drugset / Trial / NCT01701479
Long Term Continuous Infusion ch14.18/CHO Plus s.c. Aldesleukin (IL-2)
Phase 1/2
Unknown
288 enrolled
St. Anna Children's Cancer Research
Alder Hey Children's NHS Foundation Trust · collabCentre Leon Berard · collabChildren's University Hospital, Ireland · collabFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · collabFondazione IRCCS Istituto Nazionale dei Tumori, Milano · collabGreat Ormond Street Hospital for Children NHS Foundation Trust · collabGustave Roussy, Cancer Campus, Grand Paris · collabHospital Infantil Universitario Niño Jesús, Madrid, Spain · collabHospital Universitario La Fe · collabInstitut Curie · collabIstituto Giannina Gaslini · collabJena University Hospital · collabJohann Wolfgang Goethe University Hospital · collabMedical University Innsbruck · collabMedical University of Graz · collabNHS Greater Glasgow and Clyde · collabNewcastle-upon-Tyne Hospitals NHS Trust · collabSchneider Children's Medical Center, Israel · collabSt. Anna Children's Hospital, Vienna · collabThe Leeds Teaching Hospitals NHS Trust · collabUniversity Hospital Southampton NHS Foundation Trust · collabUniversity Hospital Tuebingen · collabUniversity Hospital, Toulouse · collabUniversity Hospitals Bristol and Weston NHS Foundation Trust · collabUniversity Medicine Greifswald · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The main aim of this clinical trial is to find a way of giving ch14.18/CHO, in combination with subcutaneous aldesleukin (IL-2) and oral isotretinoin (13-cis-RA), to children and young people with primary refractory or relapsed neuroblastoma without intravenous morphine.
Timeline
- Start
- 2012-01
- Primary completion
- 2020-12
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 7 mg/m2 | — |
| Subject | Dinutuximab | Monoclonal antibody | 10 mg/m2 | — |
| Subject | Dinutuximab | Monoclonal antibody | 15 mg/m2 | — |
| Subject | aldesleukin | Protein / enzyme biologic | 6e+06 unknown | Subcutaneous |
| Background | Isotretinoin | Other / unclassified | 160 mg/m2 | Oral |