Isotretinoin maintenance for high risk neuroblastoma

Phase 2

Recruiting

• Conditions: neuroblastoma; C04.557.465.625.600.590.650.550

• Registration Number: JPRN-jRCTs031200107
• Lead Sponsor: Makimoto Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients without any events for 1 year after starting isotretinoin

Secondary Outcome Measures

Name	Time	Method
Event-free survival, Overall survival rate (1 year), rate of adverse events and those with causality, pharmacokinetic analyses