neuroblastoma neuroblastoma
Conditions
Interventions
SPJ-101-CA (isotretinoin) PO administration.
128 mg/m^2/day 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
isotoretinoin
Sponsors
Makimoto Atsushi
Yuza Yuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged between 1 and 18 years at the time of informed consent (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 transplant and radiotherapy (5) Within 100 days after the most recent anticancer 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) Continuing active anticancer treatments (2) Concomitant malignancy (3) Allergy to gelatin (4) A 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 (7) Inappropriate to be enrolled by investigators' judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of serious adverse events related to SPJ-101-CA (isotretinoin) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Event-free survival (1 year) (2) Overall survival (1 year) (3) Rate of serious adverse events (4) Pharmacokinetics | — |
Contacts
Public ContactAsuka Yamaguchi
Tokyo Metropolitan Children's Medical Center
Outcome results
None listed