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Multiple Therapies in Treating Patients With Advanced Neuroblastoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: July 8, 2002
Last updated: March 6, 2013
Last verified: March 2013

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining different types of therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, monoclonal antibody therapy, surgery, peripheral stem cell transplantation, radiation therapy, and biological therapy in treating patients who have advanced neuroblastoma.

Condition Intervention Phase
Neuroblastoma Biological: filgrastim Biological: monoclonal antibody 3F8 Biological: sargramostim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: isotretinoin Drug: thiotepa Drug: topotecan hydrochloride Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: conventional surgery Procedure: drug resistance inhibition treatment Procedure: peripheral blood stem cell transplantation Procedure: syngeneic bone marrow transplantation Radiation: radiation therapy Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: N8: Dose-Intensive Chemotherapy Plus Biologics in the Treatment of Neuroblastoma

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: June 2000
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of neuroblastoma by 1 of the following:

    • Histologic confirmation, including immunohistochemical, ultrastructural, or cytogenetic studies
    • Elevated urinary catecholamines plus tumor cells/clumps in the bone marrow
  • Poor-risk disease, defined by 1 of the following:

    • Stage IV disease
    • Unresectable primary disease plus N-myc amplification
    • Infant (under age 1) with stage IV disease plus N-myc amplification
  • Previously treated disease allowed



  • 50 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No prior allergy to mouse proteins
  • Not pregnant
  • Fertile patients must use effective contraception


Biologic therapy:

  • Prior murine antibodies allowed if human anti-mouse antibody (HAMA) titer is less than 1,000 ELISA units/mL


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics
  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 identifier: NCT00040872

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Nai-Kong V. Cheung, MD, PhD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00040872     History of Changes
Other Study ID Numbers: 00-065
P30CA008748 ( US NIH Grant/Contract Award Number )
Study First Received: July 8, 2002
Last Updated: March 6, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
regional neuroblastoma
disseminated neuroblastoma
recurrent 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
Liposomal doxorubicin
Antibodies, Monoclonal
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on June 26, 2017