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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 17 人开始时间: 待定最近更新: 2024年5月13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.

•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.

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