NCT00389584已完成1 期
Phase I/II Study of Irinotecan and Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall survival (Phase II)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, 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. Irinotecan may make tumor cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when given together with whole-brain radiation therapy and to see how well they work in treating patients with brain metastases from solid tumors. (The study of side effects and best dose has ended as of 4/15/05)
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of irinotecan hydrochloride administered concurrently with whole-brain radiotherapy in patients with brain metastases from solid tumors. (Phase I) (Phase I closed to accrual as of 4/15/05)
- Determine the toxicity of this regimen in these patients. (Phase I) (Phase I closed to accrual as of 4/15/05)
- Determine the overall survival of patients treated with this regimen. (Phase II)
Secondary
- Assess the neurocognitive function of these patients by Mini-Mental Status Examination. (Phase II)
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Year 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of brain metastasis from a histologically confirmed solid tumor, meeting the following criteria:
- •Must have histologic proof of original malignancy
- •No germ cell tumor metastasis
- •Biopsy-proven brain metastasis preferred when clinical history and radiographic findings are equivocal
- •At least 1 unidimensionally measurable lesion ≥ 50 mm by head contrast CT scan and/or brain MRI
- •Patients enrolled in the phase II portion of the study must meet the following Radiation Therapy Oncology Group Recursive Partitioning Analysis staging criteria for brain metastases:
- •Class II classification
- •Zubrod performance status 0-1 AND any of the following:
- •Age > 65 years
- •Extracranial metastasis
- •Uncontrolled primary malignancy
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-1
- •Life expectancy ≥ 3 months
- •Able to participate in the Mini-Mental Status Examination
- •WBC ≥ 3,000/mm³
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 mg/dL
- •AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Hemoglobin ≥ 9.0 g/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No concurrent medical disease that, in the investigator's opinion, would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •More than 21 days since prior chemotherapy
- •No prior whole-brain radiotherapy
- •No prior DNA topoisomerase I drugs (e.g., irinotecan hydrochloride, topotecan hydrochloride)
- •At least 4 days since prior and no concurrent known CYP3A4 inducers, including any of the following:
- •Phenytoin
- •Carbamazepine
- •Phenobarbital
- •Hypericum perforatum (St. John's wort)
排除标准
- 未提供
结局指标
主要结局
Overall survival (Phase II)
Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05)
次要结局
- Neurocognitive deterioration as assessed by Mini-Mental Status Examination (Phase II)
- Time to cognitive failure as assessed by Kaplan-Meier (Phase II)
研究者
研究点 (1)
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