NCT00112619终止1 期
A Phase I Pharmacokinetic Optimal Dosing Study of Intraventricular Topotecan for Children With Neoplastic Meningitis
Pediatric Brain Tumor Consortium22 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2005年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 22
- 主要终点
- Number of patients with dose-limiting toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of topotecan when given by intraventricular infusion in treating young patients with neoplastic meningitis due to leukemia, lymphoma, or solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of intraventricular topotecan in young patients with neoplastic meningitis secondary to leukemia, lymphoma, or solid tumors.
- Determine the toxic effects and dose-limiting toxicity of this drug in these patients.
- Determine whether the MTD of this drug is also the pharmacokinetic optimal dose, defined by the topotecan lactone concentration in the cerebral spinal fluid (CSF), in these patients.
Secondary
- Determine, preliminarily, the antitumor activity of this drug in these patients.
- Determine the pharmacokinetics of this drug in the CSF of these patients.
- Correlate observed effects of post-treatment central review imaging (if feasible) with response to this drug in these patients.
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:
- •Diagnosis of neoplastic meningitis secondary to leukemia, lymphoma (including AIDS-related lymphoma), or solid tumor (including primary CNS tumors or carcinomas of unknown primary site), defined by 1 of the following criteria:
- •Cerebral spinal fluid (CSF) cell count > 5/μL AND evidence of blast cells on cytospin or by cytology (for patients with leukemia or lymphoma)
- •Presence of tumor cells on cytospin or cytology OR unequivocal presence of meningeal disease by MRI (for patients with solid tumor)
- •No conventional therapy for neoplastic meningitis exists
- •Patients with CNS leukemia or lymphoma must be refractory to conventional therapy, including radiotherapy (i.e., second or greater relapse)
- •Patients with CNS leukemia or lymphoma must have had a negative bone marrow aspiration within the past 2 weeks
- •No clinical evidence of obstructive hydrocephalus
- •No compartmentalization of CSF flow by radioisotope indium In 111 or technetium Tc 99 DTPA flow study
- •No ventriculoperitoneal or ventriculoatrial shunt unless patient is completely shunt-independent
- •No impending spinal cord compression or other CNS involvement (e.g., acute visual loss secondary to optic nerve involvement) requiring emergent local radiotherapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Lansky 60-100% (≤ 16 years of age) OR
- •Karnofsky 60-100% (> 16 years of age)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Calcium ≥ 7 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Sodium 125-150 mmol/L
- •Magnesium ≥ 0.7 mmol/L
- •Must have or be willing to have an intraventricular access device (i.e., Ommaya reservoir)
- •No uncontrolled infection
- •HIV-positive patients with AIDS-related lymphomatous meningitis are eligible
- •No other significant uncontrolled systemic medical illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Recovered from prior biologic therapy or immunotherapy
- •Chemotherapy
- •Recovered from prior chemotherapy
- •At least 1 week since prior intra-colony stimulating factory (CSF) chemotherapy (2 weeks for liposomal cytarabine)
- •At least 3 weeks since prior systemic chemotherapy for leptomeningeal disease
- •Concurrent systemic chemotherapy to control systemic disease or bulk CNS disease allowed provided the systemic chemotherapy is not an investigational agent OR any of the following:
- •High-dose (> 1 g/m^2) methotrexate
- •High-dose (> 1 g/m^2) cytarabine
- •Fluorouracil
- •Capecitabine
- •Nitrosoureas
- •Topotecan
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 8 weeks since prior craniospinal radiotherapy and recovered
- •No concurrent CNS radiotherapy
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Number of patients with dose-limiting toxicity
时间窗: First 14 days of therapy
Estimate the dose of intraventricular topotecan that will result in cerebrospinal fluid lactone concentrations exceeding 1 ng/mL for at least 8 hours after an intrathecal injection
时间窗: Day 1 of Week 1
Estimate the maximum tolerated dose of intraventricular topotecan on this schedule
时间窗: First 14 days of therapy
次要结局
- Number of patients with objective documentation of tumor response to intraventricular topotecan(Weeks 5, 11 and then every 12 weeks until off study)
- Pharmacokinetics(Day 1 of Week 1)
- Correlation of imaging parameters with tumor response(Pre-treatment, week 5, week 11, and then every 12 weeks until off study)
研究者
研究点 (22)
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