NCT00387400已完成1 期
A Phase I Study of Temozolomide and RAD001C in Patients With Malignant Glioblastoma Multiforme
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 9
- 主要终点
- Safety and tolerability of everolimus as measured by NCI CTCAE v3.0
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with temozolomide in treating patients with newly diagnosed, recurrent, or progressive malignant glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose(s) and the recommended phase II dose(s) of everolimus when administered with standard-dose temozolomide in patients with newly diagnosed, recurrent, or progressive glioblastoma multiforme.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the efficacy of this regimen in patients with measurable disease at baseline.
- Identify correlates of activity by molecular study of paraffin-embedded tumor samples from these patients.
- Determine the pharmacokinetics of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 malignant glioblastoma multiforme, meeting 1 of the following criteria:
- •Newly diagnosed disease AND meets the following criteria:
- •Has undergone prior surgery and radiotherapy with concurrent temozolomide
- •No prior chemotherapy except for concurrent low-dose temozolomide given with radiotherapy
- •Recurrent or progressive disease after front-line therapy AND meets the following criteria:
- •No more than 1 prior chemotherapy regimen in the adjuvant setting
- •More than 4 months since last adjuvant treatment
- •No prior chemotherapy for recurrence
- •Bidimensionally measurable disease, defined as ≥ 1 enhancing lesion ≥ 1 cm x 1 cm by CT scan or MRI, within 21 days of study entry (for patients with recurrent/relapsed disease)
- •Patients receiving steroids must be on stable dose for at least 14 days before baseline CT scan or MRI
- •Paraffin-embedded sample of primary or metastatic tumor diagnostic specimen must be available
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 120,000/mm³
- •Bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatinine normal OR creatinine clearance ≥ 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No upper gastrointestinal condition or other condition that would preclude compliance with oral medication
- •No other prior malignancy except for adequately treated nonmelanoma skin cancer, curatively treated in situ cervical cancer, or other solid tumors curatively treated with no evidence of disease for the past 5 years
- •No serious illness or underlying medical condition that would preclude study compliance, including any of the following:
- •Significant neurologic or psychiatric disorder that would preclude obtaining informed consent
- •Active, ongoing infection
- •No known hypersensitivity to everolimus or temozolomide or their components
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 2 weeks since prior surgery and recovered
- •At least 4 weeks since prior radiotherapy
- •Concurrent enzyme-inducing antiepileptic drugs allowed
- •No concurrent inhibitors of cytochrome 3A4 (e.g., ketoconazole and similar antifungals, erythromycin, or diltiazem)
- •No other concurrent experimental drugs, anticancer treatment, or investigational therapy
- •No concurrent grapefruit juice
排除标准
- 未提供
结局指标
主要结局
Safety and tolerability of everolimus as measured by NCI CTCAE v3.0
时间窗: from the time of the first treatment
次要结局
- Correlation of clinical outcome with pretreatment tumor tissue molecular markers as measured by molecular studies of paraffin-embedded tumor samples(4 years)
- Pharmacokinetics of everolimus during course 1(during course 1)
- Response as measured by CT scan and/or brain MRI at baseline and after every other course and clinical neurologic assessment at baseline and after every course(after every other course)
研究者
研究点 (9)
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