NCT00025311已完成1 期
A Phase I Study Of Seven Day Continuous Intrathecal/Intraventricular Infusion Of Topotecan For Patients With Recurrent, Progressive Or Refractory Leptomingeal Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of intrathecal or intraventricular topotecan in patients with recurrent, progressive, or refractory leptomeningeal disease.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (leukemia or lymphoma vs solid tumor or other malignancy).
Patients receive topotecan intrathecally or intraventricularly continuously on days 1-7. Treatment repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose- limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologic or tumor marker confirmation of malignancy at original diagnosis
- •Neoplastic meningitis/leptomeningeal metastasis refractory to conventional therapy and other therapies of higher priority, defined as:
- •Stratum A:
- •Small non-cleaved lymphoma (Burkitt's) with any L-3 blast in cerebrospinal fluid (CSF)
- •Any other lymphoma or leukemia with CSF cell count greater than 5/mm3 AND evidence of blast cells by cytology or cytospin preparation OR
- •Stratum B:
- •Solid tumor or other malignancy with presence of tumor cells on cytospin OR positive cytology OR neuroimaging evidence of leptomeningeal tumor by MRI or CT myelogram
- •No leptomeningeal leukemia or lymphoma with concurrent bone marrow relapse
- •No clinical evidence of untreated obstructive hydrocephalus or compartmentalization of the CSF
- •PATIENT CHARACTERISTICS:
- •65 and under
- •Performance status:
- •Lansky 50-100% (age 16 and under)
- •Karnofsky 50-100% OR ECOG 0-3 (over age 16)
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •Stratum B:
- •Absolute neutrophil count at least 750/mm^3
- •Platelet count at least 75,000/mm^3 (transfusion independent)
- •Hemoglobin at least 10.0 g/dL (red blood cell transfusions allowed)
- •Bilirubin no greater than 1.5 times normal
- •SGOT or SGPT less than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- •Neurologic:
- •Seizures allowed if well controlled and on anticonvulsants
- •CNS toxicity no greater than grade 2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled infections
- •HIV allowed
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunomodulating agents (stratum B)
- •No stem cell transplantation (stratum A)
- •Chemotherapy:
- •At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas)
- •No other concurrent cancer chemotherapy (stratum B)
- •Other concurrent systemic cancer chemotherapy for leukemia or lymphoma allowed with the following restrictions:
- •No oral or IV topotecan
- •No moderate or high-dose IV or subcutaneous cytarabine (greater than 1.0 g/m2 per day)
- •No moderate or high-dose IV methotrexate (greater than 1 g/m2 per day)
- •No IV thiotepa
- •No myeloablative chemotherapy
- •No intrathecal or intraventricular chemotherapy
- •Endocrine therapy:
- •Concurrent corticosteroids allowed only for treatment of increased intracranial pressure in patients with CNS tumors
- 另有 9 项未显示
排除标准
- 未提供
研究者
研究点 (6)
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