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.
- 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
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.
- Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic
- Residual tumor on postoperative MRI
- Bidimensionally measurable disease
- Under 65
- Karnofsky or Lansky 70-100% OR
- ECOG 0-2
- Not specified
- 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
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGPT no greater than 3 times ULN
- 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
- No myocardial infarction within the past 6 months
- 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
- 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:
- At least 72 hours since prior filgrastim (G-CSF)
- No prior chemotherapy
- No other concurrent chemotherapy
- Concurrent steroids for tumor-related cerebral edema allowed
- No concurrent corticosteroids for solely antiemetic purposes
- No prior or concurrent radiotherapy
- Recovered from prior surgery
- No concurrent surgery