Clinical trial · Interventional
Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma
An Open-Label, Multicentre, Phase II Study of TVD as Treatment for Children With Stage 4 Neuroblastoma Failing to Respond to First-Line Treatment According to HR-NBL-01/ E-SIOP [Topotecan-Vincristine-Doxorubicin in Children With Stage 4 Neuroblastoma Failing to Respond to COJEC (TVD)]
- 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: Drugs used in chemotherapy, such as topotecan, vincristine, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving topotecan together with vincristine and doxorubicin works in treating young patients with refractory stage 4 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate (complete or partial) > 50% after 2 courses of topotecan hydrochloride, vincristine, and doxorubicin hydrochloride
Secondary outcomes (2)
- measure
- Progression-free survival at the time of local progression or relapse, progression of pre-existing metastases, metastatic relapse, second primary malignancy, or death from any cause
- measure
- Toxicity and incidence of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage 4 neuroblastoma * Failed to achieve adequate metastatic partial response after first-line therapy while enrolled on protocol SIOP-EUROPE-HR-NBL-1 PATIENT CHARACTERISTICS: * Neutrophil count \> 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.36 mg/dL * Bilirubin ≤ 2.92 mg/dL * AST and ALT \< 2.5 times upper limit of normal * Glomerular filtration rate ≥ 60 mL/min * Normal cardiac function on echocardiography * No severe organ dysfunction * No active hepatitis C or hepatitis B virus positivity * No HIV infection PRIOR CONCURRENT THERAPY: * No anti-tumor chemotherapy within the past 10 days * No radiotherapy within the past 30 days * No other investigational drugs within the past 30 days * No prior doxorubicin hydrochloride
References
Publications (0)
Data not yet available