NCT00667953终止1 期
Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety - Grade 3 or 4 Adverse Events
研究概览
简要总结
This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.
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
- •Histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- •Prior chemotherapy, immunotherapy, radiation therapy (Phase I portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide
- •Measurable disease
- •Performance status <= 2
- •Life expectancy greater than 3 months
排除标准
- •No prior treatment with temozolomide or imatinib mesylate
- •Organ allografts
- •Prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area
- •Pregnancy or lactation
- •History of second cancer
- •Known hypersensitivity to temozolomide or imatinib
- •Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment
研究组 & 干预措施
Arm A:
Experimental
Temozolomide plus imatinib
干预措施: Gleevec (Drug)
Arm A:
Experimental
Temozolomide plus imatinib
干预措施: Temodar (Drug)
结局指标
主要结局
Safety - Grade 3 or 4 Adverse Events
时间窗: through study completion, an average of 1 year
Number of reported grade 3 or 4 adverse events
次要结局
- Response(through study completion, an average of 1 year)
- To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide(through study completion)
研究者
研究点 (1)
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