NCT00392340

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

September 17, 2013

Status Verified

June 1, 2009

Enrollment Period

1.8 years

First QC Date

October 25, 2006

Last Update Submit

September 16, 2013

Conditions

Neuroblastoma

Keywords

recurrent neuroblastomadisseminated neuroblastoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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

Interventions

filgrastimBIOLOGICAL
doxorubicin hydrochlorideDRUG
topotecan hydrochlorideDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

FilgrastimDoxorubicinTopotecanVincristine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCamptothecinAlkaloidsHeterocyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Guy Makin, MD, PhD

    Royal Manchester Children's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 26, 2006

Study Start

March 1, 2008

Primary Completion

January 1, 2010

Last Updated

September 17, 2013

Record last verified: 2009-06

Locations

GB(11)