Sirolimus (Rapamune®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes - Sirolimus for Hu-PNS

Erasmus MC0 个研究点开始时间: 2008年3月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•i)PEM/PSN associated with high (>=1:400 by IIF) titer anti-Hu antibodies.
•ii)IIF (indirect immunofluorescence) has been confirmed by Western blotting using purified HuD fusion protein as substrate.
•iii)The neurological symptoms must still be progressing defined as neurological deterioration over the last 4 weeks.
•iv)Patients aged >=18 years.
•v)Patients who receive or will receive concomitant anti-tumor therapy are allowed to participate.
•vi)Patients who have given written 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

•i)Patients who have reached a neurological plateau phase more than 4 weeks before inclusion date (‘damage is done’).
•ii)Patients who are unwilling to undergo lumbar puncture.
•iii)Liver enzyme elevations of more than 5-fold normal values
•iv)Renal failure (GFR < 30 ml/min)
•v)Extreme hypertriglyceridemia (> 10 mmol/L) and extreme hypercholesterolemia (> 10 mmol/L)
•vi)Active infection
•vii)Women of childbearing potential who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions.

发起方