Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030719
Recruitment Status : Unknown
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : June 24, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet known which treatment regimen is more effective in treating neuroblastoma.

PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma.

Condition or disease Intervention/treatment Phase
Neuroblastoma Biological: filgrastim Biological: monoclonal antibody Ch14.18 Drug: busulfan Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: isotretinoin Drug: melphalan Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: High Risk Neuroblastoma Study 1 Of Siop-Europe
Study Start Date : December 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Event-free survival at 3 years
  2. Mean number of febrile events during induction

Secondary Outcome Measures :
  1. Response rate assessed by the International Neuroblastoma Response Criteria after 4 and 8 induction chemotherapy courses
  2. Event-free survival at 5 years
  3. Overall survival
  4. Toxicity
  5. Biological factors (i.e., MycNM amplification, 1p deletion, ploidy, 17 q+, CD44, and Trk-A)
  6. Serum concentrations of lactic dehydrogenase, ferritin, neurone specific enolase
  7. Urinary catecholamines at diagnosis

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of neuroblastoma according to International Neuroblastoma Staging System

    • Stage 2 or 3 with MycN amplification
    • Stage 4
  • Tumor material available for determination of biological prognostic factors



  • 1 to 20 at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin less than 3 times normal
  • ALT less than 3 times normal


  • Creatinine less than 1.5 mg/mL
  • Creatinine clearance and/or glomerular filtration rate at least 60 mL/min


  • Shortening fraction at least 28% OR
  • Ejection fraction at least 55%
  • No clinical congestive heart failure


  • Chest x-ray normal
  • Oxygen saturation normal


  • HIV negative
  • No Brock grade 2 or greater
  • No uncontrolled infections requiring IV antivirals, antibiotics, or antifungals
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No more than 1 prior chemotherapy regimen for localized unresectable disease
  • No concurrent anthracyclines
  • No other concurrent chemotherapy


  • Not specified


  • Not specified


  • Not specified


  • No other concurrent investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030719

  Hide Study Locations
St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Ruth Ladenstein, MD    43-1-404-700      
Universitair Ziekenhuis Gent Recruiting
Ghent, Belgium, B-9000
Contact: Genevieve Laureys, MD, PhD    32-9-240-21-11   
Aarhus Universitetshospital - Aarhus Sygehus Recruiting
Aarhus, Denmark, DK-8000
Contact: Henrik Schroder, MD    45-89-49-44-44      
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: D. Valteau-Couanet    33-1-4211-4339      
Our Lady's Hospital for Sick Children Crumlin Recruiting
Dublin, Ireland, 12
Contact: Fin Breatnach, MD, FRCPE    353-1-409-6659   
Schneider Children's Medical Center of Israel Recruiting
Petah-Tikva, Israel, 49202
Contact: Isaac Yaniv, MD    972-3-925-3669   
Fondazione Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Roberto Luksch, MD    39-02-2390-2592   
Rikshospitalet University Hospital Recruiting
Oslo, Norway, 0027
Contact: Ingebjorg Storm-Mathisen, MD    47-23-07-45-60      
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA Recruiting
Lisbon, Portugal, 1099-023 Codex
Contact: Ana Forjaz De Lacerda, MD, FAAP    351-21-726-0429   
Hospital Universitario La Fe Recruiting
Valencia, Spain, 46009
Contact: Victoria Castel    34-96-386-2700      
Karolinska University Hospital - Solna Recruiting
Stockholm, Sweden, S-171 76
Contact: Per Kogner, MD, PhD    46-85-177-3534   
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Maja B. Popovic, MD    41-21-314-3567   
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, England, United Kingdom, B4 6NH
Contact: Martin W. English, MD    44-121-333-8412   
Institute of Child Health at University of Bristol Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: Pamela Kearns, MD    44-117-342-8260      
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Amos Burke, MD    44-1223-348-151      
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Adam Glaser, MD    44-113-206-4984   
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: Johann Visser, MD    44-116-258-5309   
Royal Liverpool Children's Hospital, Alder Hey Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Heather P. McDowell, MD    44-151-293-3679      
Middlesex Hospital Recruiting
London, England, United Kingdom, W1T 3AA
Contact: Ananth Shankar, MD    44-20-7380-9300 ext. 9950      
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Penelope Brock, MD, PhD    44-20-7829-7924   
Royal Manchester Children's Hospital Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD    44-161-922-2227   
Sir James Spence Institute of Child Health at Royal Victoria Infirmary Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Juliet Hale, MD    44-191-282-4101   
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH    44-115-924-9924 ext. 43394   
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Kate Wheeler, MD    44-186-522-1066      
Children's Hospital - Sheffield Recruiting
Sheffield, England, United Kingdom, S10 2TH
Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH    44-114-271-7366   
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Janice A. Kohler, MD, FRCP    44-23-8079-6942      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Mary Taj, MD    44-20-8642-6011 ext. 1307      
Royal Belfast Hospital for Sick Children Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Contact: Anthony McCarthy, MD    44-289-063-3631   
Royal Aberdeen Children's Hospital Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Contact: Veronica Neefjes    44-1224-550-217      
Royal Hospital for Sick Children Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD    44-131-536-0426      
Royal Hospital for Sick Children Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD    44-141-201-9309      
Childrens Hospital for Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Heidi Traunecker, MD, PhD    44-29-2074-2285   
Sponsors and Collaborators
University of Leicester
Study Chair: Ruth Ladenstein, MD St. Anna Kinderkrebsforschung

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00030719     History of Changes
Other Study ID Numbers: CDR0000069191
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: August 2010

Keywords provided by National Cancer Institute (NCI):
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists