EUCTR2012-000351-14-GB进行中（未招募）1 期
A PHASE II STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT) OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER - MELCAP
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 29
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
- •1.Men aged =18 years
- •2.Histological diagnosis of prostate cancer
- •3.Progressive Castration-resistant Prostate Cancer defined as:
- •a rising PSA; or
- •development of new sites of disease in the presence of a suppressed testosterone (<1.5 nmol/l); or
- •if 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)
- •4.ECOG performance status 0-2
- •5.Adequate haematological reserve
- •Unsupported Hb >10.0 g/l
- •Platelets >100x109/l
- •WBC >3x109/l
- •Neutrophils >1.5x109/l
- •6.Renal sufficiency:
- •Creatinine <200 µmol/l
- •7.Hepatic sufficiency:
- •Bilirubin <30 µmol/l
- •ALT <3xULN unless due to liver metastasis
- •8.Able to give written informed consent and comply with the protocol study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients who have suffered a previous hypersensitivity reaction to melphalan
- •2.Patients with known hypersensitivity to lenograstim or to any of the excipients
- •3.History of myeloid malignancy
- •4.Lenograstim should not be administered concurrently with cytotoxic chemotherapy (i.e. on the same day)
- •5.Previous invasive carcinoma <3 years prior to study entry
- •6.Cardiac condition contra-indicating large volume venesection (i.e., active angina or cardiac failure)
- •7.Current treatment with another investigational medicinal product or participation in another investigational therapeutic study, at any time during the treatment period and 30 days preceding study entry
- •8.Life expectancy <12 weeks
- •9.Unwilling or unable to provide written informed consent
研究者
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