Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic astrocytoma
- •Residual tumor on postoperative MRI
- •Bidimensionally measurable disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky or Lansky 70-100% OR
- •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
- •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
- •Cardiovascular:
- •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 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
- •Recovered from prior surgery
- •No concurrent surgery
排除标准
- 未提供