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 recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00417053
First received: December 27, 2006
Last updated: August 1, 2013
Last verified: December 2006
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: European Infant Neuroblastoma Study Final Protocol

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417053

Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: Mary P. Gerrard, MBChB, FRCP, FRCPCH Children's Hospital - Sheffield
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00417053     History of Changes
Other Study ID Numbers: CCLG-NB-1999-03, CDR0000454507, EU-20597
Study First Received: December 27, 2006
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Liposomal doxorubicin
Etoposide phosphate
Doxorubicin
Vincristine
Etoposide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014