Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma
This trial is active, not recruiting.
|Treatments||filgrastim, doxorubicin hydrochloride, topotecan hydrochloride, vincristine sulfate|
|Sponsor||Children's Cancer and Leukaemia Group|
|Start date||March 2008|
|End date||January 2010|
|Trial size||63 participants|
|Trial identifier||NCT00392340, CCLG-NB-2006-05, CDR0000508641, EU-20641, EUDRACT-2005-000915-80|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Bristol, United Kingdom||Institute of Child Health at University of Bristol||no longer recruiting|
|Cambridge, United Kingdom||Addenbrooke's Hospital||no longer recruiting|
|Leeds, United Kingdom||Leeds Cancer Centre at St. James's University Hospital||no longer recruiting|
|Liverpool, United Kingdom||Royal Liverpool Children's Hospital, Alder Hey||no longer recruiting|
|London, United Kingdom||Great Ormond Street Hospital for Children||no longer recruiting|
|Manchester, United Kingdom||Royal Manchester Children's Hospital||no longer recruiting|
|Newcastle-Upon-Tyne, United Kingdom||Sir James Spence Institute of Child Health at Royal Victoria Infirmary||no longer recruiting|
|Nottingham, United Kingdom||Queen's Medical Centre||no longer recruiting|
|Sheffield, United Kingdom||Children's Hospital - Sheffield||no longer recruiting|
|Edinburgh, United Kingdom||Royal Hospital for Sick Children||no longer recruiting|
|Glasgow, United Kingdom||Royal Hospital for Sick Children||no longer recruiting|
Objective response rate (complete or partial) > 50% after 2 courses of topotecan hydrochloride, vincristine, and doxorubicin hydrochloride
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
Toxicity and incidence of adverse events
Male or female participants from 1 year up to 20 years old.
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
|Official title||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)]|
|Description||OBJECTIVES: Primary - Assess whether treatment with topotecan hydrochloride, vincristine, and doxorubicin hydrochloride can achieve a satisfactory response rate in pediatric patients with stage 4 neuroblastoma that failed to respond to rapid first-line treatment. Secondary - Determine time to progression in these patients. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter, open-label study. Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and vincristine IV continuously and doxorubicin hydrochloride IV continuously over 48 hours on days 5 and 6. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 9 and continuing until blood counts recover. Treatment repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve partial response (PR) after two courses of treatment receive an additional two courses. Patients who achieve complete response or very good PR are treated according to the standard therapy in protocol SIOP-EUROPE- HR-NBL-1. Patients who fail to achieve PR after 2 courses receive further treatment at the physician's discretion. Patients are followed periodically for at least 3 years. PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study.|
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