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Status:

UNKNOWN

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

Lead Sponsor:

Children's Cancer and Leukaemia Group

Conditions:

Neuroblastoma

Eligibility:

All Genders

1-20 years

Phase:

PHASE2

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 d...

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 ne...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    63 Patients enrolled

    Trial Details

    Trial ID

    NCT00392340

    Start Date

    March 1 2008

    Last Update

    September 17 2013

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    Institute of Child Health at University of Bristol

    Bristol, England, United Kingdom, BS2 8AE

    2

    Addenbrooke's Hospital

    Cambridge, England, United Kingdom, CB2 2QQ

    3

    Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, United Kingdom, LS9 7TF

    4

    Royal Liverpool Children's Hospital, Alder Hey

    Liverpool, England, United Kingdom, L12 2AP