JPRN-jRCT2031220687
Recruiting
Phase 2
A safety, efficacy and pharmacokinetic study of SPJ-101CA as a maintenance therapy for newly diagnosed high risk neuroblastoma - SPJ-101CA for neuroblastoma
Makimoto Atsushi0 sites16 target enrollmentMarch 7, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- neuroblastoma
- Sponsor
- Makimoto Atsushi
- Enrollment
- 16
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •(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
Outcomes
Primary Outcomes
Not specified
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