NCT00083096Unknown1 期
Phase I Study Of SCH66336 (Lonafarnib), A Farnesyl Protein Transferase Inhibitor In Combination With Temozolomide In Gliomas
European Organisation for Research and Treatment of Cancer - EORTC3 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2004年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Dose-limiting toxicity and maximum tolerated dose of lonafarnib determined by CTCAE v3.0
研究概览
简要总结
RATIONALE: Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving lonafarnib together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with temozolomide in treating patients with recurrent primary supratentorial glioma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of lonafarnib when administered with temozolomide in patients with recurrent primary supratentorial gliomas.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the mechanism of action of lonafarnib in these patients.
- Determine the pharmacodynamics and pharmacokinetics of this regimen in these patients.
- Determine the activity of this regimen in these patients.
- Determine the response to this regimen in patients who have measurable disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary supratentorial glioma
- •Multifocal disease allowed
- •Recurrent disease after prior surgery and/or radiotherapy
- •Radiological evidence of increased and/or enhanced target lesion
- •Amenable to temozolomide therapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 OR
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10.0 g/dL
- •Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
- •Transaminases < 2.5 times ULN
- •Bilirubin < 1.5 times ULN
- •Creatinine < 1.7 mg/dL
- •Cardiovascular
- •Cardiac function clinically normal
- •Normal 12-lead ECG
- •QTc ≤ 440 msec on ECG
- •No ischemic heart disease within the past 6 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No unstable systemic disease
- •No active uncontrolled infection
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •No other active or recurrent malignancy within the past 5 years except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent anticancer biologic agents
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy (6 weeks for temozolomide)
- •Prior adjuvant chemotherapy allowed
- •No more than 1 prior chemotherapy regimen for recurrent disease
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Concurrent corticosteroids allowed provided treatment remains at a stable or decreasing dose for at least 2 weeks
- •Radiotherapy
- •See Disease Characteristics
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 3 months since prior surgery for primary brain tumor
- •Concurrent anticonvulsants allowed
- •No other concurrent anticancer agents
- •No other concurrent investigational therapy
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity and maximum tolerated dose of lonafarnib determined by CTCAE v3.0
次要结局
- Response (complete [CR] or partial response [PR]) measured by McDonald's criteria at least 4 weeks after first documented response and every 8 weeks until disease progression or until start of another treatment
研究者
研究点 (3)
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