Brain and Central Nervous System Tumors
Conditions
Keywords
adult brain stem glioma, adult glioblastoma, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALfilgrastim
DRUGcarboplatin
DRUGtemozolomide
Sponsors
National Cancer Institute (NCI)
NYU Langone Health
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
No minimum to 64 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed