Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.
研究概览
简要总结
This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.
详细描述
Thymic carcinomas are particularly more concerning due to their aggressive metastatic nature and shorter overall survival, in comparison to their lesser-malignant thymoma counterparts. This necessitates the need for systemic therapy. Due to the paucity of thymic carcinoma cases, the ideal regimen for locally advanced or metastatic thymic carcinomas is not defined.To this point, there has not been a study using imatinib in thymic tumors expressing the KIT tyrosine kinase protein or PDGF tyrosine kinase protein. This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histological or cytological proof of advanced C-KIT positive or PDGFR positive thymic carcinoma. For protocol purposes, advanced disease is defined as disease
- •Patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
- •No prior imatinib therapy.
- •Age > 18 years at the time of consent
- •ECOG performance status of 0 or 1
- •ANC ≥ 1500/mm3,Platelet count ≥ 100,000/mm,Total bilirubin < 1.5ULN,3.10 Serum creatinine ≤ 1.7 mg/dl,ALT and AST ≤ 3 x ULN
排除标准
- •Clinically significant infections as judged by the treating investigator
- •Clinically significant concurrent illnesses
- •Females of childbearing potential not using birth control or breastfeeding
- •Prior radiation therapy > 25% of the bone marrow
- •Symptomatic brain metastasis
- •History of Grade III/IV cardiac problems
- •History of major surgery within 14 days prior to being registered
- •Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
结局指标
主要结局
To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.
时间窗: baseline through progression
To determine the duration of remission of patients with thymic carcinoma treated with imatinib.
时间窗: baseline through progression
To determine the toxicity of imatinib in this patient population.
时间窗: baseline through end of study
To determine the incidence of kit mutations in thymic malignancies.
时间窗: baseline
次要结局
未报告次要终点