Chemotherapy and Surgery Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic 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: NCT00024193
Recruitment Status : Unknown
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Societe Francaise Oncologie Pediatrique
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. Chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation may be an effective treatment for metastatic neuroblastoma.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation in treating patients who have metastatic neuroblastoma.

Condition or disease Intervention/treatment Phase
Neuroblastoma Biological: filgrastim Drug: busulfan Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: melphalan Drug: vincristine sulfate Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • Determine the efficacy of induction chemotherapy followed by surgical resection and consolidation chemotherapy with autologous peripheral blood stem cell transplantation in patients with metastatic neuroblastoma.
  • Determine the tolerability and feasibility of this regimen in these patients.
  • Determine the medium and long-term results in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days 1 and 2 and doxorubicin IV continuously and vincristine IV continuously over days 1-3 of courses 1, 2, 4, and 6. Patients receive cisplatin IV over 1 hour on days 1-4 and etoposide IV over 2 hours on days 1-3 of induction courses 3, 5, and 7. Patients also receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 5 of courses 3, 5, and 7 and continuing until blood counts recover. Treatment repeats every 21 days.

At the completion of induction chemotherapy, patients undergo surgical resection. Patients in complete remission receive high-dose consolidation chemotherapy comprising oral busulfan every 6 hours on days -7 to -3 and melphalan IV over 2 minutes on day -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0. Patients with n-myc tumor amplification undergo radiotherapy at least 70 days after PBSC transplantation.

Patients are followed every 6 months.

PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Study Of The Treatment Of Metastatic Neuroblastoma In Children More Than One Year Of Age At Diagnosis
Study Start Date : April 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed primary neuroblastoma OR
  • Presence of neuroblasts in bone marrow associated with an elevation of urinary catecholamines
  • Metastatic disease demonstrated by at least 1 of the following:

    • Medullary invasion (bone marrow involvement) as indicated by bone uptake on meta-iodobenzyl guanidine I 123 or bone lesions on bone scan
    • Distant metastases to liver, pleura, lungs, or distant nodes
  • No 11-22 translocation



  • 1 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • See Disease Characteristics


  • No contraindications to study drugs


Biologic therapy

  • Not specified


  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

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): NCT00024193

Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
Study Chair: Janice A. Kohler, MD, FRCP University Hospital Southampton NHS Foundation Trust
Study Chair: D. Valteau-Couanet Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT00024193     History of Changes
Other Study ID Numbers: CCLG-NB-1999-02
CDR0000068899 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: November 2001

Keywords provided by National Cancer Institute (NCI):
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
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
Topoisomerase Inhibitors
Enzyme Inhibitors