Ignite Creation Date:
2024-05-06 @ 1:36 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01857934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2013-05-16
Brief Title:
Therapy for Children With Advanced Stage Neuroblastoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Neuroblastoma Protocol 2012 Therapy for Children With Advanced Stage High-Risk Neuroblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
Neuroblastoma is the most common extracranial solid tumor in childhood with nearly 50 of patients presenting with widespread metastatic disease The current treatment for this group of high-risk patients includes intensive multi-agent chemotherapy induction followed by myeloablative therapy with stem-cell rescue consolidation and then treatment of minimal residual disease MRD with isotretinoin Recently a new standard of care was established by enhancing the treatment of MRD with the addition of a monoclonal antibody ch1418 which targets a tumor-associated antigen the disialoganglioside GD2 which is uniformly expressed by neuroblasts Despite improvement in 2-year event-free survival EFS of 20 more than one-third of children with high-risk neuroblastoma HR defined in still cannot be cured by this approach Therefore novel therapeutic approaches are needed for this subset of patients This study will be a pilot Phase II study of a unique anti-disialoganglioside anti-GD2 monoclonal antibody mAb called hu1418K322A given with induction chemotherapy
PRIMARY OBJECTIVE
To study the efficacy response complete remission partial remission CRPR to two initial courses of cyclophosphamide and topotecan combined with hu1418K322A 4 dosescourse followed by GM-CSF in previously untreated children with high-risk neuroblastoma
To estimate the event-free survival of patients with newly diagnosed high-risk neuroblastoma treated with the addition of hu1418K322A to treatment
SECONDARY OBJECTIVES
To study the feasibility of delivering hu1418K322A to 6 cycles induction chemotherapy and describe the antitumor activity CRPR of this 6 course induction therapy
To estimate local control and pattern of failure associated with focal intensity modulated or proton beam radiation therapy dose delivery in high-risk abdominal neuroblastoma
To describe the tolerability of four doses of hu1418K322A with allogeneic natural killer NK cells from an acceptable parent in the immediate post-transplant period day 2 - 5 after peripheral blood stem cell PBSC infusion in consenting participants
To describe the tolerability of hu1418K322A with interleukin-2 and GM-CSF as treatment for minimal residual disease MRD
PRIMARY OBJECTIVE
To study the efficacy response complete remission partial remission CRPR to two initial courses of cyclophosphamide and topotecan combined with hu1418K322A 4 dosescourse followed by GM-CSF in previously untreated children with high-risk neuroblastoma
To estimate the event-free survival of patients with newly diagnosed high-risk neuroblastoma treated with the addition of hu1418K322A to treatment
SECONDARY OBJECTIVES
To study the feasibility of delivering hu1418K322A to 6 cycles induction chemotherapy and describe the antitumor activity CRPR of this 6 course induction therapy
To estimate local control and pattern of failure associated with focal intensity modulated or proton beam radiation therapy dose delivery in high-risk abdominal neuroblastoma
To describe the tolerability of four doses of hu1418K322A with allogeneic natural killer NK cells from an acceptable parent in the immediate post-transplant period day 2 - 5 after peripheral blood stem cell PBSC infusion in consenting participants
To describe the tolerability of hu1418K322A with interleukin-2 and GM-CSF as treatment for minimal residual disease MRD
Detailed Description:
The phases of the study are
1 Screening phase Tests and evaluations will be done before treatment starts
2 Induction phase Includes chemotherapy plus hu1418K322A mAb Participants will also have surgery during this part of the study to remove as much tumor as possible
3 ConsolidationIntensification phase Includes high doses of chemotherapy and blood stem cell transplantation with additional experimental minimal residual disease MRD treatment Participants will also get radiation treatment to all sites of the tumors after recovery from the stem cell transplant
4 MaintenanceMRD treatment phase With immune therapy in addition to the standard treatment with the drug isotretinoin
1 Screening phase Tests and evaluations will be done before treatment starts
2 Induction phase Includes chemotherapy plus hu1418K322A mAb Participants will also have surgery during this part of the study to remove as much tumor as possible
3 ConsolidationIntensification phase Includes high doses of chemotherapy and blood stem cell transplantation with additional experimental minimal residual disease MRD treatment Participants will also get radiation treatment to all sites of the tumors after recovery from the stem cell transplant
4 MaintenanceMRD treatment phase With immune therapy in addition to the standard treatment with the drug isotretinoin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2013-00034 | REGISTRY | NCI Clinical Trial Registration Program | None |