Ignite Creation Date:
2024-05-06 @ 2:57 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02169609
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2014-06-12
Brief Title:
Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
Phase II Single Arm Study to Assess Dinutuximab Ch 1418 Combined With the Cytokines Granulocyte-macrophage Colony Stimulating Factor GM-CSF and IL-2 in Patients With High-risk Neuroblastoma Not Eligible to Other Immunotherapy Trials
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate safety of the triple COG schema with the monoclonal antibody Dinutuximab cytokines GM-CSF and IL2 and isotretinoin 13-cis-retinoic acid or RA in patients with high-risk neuroblastoma
Detailed Description:
Assess toxicity and safety of subcutaneous GM-CSF and iv IL-2 in enhancing Dinutuximab-mediated ablation of Bone Marrow BM disease in patients with high-risk neuroblastoma who have achieved a Complete Response or Very Good Partial Response of the macroscopic disease in the investigators institution
Assess response of minimal residual disease MRD of the anti-GD2 monoclonal antibody Dinutuximab combined with granulocyte-macrophage colony stimulating factor GM-CSF and IL-2 in patients with high-risk neuroblastoma NB More precisely to apply real-time quantitative RT-PCR to test the hypothesis that minimal residual disease content of BM after the first treatments with dinutuximabGM-CSF has significant prognostic impact on relapse-free survival
Assess response of minimal residual disease MRD of the anti-GD2 monoclonal antibody Dinutuximab combined with granulocyte-macrophage colony stimulating factor GM-CSF and IL-2 in patients with high-risk neuroblastoma NB More precisely to apply real-time quantitative RT-PCR to test the hypothesis that minimal residual disease content of BM after the first treatments with dinutuximabGM-CSF has significant prognostic impact on relapse-free survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None