NCT00062205已完成2 期
Phase II Trial of Gleevec (STI571) in Therapy of Ewing's Family of Tumors and Desmoplastic Small Round Cell Tumors
City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2002年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Response rate as measured by RECIST criteria
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.
详细描述
OBJECTIVES:
- Determine the effectiveness of imatinib mesylate in patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.
- Determine the toxic effects of this drug in these patients.
- Determine the duration of disease-free and overall survival of patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of Ewing's family of tumors OR desmoplastic small round-cell tumor
- •Must have immunohistochemical evidence of expression of greater than 2+/4+ for either Kit (CD117) or platelet-derived growth factor receptor -a or -b
- •No symptomatic brain metastases
- •Asymptomatic brain metastases are allowed provided patient is not on concurrent anticonvulsants or corticosteroids
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 9 g/dL
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT and SGPT less than 2.5 times ULN
- •No chronic active hepatitis
- •No cirrhosis
- •No other acute or known chronic liver disease
- •Creatinine less than 1.5 times ULN
- •Cardiovascular
- •No concurrent poorly controlled or severe cardiovascular disease
- •No concurrent poorly controlled or severe pulmonary disease
- •HIV negative
- •No concurrent poorly controlled or severe central nervous system disease
- •No other concurrent poorly controlled or severe nonmalignant disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy
- •More than 2 weeks since prior major surgery
- •More than 28 days since prior investigational agents
排除标准
- 未提供
结局指标
主要结局
Response rate as measured by RECIST criteria
次要结局
- Progression-free survival at 6 months
研究者
研究点 (2)
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