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NCT01857934 · ClinicalTrials.gov registry record · Phase 2
Therapy for Children With Advanced Stage Neuroblastoma
A Phase 2 study of Neuroblastoma, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
- 1
- Study location
NCT01857934 is a Phase 2 study of Neuroblastoma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 153 participants, below the 237-participant average among 94 other Neuroblastoma trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01857934, a Phase 2 study of Neuroblastoma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
- 1
- Study location
Study 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 (ch14.18) 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 hu14.18K322A, given with induction chemotherapy. PRIMARY OBJECTIVE: * To study the efficacy \[response: complete remission + partial remission (CR+PR)\] to two initial courses of cyclophosphamide and topotecan combined with hu14.18K322A (4 doses/course 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 hu14.18K322A to treatment. SECONDARY OBJECTIVES: * To study the feasibility of delivering hu14.18K322A to 6 cycles induction chemotherapy and describe the antitumor activity (CR+PR) 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 hu14.18K322A with allogeneic natural killer (NK) cell
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG topotecan
- BIOLOGICAL hu14.18K322A
- PROCEDURE peripheral blood stem cell harvest
- PROCEDURE surgical resection
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2013-07-05 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01857934
The ClinicalTrials.gov registry entry for NCT01857934 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 237-participant average among 94 other Neuroblastoma trials with a reported enrollment target (35% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT01857934 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT01857934 about?
NCT01857934 is a clinical study titled "Therapy for Children With Advanced Stage Neuroblastoma". 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...
What is the current status of trial NCT01857934?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2013-07-05. Estimated completion is 2025-12.
What conditions does trial NCT01857934 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT01857934?
The interventions under investigation include: cyclophosphamide (DRUG), topotecan (DRUG), hu14.18K322A (BIOLOGICAL), peripheral blood stem cell harvest (PROCEDURE), surgical resection (PROCEDURE).
Who is sponsoring clinical trial NCT01857934?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01857934 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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