A Phase I study of 131-I mIBG followed by Nivolumab and Dinutuximab beta Antibodies in children with relapsed/refractory Neuroblastoma.

niversity Hospital Southampton NHS Foundation Trust (UK)0 个研究点目标入组 36 人开始时间: 2023年2月1日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1 Relapsed or refractory high risk neuroblastoma (as defined by INRG criteria)
•2 MIBG avid disease on imaging within 4 weeks prior to study registration .
•3 Performance status = 60%, estimated life expectancy = 12 weeks
•4 Adequate renal, cardiac and hepatic function.
•5 Patients with CNS metastasis may be included provided that CNS disease has been previously treated and has been stable for 4 weeks prior to study entry
•6 At least 1 x 106 /Kg CD34 autologous stem cells stored and available if needed
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3
•F.1.2 Adults (18-64 years) no
•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

•1. Patients who have previously received ch14.18 (CHO or SP2/0) and have had severe or life threatening toxicity necessitating withdrawal of treatment previously
•2. Co-existent autoimmune disease
•3. Patients receiving corticosteroids (other than physiological replacement) or other chronic immunosuppressive agents.

发起方

niversity Hospital Southampton NHS Foundation Trust (UK)