Clinical trial · Interventional
Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR)
- 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)
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma. PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.
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 (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event-free survival (EFS)
Secondary outcomes (9)
- measure
- Overall survival (OS)
- measure
- Impact of well established clinical and molecular risk factors on EFS and OS
- measure
- Early response, measured after 2 courses of induction chemotherapy
- measure
- Response to induction therapy, measured before autologous stem cell transplantation
- measure
- Toxicity during the first 2 courses and the last 6 courses of induction chemotherapy
- measure
- Impact of the extent of initial and best surgery on outcome and frequency of complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma according to any of the following criteria: * Histological diagnosis from tumor tissue * Presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine * High-risk disease, meeting 1 of the following criteria: * Stage 4 disease, regardless of the MYCN status (1-21 years of age) * Stage 1-3 or 4S disease with MYCN amplification (6 months -21 years of age) PATIENT CHARACTERISTICS: * Not pregnant or nursing * Fertile patients must use effective contraception (hormonal contraception or intra-uterine device \[IUD\]) PRIOR CONCURRENT THERAPY: * No concurrent participation in another clinical trial that would preclude the interventions or outcome assessment of this clinical trial * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available