OR

 -  ECOG 0-2

 Life expectancy:

 -  Not specified

 Hematopoietic:

 -  Absolute neutrophil count at least 1,000/mm^3

 -  Hemoglobin at least 8 g/dL (transfusion allowed)

 -  Platelet count greater than 100,000/mm^3

 Hepatic:

 -  Bilirubin less than 1.5 times upper limit of normal (ULN)

 -  SGPT no greater than 3 times ULN

 Renal:

 -  Age 5 years and under: Creatinine less than 1.2 mg/dL

 -  Age over 5 to 10 years: Creatinine less than 1.5 mg/dL

 -  Age over 10 to 15 years: Creatinine less than 1.8 mg/dL

 -  Age over 15 years: Creatinine less than 2.4 mg/dL

 Cardiovascular:

 -  No myocardial infarction within the past 6 months

 Other:

 -  No other concurrent serious medical condition that would preclude study

 -  Able to tolerate oral medications

 -  No prior malignancy for which patient received prior chemotherapy or spinal
 irradiation

 -  No history of severe allergic reaction to platinum-containing compounds

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  At least 72 hours since prior filgrastim (G-CSF)

 Chemotherapy:

 -  No prior chemotherapy

 -  No other concurrent chemotherapy

 Endocrine therapy:

 -  Concurrent steroids for tumor-related cerebral edema allowed

 -  No concurrent corticosteroids for solely antiemetic purposes

 Radiotherapy:

 -  No prior or concurrent radiotherapy

 Surgery:

 -  Recovered from prior surgery

 -  No concurrent surgery