Phase I Study of Intrathecal Topotecan
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy).
详细描述
The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). A safe dose of topotecan that can be recommended for intrathecal administration in subsequent phase II studies will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal topotecan will also be studied. Topotecan will be administered intrathecally on a bi-weekly basis for four to six weeks, followed by weekly administration for 1 month, twice monthly administration for four months and then monthly IT administration.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Leukemia, lymphoma, or solid tumor with overt meningeal involvement considered refractory to conventional therapy.
- •CSF leukemic cell count at least 5 per cubic millimeter with evidence of blast cells on cytospin or cytology required for leukemia and lymphoma patients.
- •Tumor cells on cytospin or cytology or measurable meningeal disease on CT or MRI required for patients with solid tumors.
- •No clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by indium-111- or technetium-99-DPTA flow study.
- •PRIOR/CONCURRENT THERAPY:
- •At least 1 week since CNS therapy.
- •Biologic Therapy: Recovery from toxic effects of prior immunotherapy required.
- •Chemotherapy:
- •Recovery from toxic effects of prior chemotherapy required.
- •No concomitant therapy to treat meningeal malignancy (intrathecal or systemic).
- •Concomitant chemotherapy to control systemic disease or bulk CNS disease allowed except: Investigational agents. Agents that penetrate the CNS (e.g., high-dose methotrexate, thiotepa, high-dose cytarabine, fluorouracil, intravenous mercaptopurine).
- •Agents known to have serious unpredictable CNS side effects.
- •Endocrine Therapy: Not specified.
- •Radiotherapy: Recovery from toxic effects of prior radiotherapy required. Patient eligible if flow restored following focal radiotherapy to the blockage site.
- •Surgery: Not specified.
- •PATIENT CHARACTERISTICS:
- •Age: 3 and over (older patients giving consent will be enrolled before the very young, if possible).
- •Performance status: ECOG 0-
- •Life expectancy: At least 8 weeks.
- •Hematopoietic: See Disease Characteristics.
- •Hepatic: Bilirubin less than 2.0 mg/dL, SGPT less than 3 times normal.
- •Renal: Creatinine less than 1.5 mg/dL.
- •Metabolic: Serum electrolytes (including calcium and phosphate) normal.
- •Other: No significant systemic illness (e.g., infection). Not pregnant or lactating.
排除标准
- 未提供