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Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025428
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase III

MedlinePlus related topics:   Cancer    Neuroblastoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Carboplatin    Etoposide    Vincristine sulfate    Vincristine    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

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

Primary Outcome Measures:
  • Event-free survival at 3 years [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   December 2000

Detailed Description:

OBJECTIVES:

  • Determine the outcome, in terms of local control, event-free survival, and overall survival, of children with localized unresectable neuroblastoma without MYCN amplification treated with carboplatin, etoposide, cyclophosphamide, doxorubicin, and vincristine followed by surgery.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours on days 1-3 (courses 1 and 3). Patients receive cyclophosphamide IV over 1 hour on days 1-5 (or orally on days 2 and 3), doxorubicin IV over 6 hours on days 4-5, and vincristine IV on days 1 and 5 (courses 2 and 4). Treatment repeats every 21 days for 4 courses. Patients then undergo surgical resection followed by 2 additional courses of chemotherapy.

Patients are followed at months 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, and 60.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 4 years.

  Eligibility
Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of localized unresectable neuroblastoma

    • Stage II or III
    • No MYCN amplification

PATIENT CHARACTERISTICS:

Age:

  • Over 1

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025428

Locations
Austria
St. Anna Children's Hospital    
      Vienna, Austria, A-1090
Belgium
Universitair Ziekenhuis Gent    
      Ghent, Belgium, B-9000
Denmark
Odense University Hospital    
      Odense, Denmark, DK-5000
France
Centre Hospitalier Regional de Purpan    
      Toulouse, France, 31026
Germany
Children's Hospital    
      Cologne, Germany, D-50924
Italy
Istituto Giannina Gaslini    
      Genoa, Italy, 16148
Norway
Rikshospitalet University Hospital    
      Oslo, Norway, 0027
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.    
      Lisboa, Portugal, 1099-023 Codex
Spain
Hospital Universitario LA FE    
      Valencia, Spain, 46009
Sweden
Ostra Sjukhuset    
      Gothenburg, Sweden, 41685
Switzerland
Centre Hospitalier Universitaire Vaudois    
      Lausanne, Switzerland, CH-1011
United Kingdom, England
Southampton University Hospital NHS Trust    
      Southampton, England, United Kingdom, SO16 6YD

Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group

Investigators
Study Chair:     Janice A. Kohler, MD, FRCP     Southampton General Hospital    
Study Chair:     Janice A. Kohler, MD, FRCP     Southampton General Hospital    
  More Information


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

Study ID Numbers:   CDR0000068960, SIOP-NB-2009, CCLG-NB-2000-09, EU-20107
First Received:   October 11, 2001
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00025428
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized unresectable neuroblastoma  

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Vincristine
Cyclophosphamide
Carboplatin
Etoposide phosphate
Neuroblastoma
Doxorubicin
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Etoposide
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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