Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Biological: filgrastim
* Drug: carboplatin
* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: carboplatin|nan|
|Drug: temozolomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult brain stem glioma, adult glioblastoma, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma