NCT00082797已完成2 期
A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 130
- 主要终点
- Response rate (complete and partial)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Leucovorin may decrease side effects caused by high-dose methotrexate.
PURPOSE: This phase II trial is studying how well giving high-dose methotrexate together with leucovorin works in treating patients with newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the response in patients with newly diagnosed glioblastoma multiforme treated with high-dose methotrexate and leucovorin calcium.
Secondary
- Determine the acute toxicity of this regimen in these patients.
- Determine the duration of survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed glioblastoma multiforme (GBM)
- •Supratentorial grade IV disease
- •Measurable and contrast-enhancing disease ≥ 1 cm by CT scan or MRI
- •No radiographic evidence of ascites or pleural effusion
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •SGOT ≤ 4.0 times upper limit of normal
- •Bilirubin ≤ 2.0 mg/dL
- •Creatinine ≤ 2.0 mg/dL
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •No uncontrolled hypertension
- •No unstable angina
- •No symptomatic congestive heart failure
- •No uncontrolled cardiac arrhythmia
- •No myocardial infarction within the past 6 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to achieve hydration
- •No diabetes insipidus
- •No known hypersensitivity to methotrexate or leucovorin calcium
- •No concurrent serious infection or medical illness that would preclude study participation
- •No other malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior immunotherapy for GBM
- •No prior administration of any of the following biologic agents for GBM:
- •Immunotoxins
- •Immunoconjugates
- •Antisense therapy
- •Peptide receptor antagonists
- •Interferons
- •Interleukins
- •Tumor-infiltrating lymphocytes
- •Lymphokine-activated killer cells
- •Gene therapy
- •No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- •Chemotherapy
- •No prior chemotherapy for GBM
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Prior glucocorticoid therapy allowed
- 另有 12 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate (complete and partial)
次要结局
- Frequency of toxicity
研究者
研究点 (130)
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