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Multiple Therapies in Treating Patients With Advanced Neuroblastoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00040872
First received: July 8, 2002
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 50 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040872

Locations
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)
Investigators
Study Chair: Nai-Kong V. Cheung, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00040872     History of Changes
Other Study ID Numbers: 00-065, P30CA008748, MSKCC-00065, NCI-G02-2083
Study First Received: July 8, 2002
Last Updated: March 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
regional neuroblastoma
disseminated neuroblastoma
recurrent neuroblastoma
localized unresectable 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
Antibodies
Antibodies, Monoclonal
Cyclophosphamide
Thiotepa
Lenograstim
 Cisplatin
Doxorubicin
Etoposide
Vincristine
Carboplatin
Topotecan
Isotretinoin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Immunosuppressive Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013