CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m²) for five
consecutive days will be administered every 4 weeks, starting 60-180 days after previous
haploidentical stem cell transplantation.
Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants
will be premedicated with an intravenous antihistamine and ranitidine within approximately 30
minutes prior and during the infusion of the study agent Pain as an anticipated side effect
is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be
evaluated after 3 and 6 courses and after 1 year
Phase:
Phase 2
Details
Lead Sponsor:
University Children's Hospital Tuebingen University Children’s Hospital Tuebingen