EUCTR2004-005164-25-DK进行中（未招募）1 期
Phase II study of thalidomide in combination with temozolomide in metastatic malignant melanoma with brain metastases - Tem-Thal
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Biopsy verified malignant melanoma
- •- Performance status =2
- •- Expected lifetime of =3 months
- •- Age =18 years
- •- Written and oral informed consent according to the Ethical Committees
- •- Participation in Pharmions Risk Management Program
- •- Progressive brain metastases (not requireing treatment with steroids)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- White Blood Cell count (WBC) <3.5 x 109/l
- •- Neutrophils <1.5 x 109/l
- •- Platelets <100 x 109/l
- •- ALAT >2.5 x Upper Normal Limit (UNL)
- •- ALP >2.5 x UNL
- •- Bilirubin >1.5 x UNL
- •- Creatinine >1.5 x UNL
- •- Pregnant or breast feeding women
- •- Women of childbearing potential must use safe anticontraception and men must ensure that they use condom
- •- Prior treatment with IL-2 or progression after/during treatment with IL-2
- •- Patients having received any other experimental or anti-cancer therapy within 4 weeks before study drug administration
- •- Any medical condition that might be aggravated by treatment or which could not be controlled
研究者
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