Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Efficacy of continuously delivered intraventricular methotrexate
研究概览
简要总结
This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease
详细描述
PRIMARY OBJECTIVES:
I. Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate infusion in the treatment of leptomeningeal disease.
SECONDARY OBJECTIVES:
I. Describe the dose limiting toxicities. II. Describe the pharmacodynamics of continuously delivered intraventricular methotrexate.
III. Assess for response.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with leptomeningeal carcinomatosis (from solid tumors)
- •Subjects with lymphomatous or leukemic meningitis
- •The effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately
- •Karnofsky Performance Status greater than 70%
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
- •We will exclude subjects who have had prior intrathecal/intraventricular therapy with methotrexate within 6 months
排除标准
- •Prior therapy with methotrexate for management of leptomeningeal disease
- •Subjects with evidence of hydrocephalous
- •Subjects with intraparenchymal lesions or bulky disease
- •Subjects with ventriculoperitoneal shunt in place
- •Previous history of whole brain radiation therapy
- •Subjects who, in the opinion of the principal investigator, may not be able to comply with the safety monitoring requirements of the study will not be included in this trial
研究组 & 干预措施
Treatment (intraventricular chemotherapy)
Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
Treatment (intraventricular chemotherapy)
Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: methotrexate (Drug)
结局指标
主要结局
Efficacy of continuously delivered intraventricular methotrexate
时间窗: Day 3 after start of treatment
The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.
Pharmacokinetics of continuous intraventricular infusion of methotrexate
时间窗: Day 14 after start of treatment
Determined by measuring brain interstitial levels of methotrexate using microdialysis catheters, lumbar cerebral spinal fluid (CSF) levels (a distant site) of methotrexate via a lumbar drain during the inpatients phase, ventricular CSF levels of methotrexate using the Ommaya reservoir, and systemic levels of methotrexate in the blood.
次要结局
- Response rate of continuous intraventricular methotrexate infusion(Day 42 after start of treatment)
- Toxicities of continuous intraventricular methotrexate infusion(Day 3 after start of treatment)
- Pharmacodynamics of continuously delivered intraventricular methotrexate(Day 42 after start of treatment)