A safety, efficacy and pharmacokinetic study of SPJ-101CA as a maintenance therapy for newly diagnosed high risk neuroblastoma

Phase 2

Recruiting

• Conditions: neuroblastoma; C04.557.465.625.600.590.650.550

• Registration Number: JPRN-jRCT2031220687
• Lead Sponsor: Makimoto Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of serious adverse events related to SPJ-101-CA (isotretinoin)

Secondary Outcome Measures

Name	Time	Method
(1) Event-free survival (1 year)<br>(2) Overall survival (1 year)<br>(3) Rate of serious adverse events<br>(4) Pharmacokinetics