Clinical trial · Interventional
High Dose Chemotherapy and Autologous Transplant for Neuroblastoma
High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Rescue for Neuroblastoma: Standard of Care Considerations
NCT01526603CI-TRIAL-00074377completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a standard of care document, outlining the therapy for children with high risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous stem cell infusion | Biological | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Granulocyte colony stimulating factor | Biological | — | UNRESOLVED |
| Isotretinoin (13-cis-retinoic acid) | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients Treated for Neuroblastoma
- description
- According to patient weight and renal function, consolidation chemotherapy using various doses of Melphalan, Etoposide, and Carboplatin followed by autologous stem cell infusion and serial post-transplant Granulocyte Colony Stimulating Factor, radiation therapy and Isotretinoin maintenance therapy.
- interventionNames
- Drug: Carboplatin
- Biological: Autologous stem cell infusion
- Biological: Granulocyte colony stimulating factor
- Radiation: Radiation therapy
- Drug: Isotretinoin (13-cis-retinoic acid)
- Drug: Melphalan
- Drug: Etoposide
Primary outcomes (1)
- measure
- Number of Patients with Successful Engraftment
- timeFrame
- Day 42
- description
- The time to neutrophil engraftment will be assessed by standard statistical approaches.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Less than 30 years of age at diagnosis of neuroblastoma * No evidence of disease progression: defined as increase in tumor size of \>25% or new lesions * Recovery from last induction course of chemotherapy (absolute neutrophil count \> 500 and platelet \> 20,000) * No uncontrolled infection * Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10\^6 CD34 cells/kg for transplant are mandatory and 2 x 10\^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged) * Adequate organ function defined as: * Hepatic: aspartate aminotransferase (AST) \< 3 x upper limit of institutional normal 8 Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 50%, no clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular filtration rate (GFR) \> 60 mL/min/1.73m\^2 If a creatinine clearance is performed at end induction and the result is \< 100 ml/min/1.73m\^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of \< 100 ml/min/1.73m\^2 Exclusion Criteria * Patients with progressive disease should consider participating in phase I studies since consolidation therapy using the regimen outlined in this document have not been determined to be useful. * Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet organ function criteria.
References
Publications (0)
Data not yet available
No reference posted for this study.