carboplatin, temozolomide, and filgrastim in treating patients with newly diagnosed or recurrent high-grade glioma

Conditions: Brain and Central Nervous System Tumors

Summary: 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.

Eligibility criteria:
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

Keywords: adult brain stem glioma adult glioblastoma childhood high-grade cerebral astrocytoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult giant cell glioblastoma adult gliosarcoma