Clinical trial · Interventional
Response-based Treatment of High-risk Neuroblastoma
NCT02771743CI-TRIAL-00022363unknownPhase 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 improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.
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 |
|---|---|---|---|
| Newly Diagnosed High Risk Neuroblastoma | High Risk Neuroblastoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
| Isotretinoin | Drug | — | UNRESOLVED |
| MIBG |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High risk neuroblastoma
- description
- 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT) * Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT * Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
- interventionNames
- Drug: Cisplatin
- Drug: Doxorubicin
- Drug: Etoposide
- Drug: Cyclophosphamide
- Drug: Ifosfamide
- Drug: Carboplatin
- Procedure: Tandem HDCT/auto-SCT
- Radiation: Radiotherapy
- Drug: Interleukin-2
- Drug: Isotretinoin
- Radiation: MIBG
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed high risk neuroblastoma * Patients with informed consent Exclusion Criteria: * Patients with progressive disease or relapse * Patients who underwent high dose chemotherapy before * Patients with organ dysfunction as follows (creatinine elevation \> 3 x upper limit of normal, Total bilirubin \> 3 x upper limit of normal, aspartate transaminase/alanine transaminase \> 5 x upper limit of normal), ejection fraction \<40% * Pregnant or nursing women
References
Publications (0)
Data not yet available
No reference posted for this study.