EUCTR2006-002210-36-GB进行中（未招募）1 期
A Phase II study evaluating intravenous Melphalan with autologous whole blood stem cell transplantation (PBSCT) in patients with Androgen –Independent Prostate Cancer (AIPC) - Melphalan in AIPC / Mel-CaP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Histological diagnosis of prostate cancer
- •Progressive androgen independent prostate cancer defined as:
- •o a rising PSA; or
- •odevelopment of new sites of disease in the presence of a suppressed testosterone (<1.5 nmol/l); or
- •oif testosterone > 1.5nmol/l, maximum androgen blockade failure (MAB)
- •(MAB = GnRH analogue and peripheral anti-androgen – flutamide 250mg 3x/day or bicalutamide 50mg/ day or cyproterone 100mg 3x/day)
- •ECOG performance status 0-2
- •Adequate haematological reserve
- •oUnsupported Hb > 11.0g/l
- •oPlatelets > 100x109/l
- •oWBC > 3x109/l
- •oNeutrophils > 1.5x109/l
- •Renal sufficiency
- •oCreatinine <200 µmol/l
- •oBilirubin < 30µmol/l
- •oALT < 3xULN
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous invasive carcinoma < 3 years prior to study entry
- •Cardiac condition contra-indicating large volume venesection (i.e., active angina or cardiac failure)
- •Current participation in any other investigational drug study
- •Life expectancy < 12 weeks
- •Unwilling or unable to provide written informed consent
研究者
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