neuroblastoma neuroblastoma
Conditions
Interventions
Isotretinoin, PO. For 14 days followed by 14-day break,
repeating 6 courses in a 28-day cycle.
D02.455.326.271.665.202.495.325, D02.455.426.392.368.367.379.249.700.325, D02.455.849.131.495.325, D23.767.261.700.325
isotretinoin
Sponsors
Makimoto Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 1 and 18 2. Histopathological diagnosis with neuroblastoma or ganglioneuroblastoma 3. Stratified to high risk group according to International Neuroblastoma Risk Grouping System 4. No progression after primary treatment including chemotherapy, high-dose chemotherapy with hematopoietic stem cell transplantation and radiotherapy 5. Within 84 days after the most recent hematopoietic stem cell transplantation or the last day of post-transplantation therapy 6. No severe organ damage to disturb protocol treatment 7. No active infectious disease 8. Written informed consent from the patient and/or the guardian
Exclusion criteria
Exclusion criteria: 1. During an active anticancer treatment or planning anticancer treatment except for immunotherapy including dinutuximab 2. Concomitant malignancy 3. Allergy to gelatin 4. Female patient in pregnancy or possible pregnancy, or during breast feeding 5. Concomitant psychiatric disorders 6. Complications which would be an obstacle to observe the treatment protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients without any events for 1 year after starting isotretinoin | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival, Overall survival rate (1 year), rate of adverse events and those with causality, pharmacokinetic analyses | — |
Contacts
Public ContactAtsushi Makimoto
Tokyo Metropolitan Children's Medical Center
Outcome results
None listed