Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma

Phase 2

• Conditions: Neuroblastoma

• Registration Number: NCT00392340
• Lead Sponsor: Children's Cancer and Leukaemia Group

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Study Start: 2008-03
• Status Verified: 2009-06
• Primary Completion: 2010-01
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate (complete or partial) > 50% after 2 courses of topotecan hydrochloride, vincristine, and doxorubicin hydrochloride

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Institute of Child Health at University of Bristol; 🇬🇧 Bristol, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Queen's Medical Centre; 🇬🇧 Nottingham, England, United Kingdom

Great Ormond Street Hospital for Children; 🇬🇧 London, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey; 🇬🇧 Liverpool, England, United Kingdom

Children's Hospital - Sheffield; 🇬🇧 Sheffield, England, United Kingdom

Royal Hospital for Sick Children; 🇬🇧 Glasgow, Scotland, United Kingdom

Sir James Spence Institute of Child Health at Royal Victoria Infirmary; 🇬🇧 Newcastle-Upon-Tyne, England, United Kingdom

Royal Manchester Children's Hospital; 🇬🇧 Manchester, England, United Kingdom