EUCTR2004-003699-13-ES进行中（未招募）不适用
Phase II/III, Multicenter, Open-label, Randomized Study Comparing Autologous Intravesical Macrophage Cell Therapy (Bexidem”) to Intravesical BCG-Therapy in Patients With Superficial Papillary Bladder Cancer Who Have Undergone Complete Transurethral Resection
INMUNO DESIGNED MOLECULES (IDM)0 个研究点目标入组 650 人开始时间: 2005年5月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 650
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
- •·Male and female patients
- •Over 18 years of age
- •Fully resected papillary transitional cell carcinoma
- •Stage TaGI, TaGII, TaGIII, T1GI or T1GII (N0, M0)
- •Either of the following:
- •Plurifocal tumors or,
- •Unifocal tumor with = 2 tumor occurences within the last 24 months
- •WHO performance state 0-2
- •Normal upper urinary tract as documented by either IV urography or CT-scan
- •Blood creatinine < 200 µmol/L, ALT and AST < 2,5 x ULN, Leukocytes = 3,500/mm3
- •Able to understand and follow treatment scheme
- •Signed and dated Informed Consent
- •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
- •·= T1 GIII bladder cancer
- •Carcinoma in situ (CIS)
- •Active tuberculosis/Other active infection (including urinary tract infection) and/or infections that may compromise the immune system such as HIV, HTLV, Hepatitis B or Hepatitis C infection/History of other active malignancy within five years, except adequately treated basal cell and squamous cell carcinoma of the skin /Other serious illness or medical conditions (e.g. history of significant cardiac or respiratory dysfunction)
- •Patients with a contra-indication preventing apheresis / History of autoimmune-related disorder / Known hypersensitivity to any of the components of the study drugs (e.g. DMSO)
- •Immunosuppression or congenital or acquired immune deficiencies, whether due to concurrent disease (e.g. AIDS, leukaemia, lymphoma), cancer therapy (cytotoxic drugs, radiotherapy) or immunosuppressive therapy (e.g. corticosteroids, cyclosporinFamily history of Creutzfeldt-Jacob disease and/or Risk of Creutzfeldt-Jacob disease defined as patient having received extracted growth hormone or neurosurgery before 1996
- •Prior systemic reaction to BCG therapy
- •Pregnant or nursing women
研究者
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