EUCTR2004-005166-20-DK进行中（未招募）1 期
Phase II study of first-line therapy with Thalidomide in combination with Peg-introna and decrescendo IL-2 in patients with metastatic malignant melanoma - Decrescendo
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 metastatic malignant melanoma in progression
- •- At least one measurable lesion using the RECIST criteria
- •- Age =18 and = 70 years
- •- Performance status WHO 0-2
- •- Adequate bone marrow, renal and hepatic function
- •- Written and oral informed consent according to the Ethical Committees
- •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
- •- Prior treatment with IL-2
- •- Pregnant or breastfeeding women
- •- Male or female patients with reproductive potential must use an approved contraceptive method during and for 3 months after the end of study treatment evaluation
- •- Patients with a history of other malignancies, except if there is a disease-free interval of at least 5 years or patients with a prior history of adequately treated basal cell carcinoma of the skin or carcinoma in-situ of the cervix
- •- Clinical significant infection
- •- Symptomatic cardiac disease
- •- Brain metastases
- •- Any medical condition that might be aggravated by treatment or which could not be controlled: i.e. active infection
- •- Organ transplantation or autoimmune disease
- •- Systematic treatment with adrenocortical hormone
- •- Epilepsy, other central nervous disease or significant psycological conditions which do not permit medical follow-up and compliance with the study
研究者
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