Clinical trial · Interventional
Tandem High-dose Chemotherapy and Autologous Stem Cell Rescue in Patients With High-risk Neuroblastoma
NCT00793845CI-TRIAL-00034943completedPhase 2ClinicalTrials.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)
The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCR in children with high-risk neuroblastoma. In the present study, a single arm trial of tandem HDCT/ASCR will be carried out. In the present study, the investigators will investigate whether tandem HDCT/ASCR might improve the survival of patients with high-risk neuroblastoma with acceptable toxicity.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Thiotepa | Drug | Thiotepa | ALIAS |
| Total body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High risk neuroblastoma
- description
- 1. Conventional chemotherapy (9 cycles) 2. Surgery conventional chemotherapy (after 6 cycles of chemotherapy) 3. Tandem HDCT/autoSCT * First HDCT (cyclophosphamide, etoposide, carboplatin) * Second HDCT (total body irradiation, thiotepa, melphalan) 4. Local radiotherapy 5. Retinoic acid, interleukin-2
- interventionNames
- Drug: Cyclophosphamide
- Drug: Etoposide
- Drug: Carboplatin
- Drug: Thiotepa
- Drug: Melphalan
- Radiation: Total body irradiation
Primary outcomes (1)
- measure
- Overall survival and event-free survival, short-term and long-term toxicity of tandem high-dose chemotherapy and autologous stem cell transplantation
- timeFrame
- from 1 year after second high-dose chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with high-risk neuroblastoma * Patients with intermediate-risk neuroblastoma if gross tumor remained after surgery Exclusion Criteria: * Patients with progressive disease before high-dose chemotherapy * Patients whose parents want to stop or change the planned treatment * Patients with organ toxicities of NCI grade \>2 before high-dose chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.