Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent
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.
;
Primary Purpose: Treatment
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