NCT00357253已完成1 期
A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas
Pediatric Brain Tumor Consortium24 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 24
- 主要终点
- Maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) in combination with radiotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to radiation therapy. Giving capecitabine together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating young patients with newly diagnosed, nonmetastatic brain stem glioma or high-grade glioma.
详细描述
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) administered concurrently with radiotherapy in young patients with newly diagnosed, nondisseminated intrinsic brain stem glioma or high-grade glioma.
- Describe the dose-limiting toxicity in patients treated with this regimen.
Secondary
- Describe the safety profile of this regimen.
- Characterize the pharmacokinetics of capecitabine RDT in these patients.
- Explore the exposure-response relationship for measures of safety and effectiveness using pharmacokinetic and pharmacodynamic models.
- Describe the antitumor activity of this regimen observed in these patients.
- Estimate distributions of progression-free survival and survival in patients treated with this regimen.
- Characterize radiographic changes in tumor, using MRI, perfusion and diffusion MRI, and positron emission tomography (PET) scans, in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •One of the following newly diagnosed, nondisseminated brain tumors:
- •Intrinsic infiltrating brain stem glioma
- •Histopathologic diagnosis not required
- •Histopathologically confirmed high-grade glioma, meeting all of the following criteria:
- •Underwent prior definitive surgery ≤ 28 days ago with incompletely resected disease
- •Any of the following subtypes allowed:
- •Anaplastic astrocytoma
- •Glioblastoma multiforme
- •Other high-grade glioma
- •No anaplastic oligodendroglioma
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance scale (PS) 50-100% (if > 16 years of age) or Lansky PS 50-100% (if ≤ 16 years of age)
- •Absolute neutrophil count ≥ 1,000/mm³
- •Platelet count ≥ 100,000/mm³ (transfusion independent)
- •Hemoglobin ≥ 8 g/dL (transfusion independent)
- •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age as follows:
- •No more than 0.8 mg/dL (for patients 5 years of age and under)
- •No more than 1 mg/dL (for patients 6-10 years of age)
- •No more than 1.2 mg/dL (for patients 11-15 years of age)
- •No more than 1.5 mg/dL (for patients over 15 years of age)
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT ≤ 5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled infection
- •No significant cardiac, hepatic, gastrointestinal, renal, pulmonary, or other systemic disease
- •No known hypersensitivity to capecitabine or any of its components
- •No known dihydropyrimidine dehydrogenase (DPD) deficiency
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior dexamethasone and/or surgery allowed
- •No prior chemotherapy, radiotherapy, immunotherapy, or bone marrow transplantation
- •No other concurrent anticancer or experimental drug therapies or agents
- •No concurrent warfarin or sorivudine or its chemically related analogues (e.g., brivudine)
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) in combination with radiotherapy
时间窗: First 11 weeks of therapy
Dose-limiting toxicity
时间窗: First 11 weeks of therapy
次要结局
- Tumor response(From day 1 of treatment until off study)
- Survival(From initiation of treatment until death or off study)
- Radiographic changes in gliomas as measured by MRI, magnetic resonance spectroscopy (MRS), perfusion and diffusion MRI(Baseline, week 11, then every 3 months for 2 years or until off study)
- Pharmacokinetics of capecitabine RDT measured periodically during course 1(Day 1 and Day 14 of therapy)
研究者
研究点 (24)
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