Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma Who Are Undergoing Surgery With or Without Autologous Bone Marrow or Peripheral Stem Cell Transplant

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: NCT00417053
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : December 28, 2006
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy 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. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known which combination chemotherapy regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, is more effective in treating newly diagnosed neuroblastoma.

PURPOSE: This phase III trial is studying combination chemotherapy to see which regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, works in treating infants with newly diagnosed neuroblastoma.

Condition or disease Intervention/treatment Phase
Neuroblastoma Biological: filgrastim Drug: busulfan Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: melphalan Drug: vincristine sulfate Procedure: autologous bone marrow transplantation 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)
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: European Infant Neuroblastoma Study Final Protocol

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed neuroblastoma or ganglioblastoma

    • Newly diagnosed disease
  • MYCN status known
  • Patients are assigned to different study treatment regimens* according to the following disease criteria:

    • Regimen NB 99.1

      • Localized unresectable tumor

        • If open surgery is considered too hazardous due to the site of the tumor or condition of the infant, then cytological confirmation is allowed, provided adequate material is obtained for study procedures
      • No MYCN amplification (i.e., < 10 copies)
      • No metastatic deposits in the bone marrow
      • No MIBG or technetium uptake or radiological bone lesions in the skeleton
      • No liver disease by ultrasound
    • Regimen NB 99.2

      • Stage 4 or 4S with metastases confined to the skin, marrow, nodes, or liver

        • No bone involvement by radiographs
        • No pleural or lung involvement
        • No CNS involvement
      • No MYCN amplification (i.e., < 10 copies)
    • Regimen NB 99.3

      • Stage 4 disease, metastases must meet ≥ 1 of the following criteria:

        • Skeletal bone metastases by plain x-ray or CT scan
        • Pleural or lung metastases
        • CNS involvement
      • No MYCN amplification (i.e., < 10 copies)
    • Regimen NB 99.4

      • Stage 2-4 disease
      • MYCN amplification (i.e., ≥ 10 copies) NOTE: *Patients with stage 1 or resectable stage 2 disease with no MYCN amplification ( i.e., < 10 copies) are not eligible for a study treatment regimen but may be enrolled on the study for observation only


  • Not specified


  • No prior 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): NCT00417053

Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Study Chair: Mary P. Gerrard, MBChB, FRCP, FRCPCH Children's Hospital - Sheffield Identifier: NCT00417053     History of Changes
Other Study ID Numbers: CCLG-NB-1999-03
CDR0000454507 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: December 2006

Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S 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
Liposomal doxorubicin
Etoposide phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors