Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma
NCT ID: NCT00392340
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
63 participants
INTERVENTIONAL
2008-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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filgrastim
doxorubicin hydrochloride
topotecan hydrochloride
vincristine sulfate
Eligibility Criteria
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Inclusion Criteria
* 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
1 Year
20 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Guy Makin, MD, PhD
Role: STUDY_CHAIR
Royal Manchester Children's Hospital
Locations
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Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CCLG-NB-2006-05
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-000915-80
Identifier Type: -
Identifier Source: secondary_id
EU-20641
Identifier Type: -
Identifier Source: secondary_id
CDR0000508641
Identifier Type: -
Identifier Source: org_study_id